Castrate Resistant Prostate Cancer Enhertu Therapy
United States60 participantsStarted 2025-03-05
Plain-language summary
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
ORR
Timeframe: 2 years
Trial details
NCT IDNCT06610825
SponsorWashington D.C. Veterans Affairs Medical Center