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

NCT04114825 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RhoVac-002
• Study Type: interventional
• Target: 180
• Locations: 7 countries
• Sites: 36

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).

Conditions

Prostate Cancer Recurrent

Keywords

Biochemical relapse

Outcome Measures

Primary Outcomes (1)

• Time to PSA progression

  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.

  Up to 3 years

Secondary Outcomes (4)

• Safety by frequency and severity of adverse events (AEs)

  Up to 16 months

• Time to initiation of a subsequent antineoplastic therapy

  Up to 3 years

• Proportion of patients showing a PSA response from baseline

  Up to 3 years

• Disease-free survival (DFS)

  Up to 3 years

Study Arms (2)

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).

Biological: RV001V

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).

Other: Placebo

Interventions

RV001V BIOLOGICAL

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

RV001V

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RhoVac APS: lead

Study Sites (36)

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

GU Research Network/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Icahn School of Medicine at Mount Sinai Hospitals

New York, New York, 10029, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

The Urology Place

San Antonio, Texas, 78240, United States

Location

Gent University Hospital

Ghent, Belgium

Location

CHU de Liège

Liège, Belgium

Location

Hôpital Erasme

Liège, Belgium

Location

Aalborg University, Departmen of Urology

Aalborg, 9000, Denmark

Location

Aarhus University Hospital, Department of Urology

Aarhus, 8000, Denmark

Location

Rigshospitalet, Copenhagen Prostate Cancer Center

Copenhagen, 2200, Denmark

Location

Herlev & Gentofte Hospital, Department of Urology

Herlev, 2730, Denmark

Location

Urinvejskirurgisk afdeling, Hospitalsenheden Vest

Holstebro, Denmark

Location

Odense University Hospital, Deparment of Urology

Odense, 5000, Denmark

Location

Meilahti Tower Hospital

Helsinki, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinajoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

University Hospital Dresden

Dresden, Germany

Location

Urologicum Duisburg

Duisburg, Germany

Location

Urologische Praxis Dr. Wolfgang Warnack

Hagenow, Germany

Location

Urologische Praxis. M. Markov

Halle, Germany

Location

Studienpraxis Urologie

Nürtingen, Germany

Location

University Hospital Tuebingen

Tübingen, Germany

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Clatterbridge Centre for Oncology

Liverpool, United Kingdom

Location

Royal Free London NHS Foundation Trust Royal Free Hospital

London, United Kingdom

Location

Nottingham University Hospital

Nottingham, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Study Officials

• Klaus Brasso, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2019
• First Posted: October 3, 2019
• Study Start: November 19, 2019
• Primary Completion: April 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

DK (6); GB (4); SE (5); US (7); FI (5); BE (3); DE (6)