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NCT06134232PHASE2Recruiting

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

Dendreon

Start Date

10/2/2023

Completion Date

6/30/2032

Summary

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

Detailed Description

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: For a subject to be eligible for participation in this study, all of the following criteria must be satisfied: 1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. Have qualified for on-label PROVENGE® infusion 3. Have received all 3 infusions of PROVENGE® prior to randomization 4. Written informed consent provided prior to the initiation of study procedures 5. Estimated life expectancy ≥12 months Exclusion Criteria: A subject will not be eligible for participation in this study if any of the following criteria apply. 1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1) 3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment. 4. On experimental or investigational therapy.

Interventions

DRUG

Sipuleucel-T Injection

Interested in This Trial?

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Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Locations

Arizona Urology Specialists

Tuscon, Arizona 85741

United States

City of Hope - National Medical Center

Duarte, California 91010

United States

Urology Associates of Central California Medical Group

Fresno, California 93720

United States

Unio Health Partners - Genesis Research, LLC

San Diego, California 92123

United States

Colorado Urology

Lakewood, Colorado 80228

United States

Advanced Urology Institute

Daytona Beach, Florida 32114

United States

Advanced Urology Institute

Largo, Florida 33771

United States

Advanced Urology Institute

Ocala, Florida 34471

United States

Florida Urology Partners

Riverview, Florida 33578

United States

Associated Urological Specialists

Chicago Ridge, Illinois 60415

United States

UroPartners

Glenview, Illinois 60026

United States

Advanced Urology Associates

New Lenox, Illinois 60451

United States

Urology of Indiana

Carmel, Indiana 46032

United States

First Urology

Jeffersonville, Indiana 47130

United States

Urologic Specialists of Northwest Indiana

Merrillville, Indiana 46410

United States

Chesapeake Urology Research Associates

Towson, Maryland 21204

United States

Michigan Institute of Urology

Troy, Michigan 48084

United States

Specialty Clinical Research of St. Louis

St Louis, Missouri 63141

United States

Integrated Medical Professionals

North Hills, New York 11040

United States

Associated Medical Professionals of NY

Syracuse, New York 13210

United States

Associated Urologists of North Carolina

Raleigh, North Carolina 27612

United States

The Urology Group

Cincinnati, Ohio 45212

United States

Central Ohio Urology Group

Gahanna, Ohio 43230

United States

Oregon Urology Institute

Springfield, Oregon 97477

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Keystone Urology Specialists

Lancaster, Pennsylvania 17604

United States

Lowcountry Urology Institute

Charleston, South Carolina 29406

United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina 29572

United States

Urology Associates of Nashville

Nashville, Tennessee 37209

United States

Urology of Virginia

Virginia Beach, Virginia 23462

United States

Spokane Urology

Spokane, Washington 99202

United States