Enhertu for HER2-Positive Metastatic Castrate-Resistant Prostate Cancer

This study is testing Enhertu in men with metastatic castrate-resistant prostate cancer (mCRPC) that has spread and is no longer responding to standard hormone treatments. To join, your prostate cancer must be HER2-positive, which is a specific biomarker (a biological sign in your body). You must also have already received androgen deprivation therapy (ADT) and other hormone agents. The study aims to see how well Enhertu shrinks tumors (objective response rate) over two years. This study is currently recruiting 60 participants.

Study design
This is an open-label, multi-center, single-arm Phase II study, meaning all 60 participants will receive Enhertu and everyone involved will know what treatment is being given.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, objective response rate, will be measured at 2 years.

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NCT06610825

Castrate Resistant Prostate Cancer Enhertu Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington D.C. Veterans Affairs Medical Center
~60 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Enhertu

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR
Measured over 2 years
Prostate Cancer Metastatic
Prostate Cancer
CRPC
1 sites across 1 states
District of Columbia1
  • 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

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Eligibility criteria

Inclusion

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

History of interstitial lung disease or pneumonitis requiring steroids
Significant coronary vascular disease
Previous exposure to HER2 targeted therapy
  • ORR2 years

    Objective Response Rate by local review, combining radiographic and biochemical responses