A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)
Prostate Cancer Metastatic

About this trial
This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring PROSTVAC, metastatic, prostate cancer, castrate-resistant, vaccine, immunotherapy, Phase 3
Eligibility Criteria
Inclusion Criteria:
Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
OR
- PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
Exclusion Criteria:
Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
Sites / Locations
- Alaska Clinical Research Center, Llc
- Scottsdale Healthcare
- Alta Bates Summit Medical Center
- Cedars-Sinai Medical Center
- Prostate Oncology Specialists, Inc.
- Desert Hematology-Oncology
- San Bernardino Urological Associates
- San Diego Clinical Trials
- Sharp Memorial Hospital
- VA San Diego Healthcare System
- Stanford Advanced Medical Center
- University of Colorado
- The Urology Center of Colorado
- Washington Cancer Institute
- South Florida Medical Research
- Manatee Medical Research Institute, LLC
- Florida Urology Physicians
- Lakeland Regional Cancer Center
- Pinellas Urology, Inc.
- James A Haley Veteran Affairs Medical Center
- Palm Beach Cancer Institute
- North Idaho Urology
- Jesse Brown VA
- First Urology PSC
- Northern Indiana Cancer Research Consortium
- The Iowa Clinic, PC Iowa Urology
- Tulane University
- Ochsner Cancer Institute
- Maryland Prostate Center
- Greater Baltimore Medical Center
- Union Memorial Hospital
- Walter Reed Army Medical Center
- National Cancer Institute - Center for Cancer Research
- Myron Murdock M.D. LLC
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Mayo Clinic
- Kansas City VA Medical Center
- GU Research Network, LLC
- Nebraska Cancer Specialists
- Comprehensive Cancer Centers of Nevada
- VA Sierra Nevada HealthCare System
- Delaware Valley Urology LLC - Westhampton
- The Cancer Institute of New Jersey
- Brooklyn Urology Research Group
- University Urology Associates
- Hudson Valley Urology, P.C.
- Presbyterian Hospital Center for Cancer Research
- Northeast Urology Research
- Regional Cancer Care PA
- Durham VA Medical Center
- W.G. (Bill) Hefner VA Medical Center
- St. Alexius Medical Center
- Gabrail Cancer Center
- University of Cincinnati Medical Center
- University Hospitals Case Medical Center
- Cleveland Clinic Foundation
- Columbus Urology Research
- Willamette Valley Cancer Center
- Urologic Consultants of Southeaster PA LLP
- Urological Associates Of Lancaster
- Fox Chase Cancer Center
- UPMC Cancer Pavillion
- Mount Nittany Medical Center
- Ralph H Johnson VAMC
- WJB Dorn VA Medical Center
- Greenville Hospital System
- Carolina Urologic Research Center
- University of TN Medical Center
- The West Clinic, P.C.
- James H. Quillen Veterans Affairs Medical Center
- Urology Associates, PC
- Urology Clinics of North Texas
- Mary Crowley Cancer Research Center
- Central Texas Veterans Health Care System
- Scott and White Memorial Hospital
- Salt Lake Research
- University of Utah
- White River Junction Veterans Affairs Medical Center
- Virginia Oncology Associates PC
- Virginia Mason Medical Center
- Madigan Army Medical Center
- The Schiffler Cancer Center
- Medical College of Wisconsin
- Sydney Haematology and Oncology Clinic
- Calvary Mater Newcastle
- Redcliffe Hospital
- Royal Adelaide Hospital
- Austin Hospital
- Monash Medical Centre - Moorabbin Campus
- Barwon Health
- St John of God Hospital
- Border Medical Oncology
- Princess Alexandra Hospital
- Ziekenhuisnetwerk Antwerpen - AZ Middelheim
- Cliniques Universitaires Saint-Luc
- Institut Jules Bordet
- AZ Maria Middelares
- UZ Leuven
- H.-Hartziekenhuis Roeselare-Menen vzw
- Southern Interior Medical Research Inc.
