Back to resultsStudy of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)
Primary Purpose
Prostate Cancer Recurrent
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RV001V
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer Recurrent focused on measuring Biochemical relapse
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
Sites / Locations
- Tampa Bay Medical Research
- Chesapeake Urology Research Associates
- GU Research Network/Urology Cancer Center
- Comprehensive Cancer Centers of Nevada
- Icahn School of Medicine at Mount Sinai Hospitals
- Carolina Urologic Research Center
- The Urology Place
- Gent University Hospital
- CHU de Liège
- Hôpital Erasme
- Aalborg University, Departmen of Urology
- Aarhus University Hospital, Department of Urology
- Rigshospitalet, Copenhagen Prostate Cancer Center
- Herlev & Gentofte Hospital, Department of Urology
- Urinvejskirurgisk afdeling, Hospitalsenheden Vest
- Odense University Hospital, Deparment of Urology
- Meilahti Tower Hospital
- Oulu University Hospital
- Seinajoki Central Hospital
- Tampere University Hospital
- Turku University Hospital
- University Hospital Dresden
- Urologicum Duisburg
- Urologische Praxis Dr. Wolfgang Warnack
- Urologische Praxis. M. Markov
- Studienpraxis Urologie
- University Hospital Tuebingen
- Sahlgrenska University Hospital
- Skåne University Hospital
- Karolinska University Hospital
- Umeå University Hospital
- Örebro University Hospital
- Clatterbridge Centre for Oncology
- Royal Free London NHS Foundation Trust Royal Free Hospital
- Nottingham University Hospital
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RV001V
Placebo
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety by frequency and severity of adverse events (AEs)
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
Proportion of patients showing a PSA response from baseline
Disease-free survival (DFS)
time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04114825
Brief Title
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
Acronym
BRaVac
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RhoVac APS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Recurrent
Keywords
Biochemical relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RV001V
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
RV001V
Intervention Description
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
Primary Outcome Measure Information:
Title
Time to PSA progression
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Safety by frequency and severity of adverse events (AEs)
Description
The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized
Time Frame
Up to 16 months
Title
Time to initiation of a subsequent antineoplastic therapy
Time Frame
Up to 3 years
Title
Proportion of patients showing a PSA response from baseline
Time Frame
Up to 3 years
Title
Disease-free survival (DFS)
Description
time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Brasso, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
GU Research Network/Urology Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai Hospitals
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
The Urology Place
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Gent University Hospital
City
Gent
Country
Belgium
Facility Name
CHU de Liège
City
Liège
Country
Belgium
Facility Name
Hôpital Erasme
City
Liège
Country
Belgium
Facility Name
Aalborg University, Departmen of Urology
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital, Department of Urology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigshospitalet, Copenhagen Prostate Cancer Center
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Herlev & Gentofte Hospital, Department of Urology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Urinvejskirurgisk afdeling, Hospitalsenheden Vest
City
Holstebro
Country
Denmark
Facility Name
Odense University Hospital, Deparment of Urology
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Meilahti Tower Hospital
City
Helsinki
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinajoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
University Hospital Dresden
City
Dresden
Country
Germany
Facility Name
Urologicum Duisburg
City
Duisburg
Country
Germany
Facility Name
Urologische Praxis Dr. Wolfgang Warnack
City
Hagenow
Country
Germany
Facility Name
Urologische Praxis. M. Markov
City
Halle
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nürtingen
Country
Germany
Facility Name
University Hospital Tuebingen
City
Tübingen
Country
Germany
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
Skåne University Hospital
City
Malmö
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Umeå University Hospital
City
Umeå
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Facility Name
Clatterbridge Centre for Oncology
City
Liverpool
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
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