Clinical Trials /

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

NCT04114825

Description:

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).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: RhoVac-002
  • NCT ID: NCT04114825

Conditions

  • Prostate Cancer Recurrent

Interventions

DrugSynonymsArms
RV001VRV001V

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
RV001VExperimentalTotal 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).
  • RV001V
PlaceboPlacebo ComparatorTotal 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).

    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, c. History of Gleason 7 (4 + 3) or
                 higher.
    
              -  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, c.History of Gleason score of 7 (4 + 3) or
                 higher
    
              -  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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Time to PSA progression
    Time Frame:Up to 3 years
    Safety Issue:
    Description: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

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

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:RhoVac APS

    Trial Keywords

    • Biochemical relapse

    Last Updated

    August 25, 2020