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

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.

Trial Details

NCT ID

NCT06305598

Phase

PHASE1

Sponsor

Roswell Park Cancer Institute

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

Biopsy
Bone Scan
Computed Tomography
Leuprolide Acetate
Magnetic Resonance Imaging
Survey Administration

Locations (sample)

Buffalo, New York, United States|42.88645,-78.87837

Key Eligibility Criteria

Age ≥ 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Histologically confirmed carcinoma of the prostate
Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist)

For full eligibility, visit ClinicalTrials.gov.

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