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Recruiting

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

NCT06134232 · Dendreon
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Official title
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
About this study
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 criteria
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 design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-02
Estimated completion: 2032-06-30
Last updated: 2025-08-27
Interventions
Drug: Sipuleucel-T Injection
Primary outcomes
  • Assess humoral immune response to PAP and PA2024 after booster infusion (Once all subjects have completed the study through the 5 year Overall Survival Period)
Sponsor
Dendreon · industry
With: WCG IRB, Talosix
Contacts & investigators
ContactMargaret Warner-Lubin · contact · ProvONE@dendreon.com · 2064588358
InvestigatorNadeem Sheikh, PhD · study_director, Dendreon Pharmaceuticals, LLC
InvestigatorBenjamin Lowentritt, MD · study_chair, Chesapeake Urology
All locations (31)
Arizona Urology SpecialistsRecruiting
Tuscon, Arizona, United States
City of Hope - National Medical CenterRecruiting
Duarte, California, United States
Urology Associates of Central California Medical GroupRecruiting
Fresno, California, United States
Unio Health Partners - Genesis Research, LLCRecruiting
San Diego, California, United States
Colorado UrologyRecruiting
Lakewood, Colorado, United States
Advanced Urology InstituteRecruiting
Daytona Beach, Florida, United States
Advanced Urology InstituteRecruiting
Largo, Florida, United States
Advanced Urology InstituteRecruiting
Ocala, Florida, United States
Florida Urology PartnersRecruiting
Riverview, Florida, United States
Associated Urological SpecialistsActive Not Recruiting
Chicago Ridge, Illinois, United States
UroPartnersRecruiting
Glenview, Illinois, United States
Advanced Urology AssociatesRecruiting
New Lenox, Illinois, United States
Urology of IndianaRecruiting
Carmel, Indiana, United States
First UrologyRecruiting
Jeffersonville, Indiana, United States
Urologic Specialists of Northwest IndianaRecruiting
Merrillville, Indiana, United States
Chesapeake Urology Research AssociatesRecruiting
Towson, Maryland, United States
Michigan Institute of UrologyRecruiting
Troy, Michigan, United States
Specialty Clinical Research of St. LouisRecruiting
St Louis, Missouri, United States
Integrated Medical ProfessionalsRecruiting
North Hills, New York, United States
Associated Medical Professionals of NYRecruiting
Syracuse, New York, United States
Associated Urologists of North CarolinaRecruiting
Raleigh, North Carolina, United States
The Urology GroupRecruiting
Cincinnati, Ohio, United States
Central Ohio Urology GroupRecruiting
Gahanna, Ohio, United States
Oregon Urology InstituteRecruiting
Springfield, Oregon, United States
MidLantic UrologyRecruiting
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology SpecialistsRecruiting
Lancaster, Pennsylvania, United States
Lowcountry Urology InstituteRecruiting
Charleston, South Carolina, United States
Carolina Urologic Research Center, LLCRecruiting
Myrtle Beach, South Carolina, United States
Urology Associates of NashvilleRecruiting
Nashville, Tennessee, United States
Urology of VirginiaRecruiting
Virginia Beach, Virginia, United States
Spokane UrologyRecruiting
Spokane, Washington, United States
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T · TrialPath