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Clinical Trials in the UK / NCT04114825
Active, not recruiting Phase 2

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

NCT04114825 · tracked via the Priya Life Science UK tracker
Sponsor
RhoVac APS
Phase
Phase 2
Started
2019-11-19
Last updated
2021-09-28

Condition(s) studied

Prostate Cancer Recurrent

Investigational drug(s) / intervention(s)

RV001VPlacebo

RV001V: RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).

Placebo: Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo

Study 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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Tampa Bay Medical Research Clearwater Florida
Chesapeake Urology Research Associates Towson Maryland
GU Research Network/Urology Cancer Center Omaha Nebraska
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Icahn School of Medicine at Mount Sinai Hospitals New York New York
Carolina Urologic Research Center Myrtle Beach South Carolina
The Urology Place San Antonio Texas
Gent University Hospital Ghent 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
Urinvejskirurgisk afdeling, Hospitalsenheden Vest Holstebro Denmark
Odense University Hospital, Deparment of Urology Odense Denmark
Meilahti Tower Hospital Helsinki Finland
Oulu University Hospital Oulu Finland
Seinajoki Central Hospital Seinäjoki Finland
Tampere University Hospital Tampere Finland
Turku University Hospital Turku Finland
University Hospital Dresden Dresden Germany
Urologicum Duisburg Duisburg Germany
Urologische Praxis Dr. Wolfgang Warnack Hagenow Germany
Urologische Praxis. M. Markov Halle Germany
Studienpraxis Urologie Nürtingen Germany
University Hospital Tuebingen Tübingen Germany
Sahlgrenska University Hospital Gothenburg Sweden
Skåne University Hospital Malmö Sweden
Örebro University Hospital Örebro Sweden
Karolinska University Hospital Stockholm Sweden
Umeå University Hospital Umeå 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04114825 on ClinicalTrials.gov ↗ ← All trials in the UK