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

Prostate Cancer Recurrent Clinical Trial

— BRaVac  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04114825
• Other study ID #: RhoVac-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 19, 2019
• Est. completion date: November 2022

Study information

• Verified date: September 2021
• Source: RhoVac APS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: November 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

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

Country	Name	City	State
Belgium	Gent University Hospital	Gent
Belgium	CHU de Liège	Liège
Belgium	Hôpital Erasme	Liège
Denmark	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
Finland	Meilahti Tower Hospital	Helsinki
Finland	Oulu University Hospital	Oulu
Finland	Seinajoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Germany	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
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Skåne University Hospital	Malmö
Sweden	Örebro University Hospital	Örebro
Sweden	Karolinska University Hospital	Stockholm
Sweden	Umeå University Hospital	Umeå
United Kingdom	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 States	Tampa Bay Medical Research	Clearwater	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Icahn School of Medicine at Mount Sinai Hospitals	New York	New York
United States	GU Research Network/Urology Cancer Center	Omaha	Nebraska
United States	The Urology Place	San Antonio	Texas
United States	Chesapeake Urology Research Associates	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
RhoVac APS

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Finland,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to initiation of a subsequent antineoplastic therapy		Up to 3 years
Secondary	Proportion of patients showing a PSA response from baseline		Up to 3 years
Secondary	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