Castrate Resistant Prostate Cancer Enhertu Therapy

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06610825

Acronym

CaRPET

Enrollment

Registered

2024-09-24

Start date

2025-03-05

Completion date

2028-10-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRPC, Prostate Cancer, Prostate Cancer Metastatic

Keywords

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

Brief summary

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

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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTAsha Escobar

asha.escobar@va.gov2027431090

CONTACTMartha Antonio

martha.antonio@va.gov

STUDY_CHAIRManeesh Jain, MD

Washington DC VA Medical Center

PRINCIPAL_INVESTIGATOREric Knoche, MD

VA St. Louis Healthcare System

PRINCIPAL_INVESTIGATORSuman Kambhampati, MD

VA Kansas City

PRINCIPAL_INVESTIGATORJulie Graff, MD

Portland VA Medical Center

PRINCIPAL_INVESTIGATORBruce Montgomery, MD

VA Puget Sound HCS

PRINCIPAL_INVESTIGATORDavid Kosoff, MD

Wisconsin VA Medical Center

PRINCIPAL_INVESTIGATORKerry Schaffer, MD

Vanderbilt University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026