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Brief Title: Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
Official Title: A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)
Study ID: NCT04114825
Brief Summary: This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Tampa Bay Medical Research, Clearwater, Florida, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
GU Research Network/Urology Cancer Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai Hospitals, New York, New York, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
The Urology Place, San Antonio, Texas, United States
Gent University Hospital, Gent, , Belgium
CHU de Liège, Liège, , Belgium
Hôpital Erasme, Liège, , Belgium
Aalborg University, Departmen of Urology, Aalborg, , Denmark
Aarhus University Hospital, Department of Urology, Aarhus, , Denmark
Rigshospitalet, Copenhagen Prostate Cancer Center, Copenhagen, , Denmark
Herlev & Gentofte Hospital, Department of Urology, Herlev, , Denmark
Urinvejskirurgisk afdeling, Hospitalsenheden Vest, Holstebro, , Denmark
Odense University Hospital, Deparment of Urology, Odense, , Denmark
Meilahti Tower Hospital, Helsinki, , Finland
Oulu University Hospital, Oulu, , Finland
Seinajoki Central Hospital, Seinäjoki, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Hospital, Turku, , Finland
University Hospital Dresden, Dresden, , Germany
Urologicum Duisburg, Duisburg, , Germany
Urologische Praxis Dr. Wolfgang Warnack, Hagenow, , Germany
Urologische Praxis. M. Markov, Halle, , Germany
Studienpraxis Urologie, Nürtingen, , Germany
University Hospital Tuebingen, Tübingen, , Germany
Sahlgrenska University Hospital, Göteborg, , Sweden
Skåne University Hospital, Malmö, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Umeå University Hospital, Umeå, , Sweden
Örebro University Hospital, Örebro, , Sweden
Clatterbridge Centre for Oncology, Liverpool, , United Kingdom
Royal Free London NHS Foundation Trust Royal Free Hospital, London, , United Kingdom
Nottingham University Hospital, Nottingham, , United Kingdom
University Hospital Southampton, Southampton, , United Kingdom
Name: Klaus Brasso, MD
Affiliation: Rigshospitalet, Denmark
Role: PRINCIPAL_INVESTIGATOR