RecruitingPhase 2NCT05751941

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

26 participants

Start Date

Feb 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the immune therapy sipuleucel-T (Provenge), combined with or without continuing hormone-suppressing drugs (called new hormonal agents or NHAs), is effective for men with metastatic prostate cancer whose PSA is rising while on hormone therapy but whose cancer has not yet progressed on scans. **You may be eligible if...** - You are 18 or older - You have metastatic prostate cancer confirmed by biopsy - You are currently on combined hormone therapy (LHRH analog + enzalutamide, apalutamide, or abiraterone) and your PSA level is rising, but imaging does not show cancer progression - You have a good health status (ECOG 0 or 1) and adequate blood counts and organ function **You may NOT be eligible if...** - Your prostate cancer has progressed on imaging scans - You are not currently on a new hormonal agent (NHA) therapy - You have had another active cancer in the past 3 years (with some exceptions) - Your organ function or blood counts are below the required levels 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.

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Interventions

DRUGAbiraterone

1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily

DRUGEnzalutamide

160 mg of Enzalutamide will be given orally daily ending at week 4

DRUGApalutamide

240 mg of Apalutamide will be given orally daily ending at week 4

DRUGSipuleucel-T

Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05751941


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