RecruitingNCT06610825CaRPETUpdated Apr 13, 2026

Castrate Resistant Prostate Cancer Enhertu Therapy

A Phase 2 interventional study of Enhertu in Prostate Cancer Metastatic, Prostate Cancer and CRPC, sponsored by Washington D.C. Veterans Affairs Medical Center. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Washington D.C. Veterans Affairs Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

Started Mar 2025; still recruiting 1 year 7 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 60
Allocation: Not applicable
Ages: 18 Years and older
Sex: Male

Study summary

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

Read the detailed description

This Phase II clinical trial aims to evaluate the efficacy and safety of Enhertu in HER-2 positive mCRPC who have progressed on prior androgen deprivation therapy and novel hormonal agents, who are either not candidates for or have refused taxane based chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi center study will include 60 participants treated with Enhertu. Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.

Conditions studied

Prostate Cancer Metastatic
Prostate Cancer
CRPC

Browse trials for

Prostatic Neoplasms 6,370

Keywords

prostate cancer
metastatic prostate cancer
Enhertu
HER2 positive
Trastuzumab deruxtecan
crpc
phase 2

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Washington D.C. Veterans Affairs Medical Center is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Pathologically confirmed adenocarcinoma of the prostate
Diagnosis of mCRPC
Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen
Ongoing ADT to maintain serum testosterone levels below 50 ng/dL
Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry
Life expectancy 6 months
ECOG 0 or 1
LVEF at least 50%
Adequate Blood Clotting function
Adequate Organ and Bone Marrow function
Adequate Renal function
Adequate Hepatic function

Exclusion criteria

Exclusion Criteria:

History of interstitial lung disease or pneumonitis requiring steroids
Significant coronary vascular disease
Previous exposure to HER2 targeted therapy

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Enhertu for HER2 positive metastatic castrate resistant prostate cancer
Drug: Enhertu

Interventions

DrugEnhertu
This is an open label, multi-center, single arm, phase II study designed to investigate the anti-tumor activity, efficacy and safety of Enhertu in HER2-positive metastatic castrate-resistant prostate cancer patients who progressed on androgen deprivation therapy and novel hormonal agents (such as Abiraterone and Enzalutamide), who also progressed, refused, or were not candidates to receive taxane-based chemotherapy.

What researchers measure

Primary outcomes

ORR
Objective Response Rate by local review, combining radiographic and biochemical responses
Time frame: 2 years

Secondary outcomes

Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Disease Control Rate
Time frame: 2 years
Duration of Response
Time frame: 2 years

Study locations

1 of 1 sites recruiting

Washington DC VAMC
Washington D.C., District of Columbia 20422, United States
- Asha Escobar · Contact · asha.escobar@Va.gov · 2027431090
- Maneesh Jain, MD · Principal investigator
Recruiting

References and documents

Publications

Zamalloa N, Rose J, Lap CJ, Rajendran R, Estephan F, Jatwani K, Poudel A, Subrahmanyam R, Hurley PJ, Nava VE, Jain M. Historical Perspective of HER2 Testing and Treatment in Prostate Cancer. Curr Oncol. 2026 Feb 2;33(2):91. doi: 10.3390/curroncol33020091. PubMed 41744855 ↗
Rajendran R, Lap CJ, Madapoosi S, Heiraty A, Estephan F, Hahn W, Poudel A, Nava VE, Subrahmanyam R, Jain M. Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer. Oncologist. 2025 Sep 1;30(9):oyaf207. doi: 10.1093/oncolo/oyaf207. PubMed 40638235 ↗
Lap CJ, Rajendran R, Martin JM, Uppal M, Escobar A, Heiraty AM, Estephan F, Hahn W, Subrahmanyam R, Nava VE, Jain M. Response of Human Epidermal Growth Factor Receptor 2-Expressing Prostate Cancer to Trastuzumab Deruxtecan. Ann Intern Med. 2024 Dec;177(12):1738-1741. doi: 10.7326/ANNALS-24-01409. Epub 2024 Nov 5. No abstract available. PubMed 39496182 ↗
Estephan F, Lap CJ, Banagan J, Antonio M, Liu S, Diao G, Rozalen AZ, Rajendran R, Krasnow S, Subrahmanyam R, Nava VE, Jain M. The prevalence and clinical significance of HER2 expression in prostate adenocarcinoma. Ann Diagn Pathol. 2023 Dec;67:152219. doi: 10.1016/j.anndiagpath.2023.152219. Epub 2023 Oct 20. PubMed 38622987 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06610825
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Collaborators: Daiichi Sankyo, Cancer Research And Biostatistics, Institute for Clinical Research
Responsible party: Sponsor
First posted: Sep 24, 2024
Start date: Mar 5, 2025
Primary completion: Oct 2027 (estimated)
Completion: Oct 2028 (estimated)
Last update: Apr 13, 2026

Study contacts

Asha Escobar

Contact

asha.escobar@va.gov

2027431090

Martha Antonio

Contact

martha.antonio@va.gov

Maneesh Jain, MD

study chair · Washington DC VA Medical Center

Eric Knoche, MD

principal investigator · VA St. Louis Healthcare System

Suman Kambhampati, MD

principal investigator · VA Kansas City

Julie Graff, MD

principal investigator · Portland VA Medical Center

Bruce Montgomery, MD

principal investigator · VA Puget Sound HCS

David Kosoff, MD

principal investigator · Wisconsin VA Medical Center

Kerry Schaffer, MD

principal investigator · Vanderbilt University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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