NCT04424654

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy

Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Bipolar Androgen Therapy (BAT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Testosterone cypionate	Testosterone cypionate 400 mg IM

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-05-01
• Completion: 2022-07-01
• First posted: 2020-06-11
• Last updated: 2022-08-03

Locations

2 sites across 1 country: Brazil