Federal Practitioner

TOPLINE: Veterans treated in the Veterans Health Administration (VHA) who had preexisting cardiometabolic disease and received androgen deprivation therapy (ADT) with radiation therapy developed major adverse cardiovascular events (MACE) at 4 times the rate compared to those without cardiometabolic disease. Black and White veterans showed similar cardiovascular outcomes regardless of treatment type.

METHODOLOGY: 
Researchers conducted a retrospective cohort study examining 39,580 veterans in the VHA system diagnosed with prostate cancer between 2000 and 2015, following them for a median of 9.6 years to assess time to MACE diagnosis.

•      Analysis utilized a 1:1 propensity score matching process to compare outcomes between treatment types (ADT with radiation therapy vs radiation therapy alone) and racial groups (Black vs White men).
•      Participants had a mean age of 65.9 years at diagnosis; 68% identified as White and 32% as Black, and 83% had stage 2 disease classified with 43.1% intermediate risk. Most lived in nonrural zip codes
•      Primary outcome measure was time to MACE, defined as a composite of cardiovascular death, myocardial infarction, or ischemic stroke, with patients censored at non-cardiovascular death or study end.

TAKEAWAY:
Compared to those without CMD, the hazard ratio (HR) for MACE for men with preexisting CMD who received ADT was 4.2. Those receiving radiation alone had an HR of 2.5.

•      Patients diagnosed between 2010 and 2015 showed significantly lower MACE rates compared to those diagnosed in 2000 to 2005: HR, 0.23; 95% CI, 0.08-0.71 for White patients; and HR, 0.23; 95% CI, 0.07-0.77 for Black patients.
•      Multiple comorbidities were associated with doubled MACE risk (HR, 2.22; 95% CI, 1.08-4.59) compared to those without comorbidities.
•      No significant differences in MACE rates were observed between Black and White veterans, regardless of treatment type.

IN PRACTICE: “Within the VHA, men treated with ADT + radiation therapy for prostate cancer do not appear to be at greater risk for MACE than those receiving radiation therapy alone. Black men have similar risk of MACE as White men, whether receiving radiation therapy alone or in combination with ADT," the authors wrote.

SOURCE: The study was led by Alexander R. Lucas, Virginia Commonwealth University School of Public Health in Richmond. It was published online on February 6 in Cardio-Oncology.

LIMITATIONS: According to the authors, the retrospective nature of the data may have limited their ability to detect MACE events occurring outside the VHA. Additionally, the study was limited to men who initiated ADT prior to radiation therapy, excluding those who had surgery or radiation before ADT. The researchers also note that the analysis did not compare outcomes between different types of ADT treatments, such as GnRH agonists vs antagonists, which may have different cardiovascular risk profiles.

DISCLOSURES: Alexander R. Lucas’s work was partly funded by grants 1KO1HL161419 and NRG FP00019789. Ashit K. Paul disclosed receiving honorarium for serving on scientific consultancy panels of SANOFI-Genzyme, Bayer, and Tempus & Cardinal Health. Additional disclosures are noted but not specified in the article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication

TOPLINE: Veterans treated in the Veterans Health Administration (VHA) who had preexisting cardiometabolic disease and received androgen deprivation therapy (ADT) with radiation therapy developed major adverse cardiovascular events (MACE) at 4 times the rate compared to those without cardiometabolic disease. Black and White veterans showed similar cardiovascular outcomes regardless of treatment type.

METHODOLOGY: 
Researchers conducted a retrospective cohort study examining 39,580 veterans in the VHA system diagnosed with prostate cancer between 2000 and 2015, following them for a median of 9.6 years to assess time to MACE diagnosis.

