Spots Global Cancer Trial Database for Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

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