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

August 20, 2025 updated by: Dendreon

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85741
        • Recruiting
        • Arizona Urology Specialists
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope - National Medical Center
        • Contact:
          • Tanya Dorff Principal Investigator, MD
          • Phone Number: 626-218-6585
          • Email: mtuano@coh.org
      • Fresno, California, United States, 93720
        • Recruiting
        • Urology Associates of Central California Medical Group
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Unio Health Partners - Genesis Research, LLC
        • Contact:
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Urology
        • Contact:
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Advanced Urology Institute
        • Contact:
      • Largo, Florida, United States, 33771
      • Ocala, Florida, United States, 34471
      • Riverview, Florida, United States, 33578
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Active, not recruiting
        • Associated Urological Specialists
      • Glenview, Illinois, United States, 60026
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • Advanced Urology Associates
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Urology Of Indiana
        • Contact:
      • Jeffersonville, Indiana, United States, 47130
      • Merrillville, Indiana, United States, 46410
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology Research Associates
        • Contact:
    • Michigan
      • Troy, Michigan, United States, 48084
    • Missouri
      • St Louis, Missouri, United States, 63141
    • New York
      • North Hills, New York, United States, 11040
        • Recruiting
        • Integrated Medical Professionals
        • Contact:
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals of NY
        • Contact:
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Associated Urologists of North Carolina
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45212
      • Gahanna, Ohio, United States, 43230
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Oregon Urology Institute
        • Contact:
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Lancaster, Pennsylvania, United States, 17604
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Urology Institute
        • Contact:
      • Myrtle Beach, South Carolina, United States, 29572
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates of Nashville
        • Contact:
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Booster Arm

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess humoral immune response to PAP and PA2024 after booster infusion
Time Frame: Once all subjects have completed the study through the 5 year Overall Survival Period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
Time Frame: Once all subjects have completed the study through the 5 year Overall Survival Period
For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups.
Once all subjects have completed the study through the 5 year Overall Survival Period
Evaluate Overall Survival
Time Frame: 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
Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess biomarkers of response to treatment
Time Frame: Once all subjects have completed the study through the 5 year Overall Survival Period
Biomarkers, such as cytokines, will be assessed for response to booster treatment using appropriate descriptive statistics assessed over time and at Week 28. Nominal p-values will be provided without multiplicity adjustment .appropriate descriptive statistics assessed over time and at Week 28.
Once all subjects have completed the study through the 5 year Overall Survival Period
Assess Antigen Response
Time Frame: Once all subjects have completed the study through the 5 year Overall Survival Period
Comparison of (over time and at Week 38), the number of subjects per treatment arm with PAP and PA2024 antigen positive response using descriptive statistics.
Once all subjects have completed the study through the 5 year Overall Survival Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Collaborators

Talosix
WCG IRB

Investigators

  • Study Director: Nadeem Sheikh, PhD, Dendreon Pharmaceuticals, LLC
  • Study Chair: Benjamin Lowentritt, MD, Chesapeake Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

June 30, 2032

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Based on precedent, only IPD used in the results publication may be shared; however, the internal Dendreon team has not yet discussed this.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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