•      Analysis utilized a 1:1 propensity score matching process to compare outcomes between treatment types (ADT with radiation therapy vs radiation therapy alone) and racial groups (Black vs White men).
•      Participants had a mean age of 65.9 years at diagnosis; 68% identified as White and 32% as Black, and 83% had stage 2 disease classified with 43.1% intermediate risk. Most lived in nonrural zip codes
•      Primary outcome measure was time to MACE, defined as a composite of cardiovascular death, myocardial infarction, or ischemic stroke, with patients censored at non-cardiovascular death or study end.

TAKEAWAY:
Compared to those without CMD, the hazard ratio (HR) for MACE for men with preexisting CMD who received ADT was 4.2. Those receiving radiation alone had an HR of 2.5.

•      Patients diagnosed between 2010 and 2015 showed significantly lower MACE rates compared to those diagnosed in 2000 to 2005: HR, 0.23; 95% CI, 0.08-0.71 for White patients; and HR, 0.23; 95% CI, 0.07-0.77 for Black patients.
•      Multiple comorbidities were associated with doubled MACE risk (HR, 2.22; 95% CI, 1.08-4.59) compared to those without comorbidities.
•      No significant differences in MACE rates were observed between Black and White veterans, regardless of treatment type.

IN PRACTICE: “Within the VHA, men treated with ADT + radiation therapy for prostate cancer do not appear to be at greater risk for MACE than those receiving radiation therapy alone. Black men have similar risk of MACE as White men, whether receiving radiation therapy alone or in combination with ADT," the authors wrote.

SOURCE: The study was led by Alexander R. Lucas, Virginia Commonwealth University School of Public Health in Richmond. It was published online on February 6 in Cardio-Oncology.

LIMITATIONS: According to the authors, the retrospective nature of the data may have limited their ability to detect MACE events occurring outside the VHA. Additionally, the study was limited to men who initiated ADT prior to radiation therapy, excluding those who had surgery or radiation before ADT. The researchers also note that the analysis did not compare outcomes between different types of ADT treatments, such as GnRH agonists vs antagonists, which may have different cardiovascular risk profiles.

DISCLOSURES: Alexander R. Lucas’s work was partly funded by grants 1KO1HL161419 and NRG FP00019789. Ashit K. Paul disclosed receiving honorarium for serving on scientific consultancy panels of SANOFI-Genzyme, Bayer, and Tempus & Cardinal Health. Additional disclosures are noted but not specified in the article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication

TOPLINE: Veterans treated in the Veterans Health Administration (VHA) who had preexisting cardiometabolic disease and received androgen deprivation therapy (ADT) with radiation therapy developed major adverse cardiovascular events (MACE) at 4 times the rate compared to those without cardiometabolic disease. Black and White veterans showed similar cardiovascular outcomes regardless of treatment type.

METHODOLOGY: 
Researchers conducted a retrospective cohort study examining 39,580 veterans in the VHA system diagnosed with prostate cancer between 2000 and 2015, following them for a median of 9.6 years to assess time to MACE diagnosis.

•      Analysis utilized a 1:1 propensity score matching process to compare outcomes between treatment types (ADT with radiation therapy vs radiation therapy alone) and racial groups (Black vs White men).
•      Participants had a mean age of 65.9 years at diagnosis; 68% identified as White and 32% as Black, and 83% had stage 2 disease classified with 43.1% intermediate risk. Most lived in nonrural zip codes
•      Primary outcome measure was time to MACE, defined as a composite of cardiovascular death, myocardial infarction, or ischemic stroke, with patients censored at non-cardiovascular death or study end.

TAKEAWAY:
Compared to those without CMD, the hazard ratio (HR) for MACE for men with preexisting CMD who received ADT was 4.2. Those receiving radiation alone had an HR of 2.5.

•      Patients diagnosed between 2010 and 2015 showed significantly lower MACE rates compared to those diagnosed in 2000 to 2005: HR, 0.23; 95% CI, 0.08-0.71 for White patients; and HR, 0.23; 95% CI, 0.07-0.77 for Black patients.
•      Multiple comorbidities were associated with doubled MACE risk (HR, 2.22; 95% CI, 1.08-4.59) compared to those without comorbidities.
•      No significant differences in MACE rates were observed between Black and White veterans, regardless of treatment type.

