Treatment for HER2-Positive Metastatic Castration-Resistant Prostate Cancer
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
PHASE2 · Washington D.C. Veterans Affairs Medical Center · NCT06610825
This study is testing a new drug called Enhertu to see if it can help people with a specific type of advanced prostate cancer who haven't had success with other treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Washington D.C. Veterans Affairs Medical Center (fed) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06610825 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the efficacy and safety of Enhertu in patients with HER2-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen deprivation therapy and novel hormonal agents. The open-label, multi-center study will enroll 60 participants who are either not candidates for or have refused taxane-based chemotherapy. The primary focus is on objective response rates, while secondary endpoints include safety, progression-free survival, overall survival, and quality of life measures.
Who should consider this trial
Good fit: Ideal candidates include men with pathologically confirmed adenocarcinoma of the prostate, diagnosed with mCRPC, and who have documented progression on prior therapies.
Not a fit: Patients with a history of interstitial lung disease or those who have previously received HER2 targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive mCRPC who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with HER2-targeted therapies in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Washington DC VAMC — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Eric Knoche, MD — VA St. Louis Healthcare System
- Study coordinator: Asha Escobar
- Email: asha.escobar@va.gov
- Phone: 2027431090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer Metastatic, Prostate Cancer, CRPC, prostate cancer, metastatic prostate cancer, Enhertu, HER2 positive, Trastuzumab deruxtecan