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Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
Sponsor: RhoVac APS
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).
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)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2019-11-19
Completion Date
2022-11
Last Updated
2021-09-28
Healthy Volunteers
No
Conditions
Interventions
RV001V
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
Placebo
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
Locations (36)
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
Ghent, 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
Gothenburg, Sweden
Skåne University Hospital
Malmo, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University Hospital
Umeå, 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