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

NCT06134232 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: P23-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Keywords

Single Dose; Sipuleucel-T; Immune Response Rate; Safety; Adenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (1)

• Assess humoral immune response to PAP and PA2024 after booster infusion

  To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not

  Once all subjects have completed the study through the 5 year Overall Survival Period

Secondary Outcomes (2)

• Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T

  Once all subjects have completed the study through the 5 year Overall Survival Period

• Evaluate Overall Survival

  Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating

Other Outcomes (2)

• Assess biomarkers of response to treatment

  Once all subjects have completed the study through the 5 year Overall Survival Period

• Assess Antigen Response

  Once all subjects have completed the study through the 5 year Overall Survival Period

Study Arms (2)

Booster Arm

EXPERIMENTAL

Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events.

Drug: Sipuleucel-T Injection

No Booster

NO INTERVENTION

No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.

Interventions

Sipuleucel-T Injection DRUG

Single Infusion

Booster Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
• 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).
• Have qualified for on-label PROVENGE® infusion
• Have received all 3 infusions of PROVENGE® prior to randomization
• Written informed consent provided prior to the initiation of study procedures
• Estimated life expectancy ≥12 months

You may not qualify if:

• A subject will not be eligible for participation in this study if any of the following criteria apply.
• Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
• 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)
• 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.
• On experimental or investigational therapy.

Sponsors & Collaborators

• Dendreon: lead
• WCG IRB: collaborator
• Talosix: collaborator

Study Sites (31)

Arizona Urology Specialists

Tuscon, Arizona, 85741, United States

RECRUITING

City of Hope - National Medical Center

Duarte, California, 91010, United States

RECRUITING

Urology Associates of Central California Medical Group

Fresno, California, 93720, United States

RECRUITING

Unio Health Partners - Genesis Research, LLC

San Diego, California, 92123, United States

RECRUITING

Colorado Urology

Lakewood, Colorado, 80228, United States

RECRUITING

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

RECRUITING

Advanced Urology Institute

Largo, Florida, 33771, United States

RECRUITING

Advanced Urology Institute

Ocala, Florida, 34471, United States

RECRUITING

Florida Urology Partners

Riverview, Florida, 33578, United States

RECRUITING

Associated Urological Specialists

Chicago Ridge, Illinois, 60415, United States

ACTIVE NOT RECRUITING

UroPartners

Glenview, Illinois, 60026, United States

RECRUITING

Advanced Urology Associates

New Lenox, Illinois, 60451, United States

RECRUITING

Urology of Indiana

Carmel, Indiana, 46032, United States

RECRUITING

First Urology

Jeffersonville, Indiana, 47130, United States

RECRUITING

Urologic Specialists of Northwest Indiana

Merrillville, Indiana, 46410, United States

RECRUITING

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

RECRUITING

Michigan Institute of Urology

Troy, Michigan, 48084, United States

RECRUITING

Specialty Clinical Research of St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

Integrated Medical Professionals

North Hills, New York, 11040, United States

RECRUITING

Associated Medical Professionals of NY

Syracuse, New York, 13210, United States

RECRUITING

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

RECRUITING

The Urology Group

Cincinnati, Ohio, 45212, United States

RECRUITING

Central Ohio Urology Group

Gahanna, Ohio, 43230, United States

RECRUITING

Oregon Urology Institute

Springfield, Oregon, 97477, United States

RECRUITING

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Keystone Urology Specialists

Lancaster, Pennsylvania, 17604, United States

RECRUITING

Lowcountry Urology Institute

Charleston, South Carolina, 29406, United States

RECRUITING

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology Associates of Nashville

Nashville, Tennessee, 37209, United States

RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

RECRUITING

Spokane Urology

Spokane, Washington, 99202, United States

RECRUITING

Related Links

• Dendreon Clinical Trial Summary Webpage

MeSH Terms

Interventions

sipuleucel-T

Study Officials

• Nadeem Sheikh, PhD

  Dendreon Pharmaceuticals, LLC

  STUDY DIRECTOR

• Benjamin Lowentritt, MD

  Chesapeake Urology

  STUDY CHAIR

Central Study Contacts

Margaret Warner-Lubin

CONTACT

2064588358; ProvONE@dendreon.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 18, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (31)