Actively Recruiting
An Open-Label Multicenter Study of Men With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE and Boosted With One Sipuleucel-T Infusion to Measure Immune Response
Led by Dendreon · Updated on 2025-08-27
400
Participants Needed
31
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Dendreon
Lead Sponsor
W
WCG IRB
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on men with metastatic castrate-resistant prostate cancer (mCRPC) who have previously been treated with PROVENGE4 immunotherapy. The study aims to investigate changes in immune responses following a booster dose of sipuleucel-T, an immunotherapy treatment. The trial is a phase 2, multicenter, open-label study designed to better understand immune boost responses in this patient group. Participants who have completed their initial treatment with PROVENGE4 will be randomly assigned to one of two groups: one group will receive a single booster infusion of sipuleucel-T approximately 6 to 9 months after their initial treatment, while the other group will not receive any additional intervention. The sipuleucel-T is delivered as an intravenous infusion. Both groups will be monitored according to the study schedule. Throughout the study, participants will undergo evaluations to measure immune responses to specific prostate cancer antigens after the booster infusion. Researchers will also monitor adverse events and overall survival over a 5-year period. The study involves regular follow-up visits to assess safety and immune activity, with total participation lasting up to five years after treatment.
CONDITIONS
Brief Title
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Clinically indicated for treatment with PROVENGE4 for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer
- Have qualified and received all three infusions of PROVENGE4 prior to randomization
- Provided written informed consent before study procedures
- Estimated life expectancy of 12 months or more
You will not qualify if you...
- Not clinically indicated for PROVENGE4 treatment for metastatic castrate-resistant 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 therapies
- Uncontrolled or active illness such as ongoing infections or psychiatric conditions that limit compliance with study requirements
- Currently on experimental or investigational therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion at 6 to 9 months post initial treatment
Participants receive a single infusion of sipuleucel-T as a booster treatment 6 to 9 months after completing their initial PROVENGE® immunotherapy course.
1 infusion visit (in-person)
Duration - Up to 5 years
Participants are monitored for immune response, adverse events, and overall survival for up to 5 years after treatment.
Regular follow-up visits as described in study schedule
Trial Site Locations
Total: 31 locations
1
Arizona Urology Specialists
Tuscon, Arizona, United States, 85741
Actively Recruiting
2
City of Hope - National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
Urology Associates of Central California Medical Group
Fresno, California, United States, 93720
Actively Recruiting
4
Unio Health Partners - Genesis Research, LLC
San Diego, California, United States, 92123
Actively Recruiting
5
Colorado Urology
Lakewood, Colorado, United States, 80228
Actively Recruiting
6
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
Actively Recruiting
7
Advanced Urology Institute
Largo, Florida, United States, 33771
Actively Recruiting
8
Advanced Urology Institute
Ocala, Florida, United States, 34471
Actively Recruiting
9
Florida Urology Partners
Riverview, Florida, United States, 33578
Actively Recruiting
10
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Active, Not Recruiting
11
UroPartners
Glenview, Illinois, United States, 60026
Actively Recruiting
12
Advanced Urology Associates
New Lenox, Illinois, United States, 60451
Actively Recruiting
13
Urology of Indiana
Carmel, Indiana, United States, 46032
Actively Recruiting
14
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
15
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, United States, 46410
Actively Recruiting
16
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Actively Recruiting
17
Michigan Institute of Urology
Troy, Michigan, United States, 48084
Actively Recruiting
18
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
19
Integrated Medical Professionals
North Hills, New York, United States, 11040
Actively Recruiting
20
Associated Medical Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
21
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
22
The Urology Group
Cincinnati, Ohio, United States, 45212
Actively Recruiting
23
Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
24
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
25
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
26
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
27
Lowcountry Urology Institute
Charleston, South Carolina, United States, 29406
Actively Recruiting
28
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
29
Urology Associates of Nashville
Nashville, Tennessee, United States, 37209
Actively Recruiting
30
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
31
Spokane Urology
Spokane, Washington, United States, 99202
Actively Recruiting
Research Team
M
Margaret Warner-Lubin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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