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Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06134232•Dendreon

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

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

Key Dates

Start Date

October 2, 2023

Primary Completion Date

December 31, 2031

Completion Date

June 30, 2032

Last Updated

August 27, 2025

Enrollment

400

ESTIMATED participants

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Sipuleucel-T Injection

DRUG

Contacts

Margaret Warner-Lubin

CONTACT

2064588358 ProvONE@dendreon.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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