Clinical Trial

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Active, Not Recruiting Phase 1

Summary

This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

Protocol Amendment History 6 changes

critical Enrollment closed, study ongoing 2026-08-08

notable Enrollment reduced: 14 -> 3 participants 2026-08-08

notable Primary completion moved earlier: 2029-12-15 -> 2026-03-09 2026-08-08

minor Completion moved earlier: 2029-12-15 -> 2028-03-09 2026-08-08

notable Primary completion pushed: 2026-12-15 -> 2029-12-15 2026-05-16

minor Completion pushed: 2027-12-15 -> 2029-12-15 2026-05-16

Trial Details

NCT Number	NCT06305598
Lead Sponsor	Roswell Park Cancer Institute Collaborators: Prostate Cancer Foundation
Conditions	Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment	3 participants
Start Date	2024-12-19
Primary Completion	2026-03-09 (estimated)
Study Completion	2028-03-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-07