Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is an open label phase II, single-arm, biomarker multi-institutional pilot study. Men
with progressive metastatic castration-resistant prostate cancer (mCRPC) who have been
treated with androgen deprivation therapy (ADT) and at least one prior second generation
AR-targeted therapy (either abiraterone or enzalutamide) will be enrolled in this study. All
patients will receive treatment with testosterone cypionate 400 mg, intramuscular, every 28
days for a maximum of 3 cycles or limiting toxicity, if it occurs before the end of the
scheduled therapy. After 3 cycles of BAT (12 weeks), patients may continue receiving this
therapy off study at the discretion of the treating physician, if clinical/radiographic
benefit.
During the study period, patients will have plasma collected for cell-free tumor DNA analysis
and CTC ARV7 status and also will perform 68Gallium-PSMA PET at baseline and then every 6
weeks.