Actively Recruiting
Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Led by Roswell Park Cancer Institute · Updated on 2026-05-15
14
Participants Needed
1
Research Sites
N/A
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
Researchers are studying bipolar androgen therapy (BAT) in patients with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread to other parts of the body and no longer responds to traditional hormone-lowering treatments. This phase I trial aims to evaluate how BAT affects androgen receptor activity, potential side effects, and its ability to reduce prostate-specific antigen (PSA) levels, which may slow cancer progression and improve quality of life. Participants receive testosterone injections into the muscle once every 28 days for three cycles, while continuing their usual leuprolide acetate injections as standard care. Throughout the study, patients undergo various imaging tests such as CT scans, bone scans, and possibly MRI and tumor biopsies to monitor disease status. After completing treatment, follow-up visits occur at 30 days and then every three months for up to two years to assess long-term effects. During the study, researchers evaluate androgen receptor activity, side effects, fatigue, quality of life, measurable tumor responses, progression-free survival, and overall survival. Assessments include surveys, laboratory tests, and imaging studies. Safety is closely monitored, especially within 30 days after treatment ends, and the total participation time may last up to two years including follow-up visits.
CONDITIONS
Brief 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 0, 1, or 2
- Histologically confirmed prostate carcinoma
- Progressing despite continuous androgen ablative therapy (surgical castration or LHRH agonist)
- Documented castrate level of blood testosterone (< 50 ng/dL)
- Progressed after prior treatment with at least one androgen receptor signaling inhibitor based on PSA or imaging
- Presence of biopsiable disease or adequate archival tissue available
- Absolute neutrophil count ≥ 1,200/µL
- Platelets ≥ 100,000/µL
- Total bilirubin ≤ 1.2 times institutional upper limit of normal
- AST and ALT ≤ 3 times institutional upper limit of normal
- Creatinine clearance > 50 mL/min (Cockcroft-Gault equation)
- Measurable disease per RECIST 1.1 criteria
- Ability 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 before study entry (6 weeks for nitrosoureas or mitomycin C), or unresolved adverse events from prior therapy
- Known brain metastases
- More than 5 sites of visceral disease in lung or liver (small lung nodules ≤ 1 cm allowed)
- Disease extent posing risk from testosterone therapy (e.g., femoral or spinal metastases, lymph node obstruction 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 in past 12 months without systemic anticoagulation
- Hematocrit > 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure
- Serious unstable medical, psychiatric, or other conditions affecting safety or informed consent
- Known allergy to testosterone cypionate or its components
- Unwillingness or inability to follow protocol requirements
- Any condition making participant unsuitable for study drug in investigator's opinion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive testosterone injections once every 28 days for 3 cycles, while continuing their standard leuprolide acetate therapy. During this time, they undergo CT scans, bone scans, and possibly MRI and tumor biopsies to monitor their disease and response to treatment.
3 visits (in-person) for testosterone injections plus additional visits for scans and biopsies as needed
Duration - Up to 2 years
After completing treatment, participants attend follow-up visits to monitor safety, disease progression, quality of life, and fatigue for up to 2 years.
1 visit at 30 days post-treatment and then visits every 3 months
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
A
ASK RPCI
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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