Treatment for HER2-Positive Metastatic Castration-Resistant Prostate Cancer
Official title: 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
Run by Washington D.C. Veterans Affairs Medical Center · NCT06610825 · Data updated 2026-11-12
This study is testing a new drug called Enhertu to see if it can help people with a specific type of advanced prostate cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Washington D.C. Veterans Affairs Medical Center Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | March 5, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06610825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men with pathologically confirmed adenocarcinoma of the prostate, diagnosed with mCRPC, and who have documented progression on prior therapies.
✕Probably not a fit
Patients with a history of interstitial lung disease or those who have previously received HER2 targeted therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II clinical trial evaluates the efficacy and safety of Enhertu in patients with HER2-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen deprivation therapy and novel hormonal agents. The open-label, multi-center study will enroll 60 participants who are either not candidates for or have refused taxane-based chemotherapy. The primary focus is on objective response rates, while secondary endpoints include safety, progression-free survival, overall survival, and quality of life measures.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive mCRPC who have limited treatment choices.
How similar studies have gone: Other studies have shown promising results with HER2-targeted therapies in similar contexts, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Washington DC VAMC
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Eric Knoche, MD — VA St. Louis Healthcare System
- Study coordinator: Asha Escobar
- Email: asha.escobar@va.gov
- Phone: 2027431090
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.