Status:
RECRUITING
Castrate Resistant Prostate Cancer Enhertu Therapy
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Collaborating Sponsors:
Daiichi Sankyo
Cancer Research And Biostatistics
Conditions:
Prostate Cancer Metastatic
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ei...
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
Key Trial Info
Start Date :
March 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06610825
Start Date
March 5 2025
End Date
October 1 2028
Last Update
July 28 2025
Active Locations (1)
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1
Washington DC VAMC
Washington D.C., District of Columbia, United States, 20422