IN PRACTICE: “Within the VHA, men treated with ADT + radiation therapy for prostate cancer do not appear to be at greater risk for MACE than those receiving radiation therapy alone. Black men have similar risk of MACE as White men, whether receiving radiation therapy alone or in combination with ADT," the authors wrote.

SOURCE: The study was led by Alexander R. Lucas, Virginia Commonwealth University School of Public Health in Richmond. It was published online on February 6 in Cardio-Oncology.

LIMITATIONS: According to the authors, the retrospective nature of the data may have limited their ability to detect MACE events occurring outside the VHA. Additionally, the study was limited to men who initiated ADT prior to radiation therapy, excluding those who had surgery or radiation before ADT. The researchers also note that the analysis did not compare outcomes between different types of ADT treatments, such as GnRH agonists vs antagonists, which may have different cardiovascular risk profiles.

DISCLOSURES: Alexander R. Lucas’s work was partly funded by grants 1KO1HL161419 and NRG FP00019789. Ashit K. Paul disclosed receiving honorarium for serving on scientific consultancy panels of SANOFI-Genzyme, Bayer, and Tempus & Cardinal Health. Additional disclosures are noted but not specified in the article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication

The clinical trials listed below are open as of March 10, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Actively Recruiting

Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

ID: NCT05396872

Sponsor; Investigator; Collaborator: University of California, San Francisco; Daniel Kwon, MD; US Department of Defense VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: San Francisco Veterans Affairs Medical Center, CA

Veterans Affairs Seamless Phase II/​III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT)

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

ID: NCT04787744

Sponsor; Collaborator: VA Office of Research and Development; Abhishek Solanki, MD, MS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 19 locations, including Edwards Hines Jr. VA Hospital, Hines, IL

The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS) (ProGRESS)

Prostate cancer is the most common non-skin cancer among veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that health care providers screen male veterans for prostate cancer.

ID: NCT05926102

Sponsor; Collaborator: VA Office of Research and Development; Jason L. Vassy, MD, MPH VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Boston Healthcare System Jamaica Plain Campus, MA

A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (SNARE)

The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.

ID: NCT05593497

Sponsor; Collaborator: VA Office of Research and Development; Ryan P. Kopp, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 5 locations, including VA Portland Health Care System, OR

18F-Fluciclovine PET/​CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

This is a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography (Axumin PET/CT) will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.

This study is open to veterans only.

ID: NCT06706921

Sponsor; Collaborator: VA Greater Los Angeles Healthcare System; Gholam Berenji, MD, Janake Wijesuriya, BS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Greater Los Angeles Healthcare System, CA

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (VA-BAT)

This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis.

ID: NCT05011383

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP)

The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objectives involve determining the frequency with which dMMR and CDK12-/- occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.

ID: NCT04104893

Sponsor; Investigator; Collaborator: VA Office of Research and Development; Matthew B. Rettig, MD; Merck Sharp & Dohme LLC VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 12 locations, including VA Greater Los Angeles Healthcare System, CA

Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA)

This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations.

Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28-day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

Participants then cross over from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.

ID: NCT04038502

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD; Ryan Burri, MD; Phoebe Tsao, MD, MSc; Maneesh Jain, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

The clinical trials listed below are open as of March 10, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Actively Recruiting

Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

ID: NCT05396872

Sponsor; Investigator; Collaborator: University of California, San Francisco; Daniel Kwon, MD; US Department of Defense VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: San Francisco Veterans Affairs Medical Center, CA

Veterans Affairs Seamless Phase II/​III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT)

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

ID: NCT04787744

Sponsor; Collaborator: VA Office of Research and Development; Abhishek Solanki, MD, MS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 19 locations, including Edwards Hines Jr. VA Hospital, Hines, IL

The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS) (ProGRESS)

Prostate cancer is the most common non-skin cancer among veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that health care providers screen male veterans for prostate cancer.

