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

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ClinicalTrials.gov Identifier: NCT04114825
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Biological: RV001V Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Time to PSA progression [ Time Frame: 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 :
  1. Safety by frequency and severity of adverse events (AEs) [ Time Frame: Up to 16 months ]
    The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized

  2. Time to initiation of a subsequent antineoplastic therapy [ Time Frame: Up to 3 years ]
  3. Proportion of patients showing a PSA response from baseline [ Time Frame: Up to 3 years ]
  4. Disease-free survival (DFS) [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114825


Contacts
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Contact: Steven Glazer, MD +45 25674434 sgl@rhovac.com
Contact: Malene Weis, PharmD +45 53542818 mw@rhovac.com

Locations
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Denmark
Aalborg University, Departmen of Urology Recruiting
Aalborg, Denmark, 9000
Contact: Niels Christian Langkilde, MD         
Aarhus University Hospital, Department of Urology Recruiting
Aarhus, Denmark, 8000
Contact: Michael Borre, MD         
Rigshospitalet, Copenhagen Prostate Cancer Center Recruiting
Copenhagen, Denmark, 2200
Contact: Klaus Brasso, MD         
Herlev & Gentofte Hospital, Department of Urology Recruiting
Herlev, Denmark, 2730
Contact: Lisa Andersen, MD         
Odense University Hospital, Deparment of Urology Recruiting
Odense, Denmark, 5000
Contact: Mads Hvid Aaberg Poulsen, MD         
Sponsors and Collaborators
RhoVac APS
Investigators
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Principal Investigator: Klaus Brasso, MD Rigshospitalet, Denmark

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Responsible Party: RhoVac APS
ClinicalTrials.gov Identifier: NCT04114825     History of Changes
Other Study ID Numbers: RhoVac-002
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RhoVac APS:
Biochemical relapse
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases