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
Washington D.C. Veterans Affairs Medical Center
60 participants
Mar 5, 2025
INTERVENTIONAL
Conditions
Summary
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Eligibility
Inclusion Criteria12
- 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 Criteria3
- History of interstitial lung disease or pneumonitis requiring steroids
- Significant coronary vascular disease
- Previous exposure to HER2 targeted therapy
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06610825