ID: NCT05926102

Sponsor; Collaborator: VA Office of Research and Development; Jason L. Vassy, MD, MPH VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Boston Healthcare System Jamaica Plain Campus, MA

A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (SNARE)

The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.

ID: NCT05593497

Sponsor; Collaborator: VA Office of Research and Development; Ryan P. Kopp, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 5 locations, including VA Portland Health Care System, OR

18F-Fluciclovine PET/​CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

This is a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography (Axumin PET/CT) will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.

This study is open to veterans only.

ID: NCT06706921

Sponsor; Collaborator: VA Greater Los Angeles Healthcare System; Gholam Berenji, MD, Janake Wijesuriya, BS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Greater Los Angeles Healthcare System, CA

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (VA-BAT)

This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis.

ID: NCT05011383

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP)

The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objectives involve determining the frequency with which dMMR and CDK12-/- occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.

ID: NCT04104893

Sponsor; Investigator; Collaborator: VA Office of Research and Development; Matthew B. Rettig, MD; Merck Sharp & Dohme LLC VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 12 locations, including VA Greater Los Angeles Healthcare System, CA

Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA)

This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations.

Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28-day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

Participants then cross over from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.

ID: NCT04038502

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD; Ryan Burri, MD; Phoebe Tsao, MD, MSc; Maneesh Jain, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

The clinical trials listed below are open as of March 10, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Actively Recruiting

Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

ID: NCT05396872

Sponsor; Investigator; Collaborator: University of California, San Francisco; Daniel Kwon, MD; US Department of Defense VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: San Francisco Veterans Affairs Medical Center, CA

Veterans Affairs Seamless Phase II/​III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT)

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

ID: NCT04787744

Sponsor; Collaborator: VA Office of Research and Development; Abhishek Solanki, MD, MS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 19 locations, including Edwards Hines Jr. VA Hospital, Hines, IL

The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS) (ProGRESS)

Prostate cancer is the most common non-skin cancer among veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that health care providers screen male veterans for prostate cancer.

ID: NCT05926102

Sponsor; Collaborator: VA Office of Research and Development; Jason L. Vassy, MD, MPH VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Boston Healthcare System Jamaica Plain Campus, MA

A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (SNARE)

The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.

ID: NCT05593497

Sponsor; Collaborator: VA Office of Research and Development; Ryan P. Kopp, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 5 locations, including VA Portland Health Care System, OR

18F-Fluciclovine PET/​CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

This is a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography (Axumin PET/CT) will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.

This study is open to veterans only.

ID: NCT06706921

Sponsor; Collaborator: VA Greater Los Angeles Healthcare System; Gholam Berenji, MD, Janake Wijesuriya, BS VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: VA Greater Los Angeles Healthcare System, CA

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (VA-BAT)

This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis.

ID: NCT05011383

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP)

The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objectives involve determining the frequency with which dMMR and CDK12-/- occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.

ID: NCT04104893

Sponsor; Investigator; Collaborator: VA Office of Research and Development; Matthew B. Rettig, MD; Merck Sharp & Dohme LLC VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 12 locations, including VA Greater Los Angeles Healthcare System, CA

Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA)

This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations.

Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28-day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

Participants then cross over from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.

ID: NCT04038502

Sponsor; Collaborator: VA Office of Research and Development; Robert B. Montgomery, MD; Ryan Burri, MD; Phoebe Tsao, MD, MSc; Maneesh Jain, MD VA Office of Research and Development; Madalina Macrea, MD, PhD

Location: 17 locations, including VA Puget Sound Health Care System, Seattle, WA

The US Department of Veterans Affairs (VA) has begun canceling 585 “non-mission–critical or duplicative” contracts, valued at about $1.8 billion. After accounting for the money already spent on the contracts, the VA expects to be able to redirect > $900 million back toward health care, benefits and services for VA beneficiaries.

