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.
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)
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted)
Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
Single group
Biopsy
Procedure/SurgeryUndergo biopsy
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT scan
Leuprolide Acetate
DrugGiven SC
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Survey Administration
Other interventionAncillary studies
Testosterone Cypionate
DrugGiven IM
Androgen receptor (AR) activity
Assessed with spatial transcriptomic profiling using the well-validated Nelson 10 genes signature AR score. Will be summarized by timepoint using the mean and standard deviation, and graphically using dot-plots. The mean pre/post-intervention levels will be compared using a one-sided paired t-test (expected increase); with the effect summarized using the mean difference and fold change.
Incidence of adverse events
Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Incidence of serious adverse events
Using the NCI CTCAE version 5.0.
Prostate specific antigen (PSA) 50
Defined as the proportion of patients with a \>=50% reduction in PSA from the maximal PSA level achieved during the treatment. Will be summarized using frequencies and relative frequencies.
Measurable disease response
Will be summarized using frequencies and relative frequencies.
Click on the lead sponsor to view all of their trials.
Roswell Park Cancer Institute
Lead sponsor
Prostate Cancer Foundation
Collaborator
