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Clinical Trials in the USA / NCT06134232
Recruiting Phase 2

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

NCT06134232 · tracked via the Priya Life Science USA tracker
Sponsor
Dendreon
Phase
Phase 2
Started
2023-10-02
Last updated
2025-08-27

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Investigational drug(s) / intervention(s)

Sipuleucel-T Injection

Sipuleucel-T Injection: Single Infusion

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Arizona Urology Specialists Tuscon Arizona Recruiting
City of Hope - National Medical Center Duarte California Recruiting
Urology Associates of Central California Medical Group Fresno California Recruiting
Unio Health Partners - Genesis Research, LLC San Diego California Recruiting
Colorado Urology Lakewood Colorado Recruiting
Advanced Urology Institute Daytona Beach Florida Recruiting
Advanced Urology Institute Largo Florida Recruiting
Advanced Urology Institute Ocala Florida Recruiting
Florida Urology Partners Riverview Florida Recruiting
Associated Urological Specialists Chicago Ridge Illinois Active Not Recruiting
UroPartners Glenview Illinois Recruiting
Advanced Urology Associates New Lenox Illinois Recruiting
Urology of Indiana Carmel Indiana Recruiting
First Urology Jeffersonville Indiana Recruiting
Urologic Specialists of Northwest Indiana Merrillville Indiana Recruiting
Chesapeake Urology Research Associates Towson Maryland Recruiting
Michigan Institute of Urology Troy Michigan Recruiting
Specialty Clinical Research of St. Louis St Louis Missouri Recruiting
Integrated Medical Professionals North Hills New York Recruiting
Associated Medical Professionals of NY Syracuse New York Recruiting
Associated Urologists of North Carolina Raleigh North Carolina Recruiting
The Urology Group Cincinnati Ohio Recruiting
Central Ohio Urology Group Gahanna Ohio Recruiting
Oregon Urology Institute Springfield Oregon Recruiting
MidLantic Urology Bala-Cynwyd Pennsylvania Recruiting
Keystone Urology Specialists Lancaster Pennsylvania Recruiting
Lowcountry Urology Institute Charleston South Carolina Recruiting
Carolina Urologic Research Center, LLC Myrtle Beach South Carolina Recruiting
Urology Associates of Nashville Nashville Tennessee Recruiting
Urology of Virginia Virginia Beach Virginia Recruiting
Spokane Urology Spokane Washington Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06134232 on ClinicalTrials.gov ↗ ← All trials in the USA