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Castrate Resistant Prostate Cancer Enhertu Therapy
NCT06610825 · Washington D.C. Veterans Affairs Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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 either not candidates for or have refused taxane based chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi center study will include 60 participants treated with Enhertu. Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.
Eligibility 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
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-05
Estimated completion: 2028-10
Last updated: 2026-04-13
Interventions
Drug: Enhertu
Primary outcomes
- • ORR (2 years)
Sponsor
Washington D.C. Veterans Affairs Medical Center · fed
With: Daiichi Sankyo, Cancer Research And Biostatistics, Institute for Clinical Research
Contacts & investigators
ContactAsha Escobar · contact · asha.escobar@va.gov · 2027431090
ContactMartha Antonio · contact · martha.antonio@va.gov
InvestigatorManeesh Jain, MD · study_chair, Washington DC VA Medical Center
InvestigatorEric Knoche, MD · principal_investigator, VA St. Louis Healthcare System
InvestigatorSuman Kambhampati, MD · principal_investigator, VA Kansas City
All locations (1)
Washington DC VAMCRecruiting
Washington D.C., District of Columbia, United States