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Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

NCT06305598•Roswell Park Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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 adequate archival tissue is available)
•Absolute neutrophil count: ≥1,200/µL
•Platelets: ≥ 100,000/µL
•Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)
+5 more criteria

Exclusion Criteria

•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)
•Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C
•Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
•Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation
•Hematocrit \> 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines)
•Evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
•Known allergy to testosterone cypionate or any of its excipients
+2 more criteria

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

December 19, 2024

Primary Completion Date

December 15, 2026

Completion Date

December 15, 2027

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

Interventions

Biopsy

PROCEDURE

Bone Scan

PROCEDURE

Computed Tomography

PROCEDURE

Leuprolide Acetate

DRUG

Magnetic Resonance Imaging

PROCEDURE

Survey Administration

OTHER

Testosterone Cypionate

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

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