Castrate Resistant Prostate Cancer Enhertu Therapy
Status
RECRUITING
Phase
PHASE2
Age
≥ 18 Years
Enrollments
60Conditions
Prostate Cancer Metastatic, Prostate Cancer, CRPCDrugs
EnhertuSummary
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 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.
Locations
1 location Found with status Recruiting
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 Plan
Enhertu for HER2 positive metastatic castrate resistant prostate cancer
DRUG:
EnhertuDescription:
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.
Outcome Measures
Primary Outcome Measures
ORR
Secondary Outcome Measures
Progression Free Survival
Overall Survival
Disease Control Rate
Duration of Response
Timeline
Last Updated
July 28, 2025Start Date
September 24, 2024Today
November 1, 2025Completion Date ( Estimated )
October 1, 2028
Sponsors of this trial
Lead Sponsor
Washington D.C. Veterans Affairs Medical CenterCollaborating Sponsors
Daiichi Sankyo, Cancer Research And Biostatistics, Institute for Clinical Research
RECRUITING 
≥ 18 Years