NCT06305598

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

Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the influence of bipolar androgen therapy (BAT) on androgen receptor (AR) activity in patients with metastatic castration-resistant prostate cancer (mCRPC). SECONDARY OBJECTIVES: * To determine the clinical efficacy and safety of BAT in patients with mCRPC. * To determine the change in fatigue and quality of life in patients receiving BAT. OUTLINE: Patients receive testosterone intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also continue to receive standard of care leuprolide acetate subcutaneously (SC) per their standard schedule. Patients undergo computed tomography (CT) scan, bone scan and may undergo magnetic resonance imaging and tumor biopsy throughout the study. After completion of study treatment, patients follow up at 30 days and every 3 months for up to 2 years.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Computed Tomography	Undergo CT scan
DRUG	Leuprolide Acetate	Given SC
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Survey Administration	Ancillary studies
DRUG	Testosterone Cypionate	Given IM

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-12-15
• Completion: 2027-12-15
• First posted: 2024-03-12
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study