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Bipolar Androgen Therapy for Metastatic Castration-Resistant Prostate Cancer

This study is testing a treatment called bipolar androgen therapy (BAT) for men with prostate cancer that has spread (metastatic) and is no longer responding to standard hormone therapy (castration-resistant). BAT involves giving testosterone to cycle between very low and very high levels in the body. Researchers want to see if this approach can make cancer cells sensitive to hormone therapy again, reduce side effects, and improve quality of life. You may be able to join if you are a man aged 18 or older, have confirmed prostate cancer that has spread and is progressing despite current hormone therapy, and meet other health criteria. The main goal is to see how BAT affects androgen receptor (AR) activity in cancer cells. The current status of this study is unclear.

Study design
This interventional study plans to enroll 14 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive testosterone injections every 28 days for three cycles and continue leuprolide acetate. You will also have CT scans, bone scans, and possibly MRI and tumor biopsies.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will have follow-up visits at 30 days and every 3 months for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06305598

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~3 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:BiopsyBone ScanComputed TomographyLeuprolide AcetateMagnetic Resonance ImagingSurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Androgen receptor (AR) activity
Measured over Up to 2 years after end of treatment/progression

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Saby George, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 × institutional ULN
Creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault equation)
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion

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
Unwilling or unable to follow protocol requirements
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

What this trial measures

  • Androgen receptor (AR) activityUp to 2 years after end of treatment/progression

    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.