Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
- Conditions
- Prostate Cancer Recurrent
- Interventions
- Biological: RV001VOther: Placebo
- Registration Number
- NCT04114825
- Lead Sponsor
- RhoVac APS
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 180
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RV001V 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). Placebo 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).
- Primary Outcome Measures
Name Time Method Time to PSA progression Up to 3 years 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.
- Secondary Outcome Measures
Name Time Method Proportion of patients showing a PSA response from baseline Up to 3 years Disease-free survival (DFS) Up to 3 years time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)
Safety by frequency and severity of adverse events (AEs) Up to 16 months The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized
Time to initiation of a subsequent antineoplastic therapy Up to 3 years
Trial Locations
- Locations (36)
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, 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
Gent University Hospital
🇧🇪Gent, 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
Meilahti Tower Hospital
🇫🇮Helsinki, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Seinajoki Central Hospital
🇫🇮Seinäjoki, Finland
University Hospital Dresden
🇩🇪Dresden, Germany
Turku University Hospital
🇫🇮Turku, Finland
Studienpraxis Urologie
🇩🇪Nürtingen, Germany
Tampere University Hospital
🇫🇮Tampere, Finland
Urologicum Duisburg
🇩🇪Duisburg, Germany
Urologische Praxis Dr. Wolfgang Warnack
🇩🇪Hagenow, Germany
Urologische Praxis. M. Markov
🇩🇪Halle, Germany
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Skåne University Hospital
🇸🇪Malmö, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
University Hospital Tuebingen
🇩🇪Tübingen, Germany
Umeå University Hospital
🇸🇪Umeå, Sweden
Örebro University Hospital
🇸🇪Örebro, 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
Urinvejskirurgisk afdeling, Hospitalsenheden Vest
🇩🇰Holstebro, Denmark
Odense University Hospital, Deparment of Urology
🇩🇰Odense, Denmark
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
GU Research Network/Urology Cancer Center
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
The Urology Place
🇺🇸San Antonio, Texas, United States