OncoMatch/Clinical Trials/NCT06305598
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
Is NCT06305598 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Leuprolide Acetate and Testosterone Cypionate for castration-resistant prostate carcinoma.
Treatment: Leuprolide Acetate · Testosterone Cypionate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Androgen Receptor Signaling Inhibitor
Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) (by prostate specific antigen [PSA] criteria or radiographically)
Cannot have received: chemotherapy (nitrosoureas, mitomycin C)
Exception: within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: radiation therapy
Exception: within 4 weeks prior to entering the study
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Lab requirements
Blood counts
Absolute neutrophil count: ≥1,200/µL; Platelets: ≥ 100,000/µL
Kidney function
Creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN); AST/ALT: ≤ 3 × institutional ULN
Absolute neutrophil count: ≥1,200/µL; Platelets: ≥ 100,000/µL; Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN); AST/ALT: ≤ 3 × institutional ULN; Creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify