What this study is
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
What's being tested
- Sipuleucel-T Injection
Intervention · DRUG
Single Infusion
Study details
- 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
- Sponsor
- Dendreon
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Enrolling
- 400 people
- Starts
- 2023-10-02
- Est. completion
- 2032-06-30
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (31)
30 openArizona Urology Specialists
Tuscon, Arizona, United States
- Kalpesh Patel, MD · Contact520 618 1010kpatel@arizonauro.com
RecruitingCity of Hope - National Medical Center
Duarte, California, United States
- Tanya Dorff Principal Investigator, MD · Contact626-218-6585mtuano@coh.org
RecruitingUrology Associates of Central California Medical Group
Fresno, California, United States
- William Schiff, MD · Contact559 321 2800drschiff@urologyassociates.net
RecruitingUnio Health Partners - Genesis Research, LLC
San Diego, California, United States
- Paul Dato, MD · Contact858 279 7050 ext. 2676Paul.Dato@UnioHP.com
RecruitingColorado Urology
Lakewood, Colorado, United States
- David Cahn, MD · Contact303-996-9649dcahn@coloradouro.com
RecruitingAdvanced Urology Institute
Daytona Beach, Florida, United States
- Evan Fynes, MD · Contact386 239 8500Evan.fynes@auihealth.com
RecruitingAdvanced Urology Institute
Largo, Florida, United States
- Matthew Truesdale, MD · Contact813 245 3782matthew.truesdale@auihealth.com
RecruitingAdvanced Urology Institute
Ocala, Florida, United States
- Edward King, MD · Contact352 430 0705edward.king@auihealth.com
RecruitingFlorida Urology Partners
Riverview, Florida, United States
- Alexander Engelman, MD · Contact813-981-3931aengelman@floridaurologypartners.com
RecruitingUroPartners
Glenview, Illinois, United States
- Jeffrey Pearl, MD · Contact847-823-3185jpearl@uropartners.com
RecruitingAdvanced Urology Associates
New Lenox, Illinois, United States
- Greg Andros, MD · Contact815 409 4930DrAndros@advuro.com
RecruitingUrology of Indiana
Carmel, Indiana, United States
- Kenneth Ney, MD · Contact317 564 5159kney@urologyin.com
RecruitingFirst Urology
Jeffersonville, Indiana, United States
- Ryan Malone, MD · Contact812-670-2755rmalone@1sturology.com
RecruitingUrologic Specialists of Northwest Indiana
Merrillville, Indiana, United States
- Manoj Rao, MD · Contact219 259 1291mrao@urologic-specialists.com
RecruitingChesapeake Urology Research Associates
Towson, Maryland, United States
- Ronald Tutrone, MD · Contact443 471 5741rtutrone@uniteduro.com
RecruitingMichigan Institute of Urology
Troy, Michigan, United States
- Jason Hafron, MD · Contact248 786 0467hafronj@michiganurology.com
RecruitingSpecialty Clinical Research of St. Louis
St Louis, Missouri, United States
- Brittany Minor · Contact314-806-3921brittany.minor@objective.health
RecruitingIntegrated Medical Professionals
North Hills, New York, United States
- Jed Kaminetsky, MD · Contact212 480 3333jkaminetsky@imppllc.com
RecruitingAssociated Medical Professionals of NY
Syracuse, New York, United States
- Christopher Pieczonka, MD · Contact315 558 6619cpieczonka@ampofny.com
RecruitingAssociated Urologists of North Carolina
Raleigh, North Carolina, United States
- Mark Jalkut, MD · Contact919 390 7368mjalkut@gmail.com
RecruitingThe Urology Group
Cincinnati, Ohio, United States
- Mark Pliskin, MD · Contact513 841 7550mpliskin@urologygroup.com
RecruitingCentral Ohio Urology Group
Gahanna, Ohio, United States
- Benjamin Martin, MD · Contact614 396 2684bmartin@centralohiourology.com
RecruitingOregon Urology Institute
Springfield, Oregon, United States
- Bryan Mehlhaff, MD · Contact541 284 5508bryan@oregonurology.com
RecruitingMidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
- Laurence Belkoff, MD · Contact610 667 0458lbelkoff@midlanticurology.com
RecruitingKeystone Urology Specialists
Lancaster, Pennsylvania, United States
- Paul Sieber, MD · Contact717 431 2285krisb@midlanticurology.com
RecruitingLowcountry Urology Institute
Charleston, South Carolina, United States
- Justin Ellett, MD · Contact843 572 1010jellett@lcurology.com
RecruitingCarolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
- Neal Shore, MD · Contact843-449-1010 ext. 5268kate.valipour@startresearch.com
RecruitingUrology Associates of Nashville
Nashville, Tennessee, United States
- David Morris, MD · Contact615-250-9268ctrotter@ua-pc.com
RecruitingUrology of Virginia
Virginia Beach, Virginia, United States
- Robert Given, MD · Contact757 452 3486abohannon@urologyofva.net
RecruitingSpokane Urology
Spokane, Washington, United States
- Raymond Lance, MD · Contact509 747 3147 ext. 112Amyb@spokaneurology.com
RecruitingAssociated Urological Specialists
Chicago Ridge, Illinois, United States
Active, not recruiting
Study team
Sponsor
Dendreon
Study ID P23-1
Study director
Nadeem Sheikh, PhD
Dendreon Pharmaceuticals, LLC
Study chair
Benjamin Lowentritt, MD
Chesapeake Urology
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.