This new directive, announced March 3, differs from the an earlier February contract cancellation plan. In late February, VA Secretary Doug Collins posted a video message on X outlining the cancellation of up to 875 contracts that was then relayed in an email to agency staff. In the post, Collins claimed to find “nearly $2 billion in VA contracts that we’ll be canceling so we can redirect the funds back to Veterans health care and benefits. No more paying consultants to do things like make Power Point slides and write meeting minutes!”

In a Feb. 25 statement Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) worried that the cancelled programs provided "critical services to veterans and their families, and allow VA to conduct oversight operations to identify waste, fraud, and abuse.” Blumenthal cited contracts to help process disability compensation benefits, modernize the VA Home Loan Program, cover medical services, provide cancer care, recruit doctors and other medical staff, and provide burial services to veterans. Within 24 hours of Blumenthal’s statement, VA leaders reversed their decision. 

This time, the VA insists the contract cancellations “were identified through a deliberative, multi-level review that involved the career subject-matter expert employees responsible for the contracts as well as VA senior leaders and contracting officials.” During the review, VA says it found many duplicative contracts that were providing the same services, such as third-party certifications for items like enhanced-use leases. The duplicative contracts were eliminated, while others remain to provide those services to ensure operational continuity.

The canceled contracts will be phased out over the next few days and represent < 1% of the roughly 90,000 current contracts worth > $67 billion, the VA said. According to the VA, contracts that directly support veterans and beneficiaries or provide services that VA cannot do itself, such as a nurse who sees patients or an organization that provides third-party certification services, respectively, were not canceled. 

The US Department of Veterans Affairs (VA) has begun canceling 585 “non-mission–critical or duplicative” contracts, valued at about $1.8 billion. After accounting for the money already spent on the contracts, the VA expects to be able to redirect > $900 million back toward health care, benefits and services for VA beneficiaries.

This new directive, announced March 3, differs from the an earlier February contract cancellation plan. In late February, VA Secretary Doug Collins posted a video message on X outlining the cancellation of up to 875 contracts that was then relayed in an email to agency staff. In the post, Collins claimed to find “nearly $2 billion in VA contracts that we’ll be canceling so we can redirect the funds back to Veterans health care and benefits. No more paying consultants to do things like make Power Point slides and write meeting minutes!”

In a Feb. 25 statement Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) worried that the cancelled programs provided "critical services to veterans and their families, and allow VA to conduct oversight operations to identify waste, fraud, and abuse.” Blumenthal cited contracts to help process disability compensation benefits, modernize the VA Home Loan Program, cover medical services, provide cancer care, recruit doctors and other medical staff, and provide burial services to veterans. Within 24 hours of Blumenthal’s statement, VA leaders reversed their decision. 

This time, the VA insists the contract cancellations “were identified through a deliberative, multi-level review that involved the career subject-matter expert employees responsible for the contracts as well as VA senior leaders and contracting officials.” During the review, VA says it found many duplicative contracts that were providing the same services, such as third-party certifications for items like enhanced-use leases. The duplicative contracts were eliminated, while others remain to provide those services to ensure operational continuity.

The canceled contracts will be phased out over the next few days and represent < 1% of the roughly 90,000 current contracts worth > $67 billion, the VA said. According to the VA, contracts that directly support veterans and beneficiaries or provide services that VA cannot do itself, such as a nurse who sees patients or an organization that provides third-party certification services, respectively, were not canceled. 

The US Department of Veterans Affairs (VA) has begun canceling 585 “non-mission–critical or duplicative” contracts, valued at about $1.8 billion. After accounting for the money already spent on the contracts, the VA expects to be able to redirect > $900 million back toward health care, benefits and services for VA beneficiaries.

