Castrate Resistant Prostate Cancer Enhertu Therapy (CaRPET)

April 6, 2026 updated by: Washington D.C. Veterans Affairs Medical Center

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20422
        • Recruiting
        • Washington DC VAMC
        • Contact:
        • Principal Investigator:
          • Maneesh Jain, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhertu for HER2 positive metastatic castrate resistant prostate cancer
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 2 years
Objective Response Rate by local review, combining radiographic and biochemical responses
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 2 years
2 years
Overall Survival
Time Frame: 2 years
2 years
Duration of Response
Time Frame: 2 years
2 years
Disease Control Rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington D.C. Veterans Affairs Medical Center

Collaborators

Institute for Clinical Research
Daiichi Sankyo
Cancer Research And Biostatistics

Investigators

  • Study Chair: Maneesh Jain, MD, Washington DC VA Medical Center
  • Principal Investigator: Eric Knoche, MD, VA St. Louis Healthcare System
  • Principal Investigator: Julie Graff, MD, Portland VA Medical Center
  • Principal Investigator: Bruce Montgomery, MD, VA Puget Sound HCS
  • Principal Investigator: David Kosoff, MD, Wisconsin VA Medical Center
  • Principal Investigator: Kerry Schaffer, MD, Vanderbilt University
  • Principal Investigator: Suman Kambhampati, MD, VA Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1803020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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