Castrate Resistant Prostate Cancer Enhertu Therapy
Launched by WASHINGTON D.C. VETERANS AFFAIRS MEDICAL CENTER · Sep 20, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Enhertu for men with a specific type of prostate cancer known as metastatic castration-resistant prostate adenocarcinoma (mCRPC) that tests positive for a protein called HER2. The trial is looking for participants who have already tried other treatments and are experiencing progression of their cancer. To be eligible, participants must have a confirmed diagnosis of prostate cancer, ongoing hormone therapy to keep their testosterone levels low, and a life expectancy of at least six months. They should also be in relatively good health, with no significant heart issues or prior exposure to HER2-targeted therapies.
Participants in the trial will receive the Enhertu therapy and will be monitored for their response to the treatment. The trial is currently recruiting men aged 65 to 74 who meet the eligibility criteria. It’s important to note that this trial aims to find new options for patients whose cancer has not responded to standard therapies, which can provide hope for better outcomes in their treatment journey.
Gender
MALE
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
About Washington D.C. Veterans Affairs Medical Center
The Washington D.C. Veterans Affairs Medical Center (DC VAMC) is a leading healthcare institution dedicated to providing comprehensive medical care, research, and education for veterans. As a prominent clinical trial sponsor, DC VAMC is committed to advancing medical knowledge and improving patient outcomes through innovative research initiatives. The center collaborates with various stakeholders, including academic institutions and industry partners, to conduct rigorous clinical trials that address the unique health needs of veterans. With a focus on evidence-based practices and patient-centered care, DC VAMC plays a vital role in enhancing the quality of healthcare for the veteran community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington Dc, District Of Columbia, United States
Patients applied
Trial Officials
Maneesh Jain, MD
Study Chair
Washington DC VA Medical Center
Eric Knoche, MD
Principal Investigator
VA St. Louis Healthcare System
Linda Verkruyse, MD
Principal Investigator
VA Kansas City
Julie Graff, MD
Principal Investigator
Portland VA Medical Center
Bruce Montgomery, MD
Principal Investigator
VA Puget Sound HCS
David Kosoff, MD
Principal Investigator
Wisconsin VA Medical Center
Karan Jatwani, MD
Principal Investigator
George Washington University Cancer Center
Kerry Schaffer, MD
Principal Investigator
Vanderbilt University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported