Study on Enhertu Therapy for Castration-Resistant Prostate Cancer
Sponsor: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials ID:NCT06610825
This clinical trial is testing the drug Enhertu as a new treatment option for men with HER2-positive metastatic castration-resistant prostate cancer (mCRPC) who have not responded to previous hormone therapies and are not suitable for or have declined chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this Phase II study is to evaluate how well Enhertu works and how safe it is for men with HER2-positive metastatic castration-resistant prostate cancer (mCRPC). These patients have not responded to previous hormone treatments and are either not candidates for or have chosen not to undergo chemotherapy. The study, led by Dr. Maneesh Jain at the Washington DC VA, will involve 60 participants who will receive Enhertu. The main goal is to see how many patients respond to the treatment, while also monitoring safety, how long patients live without the cancer getting worse, overall survival, and quality of life.
Description
This study is designed to test the effectiveness and safety of Enhertu in men with HER2-positive metastatic castration-resistant prostate cancer (mCRPC). These patients have already tried hormone therapies but their cancer has continued to grow. They are either not suitable for chemotherapy or have chosen not to have it. The study will be conducted at multiple centers and will include 60 participants. The main focus is to see how many patients show a positive response to Enhertu. Researchers will also look at safety, how long patients live without the cancer progressing, overall survival, and quality of life. The study is led by Dr. Maneesh Jain at the Washington DC VA.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate adenocarcinoma.
- Have metastatic castration-resistant prostate cancer (mCRPC).
- Cancer has progressed despite hormone therapy, with or without progression on chemotherapy.
- Continuing hormone therapy to keep testosterone levels low.
- Available tumor tissue sample for HER2 testing.
- Life expectancy of at least 6 months.
- Good overall health with an ECOG performance status of 0 or 1.
- Heart's pumping ability of at least 50%.
- Good blood clotting, organ, bone marrow, kidney, and liver function.
Exclusion Criteria
- History of lung disease or inflammation requiring steroid treatment.
- Significant heart disease.
- Previous treatment with HER2-targeted therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington DC VAMC | 20422 | Washington DC | District of Columbia |
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