RecruitingPhase 2NCT06610825

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


Sponsor

Washington D.C. Veterans Affairs Medical Center

Enrollment

60 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing trastuzumab deruxtecan (Enhertu) — a targeted therapy that delivers chemotherapy directly into cancer cells — for men with advanced prostate cancer that has stopped responding to hormone therapy (metastatic castrate-resistant prostate cancer, or mCRPC). Researchers want to see if Enhertu, which is already approved for some breast and lung cancers, can help prostate cancer patients. **You may be eligible if...** - You have prostate cancer confirmed by biopsy that is castrate-resistant and has spread to other parts of the body - You have progressed on hormone-blocking treatments (like enzalutamide or abiraterone) - You are maintaining low testosterone levels through ongoing treatment - You have a tumor tissue sample available for HER2 testing - Your heart, liver, kidney, and blood counts are in acceptable range - Your life expectancy is at least 6 months **You may NOT be eligible if...** - You have a history of interstitial lung disease or pneumonitis requiring steroids - You have significant heart or coronary artery disease - You have previously received a HER2-targeted therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Washington DC VAMC

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

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NCT06610825


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