Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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) and at least one chemotherapy (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

Locations
United States
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 14
Treatments
Experimental: Treatment (Bipolar androgen therapy)
Patients receive testosterone 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 SC per their standard schedule. Patients undergo CT scan, bone scan and may undergo MRI and tumor biopsy throughout the study.
Sponsors
Leads: Roswell Park Cancer Institute

This content was sourced from clinicaltrials.gov

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