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

A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer Recurrent
• Intervention / Treatment: Biological: RV001V; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • Gent University Hospital
  • Liège, Belgium
    • CHU de Liège
  • Liège, Belgium
    • Hôpital Erasme
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University, Departmen of Urology
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital, Department of Urology
  • Copenhagen, Denmark, 2200
    • Rigshospitalet, Copenhagen Prostate Cancer Center
  • Herlev, Denmark, 2730
    • Herlev & Gentofte Hospital, Department of Urology
  • Holstebro, Denmark
    • Urinvejskirurgisk afdeling, Hospitalsenheden Vest
  • Odense, Denmark, 5000
    • Odense University Hospital, Deparment of Urology
• Finland
  • Helsinki, Finland
    • Meilahti Tower Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital
• Germany
  • Dresden, Germany
    • University Hospital Dresden
  • Duisburg, Germany
    • Urologicum Duisburg
  • Hagenow, Germany
    • Urologische Praxis Dr. Wolfgang Warnack
  • Halle, Germany
    • Urologische Praxis. M. Markov
  • Nürtingen, Germany
    • Studienpraxis Urologie
  • Tübingen, Germany
    • University Hospital Tuebingen
• Sweden
  • Göteborg, Sweden
    • Sahlgrenska University Hospital
  • Malmö, Sweden
    • Skåne University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Umeå, Sweden
    • Umea University Hospital
  • Örebro, Sweden
    • Örebro University Hospital
• United Kingdom
  • Liverpool, United Kingdom
    • Clatterbridge Centre for Oncology
  • London, United Kingdom
    • Royal Free London Nhs Foundation Trust Royal Free Hospital
  • Nottingham, United Kingdom
    • Nottingham University Hospital
  • Southampton, United Kingdom
    • University Hospital Southampton
• United States
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network/Urology Cancer Center
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai Hospitals
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • San Antonio, Texas, United States, 78240
      • The Urology Place

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Main Inclusion Criteria:

• Biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis by standard CT imaging and bone scintigraphy, or locoregional recurrence (including lymph nodes) assessed by CT or multi-parametric magnetic resonance imaging (MRI) and confirmed with negative biopsy in case of prior RT.
• In case of BCR after RP all the following criteria should apply: a. PSA ≥0.2 ng/mL, b. PSA Doubling Time (PSADT) >3 months and <12 months
• In case of BCR after RT all the following criteria should apply: a. PSA >nadir + 2 ng/mL, b. PSADT >3 months and <12 months
• ECOG performance status ≤2.
• Laboratory values obtained ≤30 days prior to first vaccination: Hemoglobin ≥5.6 mmol/L; Absolute granulocyte count ≥1.5 x 109 /L, Platelets ≥100 x 109 /L., Total bilirubin ≤1.5 x upper limit of normal (ULN).
• Creatinine ≤1.5 x ULN.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5 x ULN.

Main Exclusion Criteria:

• Patients who are receiving androgen-deprivation therapy or considered a candidate for immediate anti-androgen deprivation therapy (ADT) as judged by the investigator.
• Patients who have received prior ADT are not eligible with the exception of those that received ADT ≤36 months in duration and ≥9 months before randomization and administered only in the neoadjuvant/adjuvant setting.
• Patient is planned for salvage therapy with RT or radical prostatectomy.
• Castrate level of serum testosterone <50 ng/dL at screening.
• PSA >10 ng/mL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RV001V; Total of 12 SC vaccinations with RV001V. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).	Biological: RV001V; RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
Placebo Comparator: Placebo; Total of 12 SC vaccinations with placebo. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).	Other: Placebo; Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to PSA progression	Time to PSA progression is defined as the time from randomization to doubling of PSA from the baseline value. The time to doubling will be estimated from a log-linear regression of PSA values.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety by frequency and severity of adverse events (AEs)	The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized	Up to 16 months
Time to initiation of a subsequent antineoplastic therapy		Up to 3 years
Proportion of patients showing a PSA response from baseline		Up to 3 years
Disease-free survival (DFS)	time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)	Up to 3 years

Collaborators and Investigators

• Sponsor: RhoVac APS
• Investigators: Principal Investigator: Klaus Brasso, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 28, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Biochemical relapse
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RhoVac-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No