Clinical trial NCT04114825: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Recurrent
Keywords: Biochemical relapse
Lead sponsor: RhoVac APS
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Time to PSA progression
timeFrame: Up to 3 years
Secondary outcomes:
measure: Safety by frequency and severity of adverse events (AEs)
timeFrame: Up to 16 months
measure: Time to initiation of a subsequent antineoplastic therapy
timeFrame: Up to 3 years
measure: Proportion of patients showing a PSA response from baseline
timeFrame: Up to 3 years
measure: Disease-free survival (DFS)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Omaha
country: United States
facility: GU Research Network/Urology Cancer Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Hospitals
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Gent
country: Belgium
facility: Gent University Hospital
city: Liège
country: Belgium
facility: CHU de Liège
city: Liège
country: Belgium
facility: Hôpital Erasme
city: Aalborg
country: Denmark
facility: Aalborg University, Departmen of Urology
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Urology
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen Prostate Cancer Center
city: Herlev
country: Denmark
facility: Herlev & Gentofte Hospital, Department of Urology
city: Holstebro
country: Denmark
facility: Urinvejskirurgisk afdeling, Hospitalsenheden Vest
city: Odense
country: Denmark
facility: Odense University Hospital, Deparment of Urology
city: Helsinki
country: Finland
facility: Meilahti Tower Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinajoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Hagenow
country: Germany
facility: Urologische Praxis Dr. Wolfgang Warnack
city: Halle
country: Germany
facility: Urologische Praxis. M. Markov
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
city: Tübingen
country: Germany
facility: University Hospital Tuebingen
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
city: Liverpool
country: United Kingdom
facility: Clatterbridge Centre for Oncology
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust Royal Free Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Rigshospitalet, Denmark
name: Klaus Brasso, MD
role: PRINCIPAL_INVESTIGATOR
References: