Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Roswell Park Cancer Institute
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.
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 rec…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion 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) * Documented castrate level of blood testosterone (\< 50 ng/dL) * Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) (by prostate specific antigen \[PSA\] criteria or radiographically) * Have biopsiable disease (a fresh biopsy is not required at baseline if adequ…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT scan
- DrugLeuprolide Acetate
Given SC
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherSurvey Administration
Ancillary studies
- DrugTestosterone Cypionate
Given IM
Location
- Roswell Park Cancer InstituteBuffalo, New York