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

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer Recurrent

• 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

Study Timeline

• Study First Submitted: 2019-09-28
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Study Start: 2019-11-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-04
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Tampa Bay Medical Research; 🇺🇸 Clearwater, Florida, United States

Chesapeake Urology Research Associates; 🇺🇸 Towson, Maryland, United States

GU Research Network/Urology Cancer Center; 🇺🇸 Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, 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

The Urology Place; 🇺🇸 San Antonio, Texas, United States

Gent University Hospital; 🇧🇪 Gent, Belgium

CHU de Liège; 🇧🇪 Liège, Belgium

Hôpital Erasme; 🇧🇪 Liège, Belgium

Scroll for more (26 remaining)