Actively Recruiting
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-04-23
14
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
P
Prostate Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Histologically confirmed prostate carcinoma
- Progressing on continuous androgen ablative therapy (surgical castration or LHRH agonist)
- Documented castrate blood testosterone level below 50 ng/dL
- Progression after prior treatment with at least one Androgen Receptor Signaling Inhibitor
- Presence of biopsiable disease or available archival tissue
- Absolute neutrophil count of at least 1,200/µL
- Platelet count of at least 100,000/µL
- Total bilirubin no higher than 1.2 times institutional upper limit of normal
- AST and ALT not exceeding 3 times institutional upper limit of normal
- Creatinine clearance over 50 mL/min
- Measurable disease per RECIST 1.1 criteria
- Agreement to use adequate contraception if of child-bearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
- Unrecovered adverse events from prior treatments administered more than 4 weeks earlier
- Known brain metastases
- More than 5 sites of visceral disease in lung or liver (small lung nodules 1 cm or less allowed)
- Disease extent that poses risk from testosterone therapy (e.g., femoral or spinal metastases with fracture or compression risk)
- Active uncontrolled infection including AIDS or hepatitis B or C
- Psychological, familial, sociological, or geographical conditions interfering with study compliance
- History of thromboembolic event within last 12 months without current anticoagulation
- Hematocrit above 50%, untreated severe obstructive sleep apnea, or uncontrolled heart failure
- Serious unstable medical or psychiatric conditions
- Known allergy to testosterone cypionate or its excipients
- Unwillingness or inability to follow study protocol
- Any condition making participant unsuitable to receive study drug as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
A
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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