Sacituzumab Govitecan for Metastatic Castration-Resistant Prostate Cancer
Trial Summary
What is the purpose of this trial?
This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients with metastatic castration-resistant prostate cancer progressing on second generation androgen receptor (AR) directed therapy (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).
Research Team
Joshua Lang, MD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has worsened despite treatment like enzalutamide or abiraterone. They should have no other recent cancers, not had certain treatments recently, and must be in fairly good health with stable heart conditions. Participants need a biopsy available from their cancer and agree to use two forms of birth control if applicable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors for Castrate-Resistant Prostate Cancer. Treatment is administered on days 1 and 8 in a 21-day cycle, with a minimum of 3 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including PSA response and progression-free survival.
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival.
Treatment Details
Interventions
- IMMU-132
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine