Prostate Cancer RecurrentPhase 2BRaVacNCT04114825
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
A Phase 2 study testing RV001V in people with Prostate Cancer Recurrent, run by RhoVac APS at 36 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- RV001V
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 19 Nov 2019to Nov 2022
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
United States7 sites
Tampa Bay Medical Research
Clearwater, Florida, 33761
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Icahn School of Medicine at Mount Sinai Hospitals
New York, New York, 10029
GU Research Network/Urology Cancer Center
Omaha, Nebraska, 68130
The Urology Place
San Antonio, Texas, 78240
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Denmark6 sites
Aalborg University, Departmen of Urology
Aalborg, 9000
Aarhus University Hospital, Department of Urology
Aarhus, 8000
Rigshospitalet, Copenhagen Prostate Cancer Center
Copenhagen, 2200
Herlev & Gentofte Hospital, Department of Urology
Herlev, 2730
Urinvejskirurgisk afdeling, Hospitalsenheden Vest
Holstebro
Odense University Hospital, Deparment of Urology
Odense, 5000
Germany6 sites
University Hospital Dresden
Dresden
Urologicum Duisburg
Duisburg
Urologische Praxis Dr. Wolfgang Warnack
Hagenow
Urologische Praxis. M. Markov
Halle
Studienpraxis Urologie
Nürtingen
University Hospital Tuebingen
Tübingen
Finland5 sites
Meilahti Tower Hospital
Helsinki
Oulu University Hospital
Oulu
Seinajoki Central Hospital
Seinäjoki
Tampere University Hospital
Tampere
Turku University Hospital
Turku
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg
Skåne University Hospital
Malmö
Örebro University Hospital
Örebro
Karolinska University Hospital
Stockholm
Umeå University Hospital
Umeå
United Kingdom4 sites
Clatterbridge Centre for Oncology
Liverpool
Royal Free London NHS Foundation Trust Royal Free Hospital
London
Nottingham University Hospital
Nottingham
University Hospital Southampton
Southampton
Belgium3 sites
Gent University Hospital
Ghent
CHU de Liège
Liège
Hôpital Erasme
Liège
About this study
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)
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
- Being tested
- RV001V, Placebo
- Keywords
- Biochemical relapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV001VBiological
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
PlaceboOther
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (4)
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
Measured: Up to 16 months
Time to initiation of a subsequent antineoplastic therapy
Measured: Up to 3 years
Proportion of patients showing a PSA response from baseline
Measured: Up to 3 years
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)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start19 Nov 2019
- Primary completionApr 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RhoVac APS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Brasso, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114825
- Sponsor's protocol ID
- RhoVac-002
- Acronym
- BRaVac
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04114825
- Acronym / sponsor ID
- BRaVac / RhoVac-002
- Conditions
- Prostate Cancer Recurrent
- Keywords
- Biochemical relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- RhoVac APSIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV001V | Experimental | Biological: RV001VTotal 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). |
| Placebo | Placebo comparator | Other: PlaceboTotal 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV001VRV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V). | Biological | RV001V |
| PlaceboPlacebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo | Other | Placebo |
Primary outcome
Time to PSA progression
Time frame: 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.
4 secondary outcomes
Safety by frequency and severity of adverse events (AEs)
Time frame: Up to 16 months
Time to initiation of a subsequent antineoplastic therapy
Time frame: Up to 3 years
Proportion of patients showing a PSA response from baseline
Time frame: Up to 3 years
Disease-free survival (DFS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Brasso, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RV001V in people with Prostate Cancer Recurrent, run by RhoVac APS at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Denmark, Germany, Finland, Sweden and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to PSA progression (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.