Bipolar androgen therapy for advanced prostate cancer
Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This study is testing a new treatment that alternates testosterone levels to see if it can help men with advanced prostate cancer feel better and slow down their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06305598 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the effects of bipolar androgen therapy (BAT) on androgen receptor sensitivity in patients with metastatic castration-resistant prostate cancer (mCRPC). The approach involves alternating testosterone levels between low and high to potentially suppress cancer growth and reduce prostate-specific antigen (PSA) levels. Patients will receive testosterone injections along with standard care leuprolide acetate, and their response will be monitored through imaging and biopsies. The study aims to assess both the efficacy and safety of this treatment, as well as its impact on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adult men aged 18 and older with histologically confirmed metastatic castration-resistant prostate cancer who have progressed on prior treatments.
Not a fit: Patients who are not progressing on androgen ablative therapy or those without biopsiable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve treatment outcomes and quality of life for patients with advanced prostate cancer.
How similar studies have performed: While bipolar androgen therapy is a relatively novel approach, preliminary studies have shown promising results in enhancing androgen receptor sensitivity in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Niraj Shenoy, MD — Roswell Park Cancer Institute
- Study coordinator: Ask Rpci
- Email: askroswell@roswellpark.org
- Phone: 1-800-845-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.