This new directive, announced March 3, differs from the an earlier February contract cancellation plan. In late February, VA Secretary Doug Collins posted a video message on X outlining the cancellation of up to 875 contracts that was then relayed in an email to agency staff. In the post, Collins claimed to find “nearly $2 billion in VA contracts that we’ll be canceling so we can redirect the funds back to Veterans health care and benefits. No more paying consultants to do things like make Power Point slides and write meeting minutes!”

In a Feb. 25 statement Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) worried that the cancelled programs provided "critical services to veterans and their families, and allow VA to conduct oversight operations to identify waste, fraud, and abuse.” Blumenthal cited contracts to help process disability compensation benefits, modernize the VA Home Loan Program, cover medical services, provide cancer care, recruit doctors and other medical staff, and provide burial services to veterans. Within 24 hours of Blumenthal’s statement, VA leaders reversed their decision. 

This time, the VA insists the contract cancellations “were identified through a deliberative, multi-level review that involved the career subject-matter expert employees responsible for the contracts as well as VA senior leaders and contracting officials.” During the review, VA says it found many duplicative contracts that were providing the same services, such as third-party certifications for items like enhanced-use leases. The duplicative contracts were eliminated, while others remain to provide those services to ensure operational continuity.

The canceled contracts will be phased out over the next few days and represent < 1% of the roughly 90,000 current contracts worth > $67 billion, the VA said. According to the VA, contracts that directly support veterans and beneficiaries or provide services that VA cannot do itself, such as a nurse who sees patients or an organization that provides third-party certification services, respectively, were not canceled. 

Army Lt. Gen. Telita Crosland, MD, MPH, MS, fourth director of the Defense Health Agency (DHA) and first Black woman to hold the position, has retired, bringing an abrupt end to an illustrious 32-year military career. 

Acting Assistant Secretary of Defense for Health Affairs Stephen Ferrara, MD, said Crosland was “beginning her retirement” effective Feb. 28. According to Reuters, the statement offered no reasoning for Crosland’s quick departure, but 2 officials said she was informed that she must retire and was not given a reason why.

When she was promoted to director in January 2023, Lt. Gen. Crosland made history as the first Black woman to lead the DHA. Her former boss, Army Surgeon General Lt. Gen. R. Scott Dingle, called Crosland a “wonder woman” and “the baddest woman in the Army.” Her awards and decorations include the Legion of Merit with 2 oak leaf clusters, Meritorious Service Medal with 4 oak leaf clusters, Army Commendation Medal with 3 oak leaf clusters, Joint Service Achievement Medal, Army Staff Badge, and the Parachutist’s Badge. Lt. Gen. Crosland is also a member of the Order of Military Medical Merit. In addition to her medical and public health degrees, she has an master’s of science in national resource strategy.

Crosland entered the Army as a Medical Corps officer in 1993. Before becoming Director, she served as the Army’s Deputy Surgeon General, during which she oversaw response to a plethora of challenges: the COVID-19 pandemic, reformation of medical structures of the Army and other branches of services, and the Afghanistan withdrawal brought hundreds of evacuees with health needs. 

“It was a sporty 3 years,” Crosland said in an interview with Military Times and other media, shortly before her promotion ceremony. But the pandemic and the Afghanistan mission helped her clarify how the services can work together as a team, she said.

Then, following a congressional mandate in 2024, > 700 military medical, dental, and veterinary facilities from the Army, Navy, and Air Force were being shifted over to the DHA. “The transition was tough. It was tough,” Crosland said. “First of all, it’s change, arguably the largest change in the Department of Defense since the Air Force moved from the Army. We’re talking about bringing all the military health care systems into one entity. Change is difficult.”

But the essence of the services’ military health care has never changed, she said in the press conference. A family health physician, Crosland emphasized the importance of caring for all the 9.6 million beneficiaries in the Military Health System. “The pandemic showed what we’re for,” she said. “We’re still a military health care system that has to take care of the force, and the beneficiaries we’re privileged to serve.”

