Historical Perspective of HER2 Testing and Treatment in Prostate Cancer.
Natalia Zamalloa, Jacqueline Rose, Coen J Lap...
https://pubmed.ncbi.nlm.nih.gov/41744855Actively Recruiting
Phase 2
Age: 18Years +
MALE
ID06610825
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
Led by Washington D.C. Veterans Affairs Medical Center · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Enhertu as a treatment for men with HER2-positive metastatic castration-resistant prostate cancer (mCRPC) who have not responded to prior androgen deprivation therapy and novel hormonal agents. This Phase II trial focuses on patients who are either not candidates for or have declined taxane-based chemotherapy. The study is led by Dr. Maneesh Jain at the Washington DC VA and aims to assess both the effectiveness and safety of Enhertu. Participants will receive Enhertu as a single-arm treatment in an open-label, multi-center setting. The study will include 60 men who meet the criteria and will monitor the drug's anti-tumor activity and safety profile. The treatment involves ongoing androgen deprivation therapy to maintain low testosterone levels, and patients must provide tumor tissue samples for HER2 testing. During the study, participants will be regularly assessed for tumor response, progression-free survival, overall survival, and quality of life over a two-year period. Researchers will monitor heart function, blood clotting, organ health, and other safety parameters. The study involves continuous evaluation to measure the duration and control of disease response while ensuring participant safety throughout the trial period.
CONDITIONS
Brief Title
Castrate Resistant Prostate Cancer Enhertu Therapy
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed adenocarcinoma of the prostate
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
- Documented progression on androgen deprivation therapy and novel hormonal agents, with or without progression on taxane chemotherapy
- Ongoing androgen deprivation therapy to maintain serum testosterone below 50 ng/dL
- Availability of formalin-fixed paraffin-embedded tumor tissue for HER2 testing
- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Left ventricular ejection fraction (LVEF) of at least 50%
- Adequate blood clotting function
- Adequate organ and bone marrow function
- Adequate kidney function
- Adequate liver function
You will not qualify if you...
- History of interstitial lung disease or pneumonitis requiring steroid treatment
- Significant coronary vascular disease
- Prior treatment with HER2-targeted therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive Enhertu as a subsequent line of therapy for HER2-positive metastatic castration-resistant prostate cancer.
Trial Site Locations
Total: 1 location
1
Washington DC VAMC
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
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Research Team
A
Asha Escobar
M
Martha Antonio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer.
Rithika Rajendran, Coen J Lap, Siddharth Madapoosi...
https://pubmed.ncbi.nlm.nih.gov/40638235Response of Human Epidermal Growth Factor Receptor 2-Expressing Prostate Cancer to Trastuzumab Deruxtecan.
Coen J Lap, Rithika Rajendran, Jose Manuel Martin...
https://pubmed.ncbi.nlm.nih.gov/39496182The prevalence and clinical significance of HER2 expression in prostate adenocarcinoma.
Fayez Estephan, Coen J Lap, Jeff Banagan...
https://pubmed.ncbi.nlm.nih.gov/38622987