Castrate Resistant Prostate Cancer Enhertu Therapy
Overview
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.
Who Can Participate
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
Disclaimer
This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.
Participation decisions can be made only after review by the study team and your treating clinician.