RecruitingPhase 1NCT06305598

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

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


Sponsor

Roswell Park Cancer Institute

Enrollment

14 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a strategy called "bipolar androgen therapy" — alternating between very high and very low testosterone levels — to see if it can re-sensitize advanced prostate cancer to standard hormone-blocking treatments that have stopped working. **You may be eligible if...** - You are 18 years or older with confirmed prostate cancer - Your cancer has spread (metastatic) and is no longer responding to standard hormone-blocking therapy - Your testosterone is at castrate levels (below 50 ng/dL) through surgery or injections - You have already been treated with at least one androgen receptor signaling inhibitor (such as enzalutamide or abiraterone) and your cancer has progressed - Your blood counts and organ function meet the required levels - Your general health is good enough to tolerate treatment (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has not yet been treated with standard hormone-blocking therapies - You have serious cardiovascular, liver, or kidney problems that make treatment unsafe - Your cancer no longer has measurable or evaluable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT scan

DRUGLeuprolide Acetate

Given SC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERSurvey Administration

Ancillary studies

DRUGTestosterone Cypionate

Given IM


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06305598


Related Trials