Family medicine is about the holistic person, Crosland said. “That will come out as I look at our health care system to make sure that ultimately that’s what we’re about … improving the health of an individual, whether you wear a uniform, you wore a uniform, or you served side-by-side with someone who wore a uniform.”

Crosland’s departure came just days before she was scheduled to speak at the AMSUS - Society of Federal Health Professionals’ annual military and federal health care conference. It also comes days after the Trump administration fired multiple top military leaders, including Joint Chiefs of Staff Chairman Gen. CQ Brown, Chief of Naval Operations Adm. Lisa Franchetti, Air Force Vice Chief of Staff Gen. James C. Slife and several top military lawyers.

Ferrara thanked Crosland “for her dedication to the nation, to the Military Health System, and to Army Medicine for the past 32 years.”

David Smith, MD, acting principal deputy assistant secretary of defense for health affairs, will serve as acting director of DHA while the US Department of Defense conducts a nomination process to replace Crosland.

Army Lt. Gen. Telita Crosland, MD, MPH, MS, fourth director of the Defense Health Agency (DHA) and first Black woman to hold the position, has retired, bringing an abrupt end to an illustrious 32-year military career. 

Acting Assistant Secretary of Defense for Health Affairs Stephen Ferrara, MD, said Crosland was “beginning her retirement” effective Feb. 28. According to Reuters, the statement offered no reasoning for Crosland’s quick departure, but 2 officials said she was informed that she must retire and was not given a reason why.

When she was promoted to director in January 2023, Lt. Gen. Crosland made history as the first Black woman to lead the DHA. Her former boss, Army Surgeon General Lt. Gen. R. Scott Dingle, called Crosland a “wonder woman” and “the baddest woman in the Army.” Her awards and decorations include the Legion of Merit with 2 oak leaf clusters, Meritorious Service Medal with 4 oak leaf clusters, Army Commendation Medal with 3 oak leaf clusters, Joint Service Achievement Medal, Army Staff Badge, and the Parachutist’s Badge. Lt. Gen. Crosland is also a member of the Order of Military Medical Merit. In addition to her medical and public health degrees, she has an master’s of science in national resource strategy.

Crosland entered the Army as a Medical Corps officer in 1993. Before becoming Director, she served as the Army’s Deputy Surgeon General, during which she oversaw response to a plethora of challenges: the COVID-19 pandemic, reformation of medical structures of the Army and other branches of services, and the Afghanistan withdrawal brought hundreds of evacuees with health needs. 

“It was a sporty 3 years,” Crosland said in an interview with Military Times and other media, shortly before her promotion ceremony. But the pandemic and the Afghanistan mission helped her clarify how the services can work together as a team, she said.

Then, following a congressional mandate in 2024, > 700 military medical, dental, and veterinary facilities from the Army, Navy, and Air Force were being shifted over to the DHA. “The transition was tough. It was tough,” Crosland said. “First of all, it’s change, arguably the largest change in the Department of Defense since the Air Force moved from the Army. We’re talking about bringing all the military health care systems into one entity. Change is difficult.”

But the essence of the services’ military health care has never changed, she said in the press conference. A family health physician, Crosland emphasized the importance of caring for all the 9.6 million beneficiaries in the Military Health System. “The pandemic showed what we’re for,” she said. “We’re still a military health care system that has to take care of the force, and the beneficiaries we’re privileged to serve.”

Family medicine is about the holistic person, Crosland said. “That will come out as I look at our health care system to make sure that ultimately that’s what we’re about … improving the health of an individual, whether you wear a uniform, you wore a uniform, or you served side-by-side with someone who wore a uniform.”