- Capital District Health Authority
- Brantford Urology Research
- Cambridge Memorial Hospital
- St. Josephs Healthcare Hamilton Research Ethics Board
- Queen's University at Kingston
- London Health Sciences Centre
- The Female/Male Health Centres
- Princess Margaret Hospital
- Centre Hospitalier de l'Universite de Montreal
- Centre Hospitalier Universitaire de Quebec Hotel Dieu
- Aalborg Sygehus
- Rigshospitalet
- Frederiksberg Hospital
- Herlev Hospital
- Holstebro Sygehus
- Storstrømmens Sygehus Næstved
- Skejby Sygehus
- East Tallinn Central Hospital
- North Estonia Medical Centre Foundation
- Tartu University Hospital
- Centre Paul Papin
- Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
- Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
- Centre d'Oncologie de Gentilly
- HIA du Val de Grâce
- Institut Curie
- Fondation Hôpital Saint-Joseph
- Institut Mutualiste Montsouris
- Centre Hospitalier Lyon Sud
- Institut Jean Godinot - Centre de lutte contre le cancer
- Clinique Armoricaine de Radiologie
- Hôpital Bretonneau
- Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine
- Stadtisches Klinikum Muchen GmbH
- Universitätsklinikum Bonn
- Universitätsklinikum Essen
- Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
- Chirurgische Universitätsklinik Freiburg
- Martini-Klinik am UKE GmbH
- Klinikum der Friedrich-Schiller-Universität Jena
- Universitätsmedizin der JGU Mainz
- Klinikum der Philipps-Universität Marburg
- Studienpraxis Urologie
- Universitätsklinikum Tübingen
- Universitatsklinikum Ulm
- Universitätsklinikum Ulm
- Universitätsklinikum Würzburg
- Landspitali University Hospital
- Soroka University Medical Center
- Bnei Zion Medical Center
- Rambam Medical Center
- Edith Wolfson Medical Center
- Hadassah University Hospital Ein Kerem
- The Chaim Sheba Medical Center
- Assaf Harofe Medical Center
- NKI-AVL
- VUMC
- Academisch Ziekenhuis Maastricht
- Radboudumc
- Erasmus MC
- AMEDS CENTRUM Sp. z o.o.
- Urologica Praktyka Lekarska Adam Marcheluk
- Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.
- Miedzyleski Szpital Specjalistyczny w Warszawie
- Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu
- Ponce School of Medicine
- Alliance for Research and Knowledge
- Arkhangelsk Regional Clinical Oncology Dispensary
- Chelyabinsk Regional Clinical Oncology Dispensary
- Kazan State Medical University
- Moscow Research Oncology Institute n.a. P.A.Gertsen
- Clinical Oncology Dispensary
- Orel Oncology Center
- Orenburg Regional Clinical Oncology Center
- St. Petersburg Medical Academy of Postgraduate Education
- St. Petersburg State Medical University n.a. I.P. Pavlov
- City Hospital #15
- "Orkli" LLC
- "Clinic Andros" LLC
- Stavropol Regional Clinical Oncology Dispensary
- Regional Clinical Oncology Center
- Regional Clinical Oncology Hospital
- Hospital Clinico Universitario de Santiago de Compostela
- Hospital 12 de Octubre
- Clinica Universitaria de Navarra
- Hospital Nuestra Señora de Sonsoles
- Hospital del Mar
- Hospital Vall D´Hebron
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Reina Sofia
- Hospital General Universitario de Elche
- Hospital General Universitario Gregorio Marañon
- MD Anderson International Espana
- Centro Integral Oncológico Clara Campal
- Hospital Universitario Fundación Alcorcón
- Hospital Universitario Puerta de Hierro
- Althaia: Xarxa Assistencial de Manresa
- Hospital General Carlos Haya
- Hospital Son Espases
- Fundación Hospital Manacor
- Clinica Universitaria de Navarra
- Corporació Sanitaria Parc Taulí
- Hospital Virgen del Rocio
- Hospital Mutua de Terrassa
- Hospital Universitario Miguel Servet
- Bristol Haematology & Oncology Centre
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
- Velindre Hospital
- Beatson West of Scotland Cancer Centre
- University of Surrey
- Leeds Teaching Hospitals NHS Trust, St James's University Hospital
- St Bartholomews Hospital
- The Royal Marsden
- St Mary's Hospital
- Christie Hospital
- Plymouth Hospitals NHS Trust, Derriford Hospital
- University of Southampton
- Royal Marsden Hospital
- The Clatterbridge Cancer Centre NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
PROSTVAC-V/F-TRICOM + GM-CSF
PROSTVAC-V/F-TRICOM + GM-CSF placebo
Placebo Control
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF
PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF placebo
PROSTVAC V/F Placebo + GM-CSF Placebo