RecruitingPhase 2NCT06134232

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

Sponsor

Dendreon

Enrollment

400 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding an extra infusion of sipuleucel-T (a type of personalized cancer vaccine that stimulates the immune system) to the standard course of PROVENGE® (which already involves 3 infusions) can further improve immune response and outcomes in men with advanced prostate cancer that no longer responds to standard hormone therapy. **You may be eligible if...** - You are 18 or older and have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC) — cancer that has spread and is no longer responding to hormone therapy - You have completed all 3 standard PROVENGE® infusions - You have a life expectancy of at least 12 months **You may NOT be eligible if...** - You are on immunosuppressive medications (steroids, TNF-alpha blockers, etc.) - You have an active or uncontrolled infection or other serious illness - You are currently in another experimental treatment trial 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

DRUGSipuleucel-T Injection

Single Infusion

Locations(31)

Arizona Urology Specialists

Tuscon, Arizona, United States

City of Hope - National Medical Center

Duarte, California, United States

Urology Associates of Central California Medical Group

Fresno, California, United States

Unio Health Partners - Genesis Research, LLC

San Diego, California, United States

Colorado Urology

Lakewood, Colorado, United States

Advanced Urology Institute

Daytona Beach, Florida, United States

Advanced Urology Institute

Largo, Florida, United States

Advanced Urology Institute

Ocala, Florida, United States

Florida Urology Partners

Riverview, Florida, United States

Associated Urological Specialists

Chicago Ridge, Illinois, United States

UroPartners

Glenview, Illinois, United States

Advanced Urology Associates

New Lenox, Illinois, United States

Urology of Indiana

Carmel, Indiana, United States

First Urology

Jeffersonville, Indiana, United States

Urologic Specialists of Northwest Indiana

Merrillville, Indiana, United States

Chesapeake Urology Research Associates

Towson, Maryland, United States

Michigan Institute of Urology

Troy, Michigan, United States

Specialty Clinical Research of St. Louis

St Louis, Missouri, United States

Integrated Medical Professionals

North Hills, New York, United States

Associated Medical Professionals of NY

Syracuse, New York, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

The Urology Group

Cincinnati, Ohio, United States

Central Ohio Urology Group

Gahanna, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Lowcountry Urology Institute

Charleston, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Urology Associates of Nashville

Nashville, Tennessee, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Spokane Urology

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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

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NCT06134232

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