Crosland’s departure came just days before she was scheduled to speak at the AMSUS - Society of Federal Health Professionals’ annual military and federal health care conference. It also comes days after the Trump administration fired multiple top military leaders, including Joint Chiefs of Staff Chairman Gen. CQ Brown, Chief of Naval Operations Adm. Lisa Franchetti, Air Force Vice Chief of Staff Gen. James C. Slife and several top military lawyers.

Ferrara thanked Crosland “for her dedication to the nation, to the Military Health System, and to Army Medicine for the past 32 years.”

David Smith, MD, acting principal deputy assistant secretary of defense for health affairs, will serve as acting director of DHA while the US Department of Defense conducts a nomination process to replace Crosland.

Army Lt. Gen. Telita Crosland, MD, MPH, MS, fourth director of the Defense Health Agency (DHA) and first Black woman to hold the position, has retired, bringing an abrupt end to an illustrious 32-year military career. 

Acting Assistant Secretary of Defense for Health Affairs Stephen Ferrara, MD, said Crosland was “beginning her retirement” effective Feb. 28. According to Reuters, the statement offered no reasoning for Crosland’s quick departure, but 2 officials said she was informed that she must retire and was not given a reason why.

When she was promoted to director in January 2023, Lt. Gen. Crosland made history as the first Black woman to lead the DHA. Her former boss, Army Surgeon General Lt. Gen. R. Scott Dingle, called Crosland a “wonder woman” and “the baddest woman in the Army.” Her awards and decorations include the Legion of Merit with 2 oak leaf clusters, Meritorious Service Medal with 4 oak leaf clusters, Army Commendation Medal with 3 oak leaf clusters, Joint Service Achievement Medal, Army Staff Badge, and the Parachutist’s Badge. Lt. Gen. Crosland is also a member of the Order of Military Medical Merit. In addition to her medical and public health degrees, she has an master’s of science in national resource strategy.

Crosland entered the Army as a Medical Corps officer in 1993. Before becoming Director, she served as the Army’s Deputy Surgeon General, during which she oversaw response to a plethora of challenges: the COVID-19 pandemic, reformation of medical structures of the Army and other branches of services, and the Afghanistan withdrawal brought hundreds of evacuees with health needs. 

“It was a sporty 3 years,” Crosland said in an interview with Military Times and other media, shortly before her promotion ceremony. But the pandemic and the Afghanistan mission helped her clarify how the services can work together as a team, she said.

Then, following a congressional mandate in 2024, > 700 military medical, dental, and veterinary facilities from the Army, Navy, and Air Force were being shifted over to the DHA. “The transition was tough. It was tough,” Crosland said. “First of all, it’s change, arguably the largest change in the Department of Defense since the Air Force moved from the Army. We’re talking about bringing all the military health care systems into one entity. Change is difficult.”

But the essence of the services’ military health care has never changed, she said in the press conference. A family health physician, Crosland emphasized the importance of caring for all the 9.6 million beneficiaries in the Military Health System. “The pandemic showed what we’re for,” she said. “We’re still a military health care system that has to take care of the force, and the beneficiaries we’re privileged to serve.”

Family medicine is about the holistic person, Crosland said. “That will come out as I look at our health care system to make sure that ultimately that’s what we’re about … improving the health of an individual, whether you wear a uniform, you wore a uniform, or you served side-by-side with someone who wore a uniform.”

Crosland’s departure came just days before she was scheduled to speak at the AMSUS - Society of Federal Health Professionals’ annual military and federal health care conference. It also comes days after the Trump administration fired multiple top military leaders, including Joint Chiefs of Staff Chairman Gen. CQ Brown, Chief of Naval Operations Adm. Lisa Franchetti, Air Force Vice Chief of Staff Gen. James C. Slife and several top military lawyers.

Ferrara thanked Crosland “for her dedication to the nation, to the Military Health System, and to Army Medicine for the past 32 years.”

David Smith, MD, acting principal deputy assistant secretary of defense for health affairs, will serve as acting director of DHA while the US Department of Defense conducts a nomination process to replace Crosland.

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.