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ACTIVE NOT RECRUITING
NCT04114825
PHASE2

Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

Sponsor: RhoVac APS

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

RV001V

RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).

OTHER

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