Recruiting
Phase 2

Enhertu

Sponsor:

Washington D.C. Veterans Affairs Medical Center

Code:

NCT06610825

Conditions

Prostate Cancer Metastatic

Prostate Cancer

CRPC

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhertu

Study Details

Brief summary:

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

Conditions

Prostate Cancer Metastatic

Prostate Cancer

CRPC

Study ID

NCT06610825

Start date

Mar 5, 2025

Status verified date

Apr, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhertu for HER2 positive metastatic castrate resistant prostate cancer

Interventions

Enhertu

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.

Primary outcome measure

  • ORR [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Asha Escobar

2027431090asha.escobar@va.gov

Martha Antonio

martha.antonio@va.gov

Locations

Washington DC VAMC

Recruiting

Washington D.C., District of Columbia, United States, 20422

Contacts

Asha Escobar

2027431090asha.escobar@Va.gov

Principal Investigator:

Maneesh Jain, MD

More Information

Sponsor

Washington D.C. Veterans Affairs Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington D.C. Veterans Affairs Medical Center on 2026-04-13.