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).
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
Drug | Synonyms | Arms |
---|
RV001V | | RV001V |
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
Name | Type | Description | Interventions |
---|
RV001V | Experimental | 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 Comparator | 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). | |
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.
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
Last Updated
March 2, 2021