drugset / Trial / NCT06305598

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

NCT06305598

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-19
Primary completion
2029-12-15
Completion
2029-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Cypionate Small molecule Intramuscular
Background Leuprolide Other / unclassified Subcutaneous