Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
NCT ID: NCT04114825
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2019-11-19
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
RV001V
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
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).
Placebo
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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RhoVac APS
INDUSTRY
Responsible Party
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Principal Investigators
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Klaus Brasso, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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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
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
Malmo, , 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
Countries
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Other Identifiers
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RhoVac-002
Identifier Type: -
Identifier Source: org_study_id
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