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NCT04114825 · ClinicalTrials.gov registry record · Phase 2
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
A Phase 2 study of Prostate Cancer Recurrent, sponsored by RhoVac APS.
- Active
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT04114825: Active Phase 2 study of Prostate Cancer Recurrent, sponsored by RhoVac APS.
NCT04114825 is a Phase 2 study of Prostate Cancer Recurrent that is active but no longer recruiting, run by RhoVac APS. The registered enrollment target is 180 participants, above the 105-participant average among 6 other Prostate Cancer Recurrent trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04114825, a Phase 2 study of Prostate Cancer Recurrent, is active but no longer recruiting, sponsored by RhoVac APS.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL RV001V
Study Locations (20)
Other
- Gent University Hospital - Ghent
- CHU de Liège - Liège
- Hôpital Erasme - Liège
- Aalborg University, Departmen of Urology - Aalborg
- Aarhus University Hospital, Department of Urology - Aarhus
- Rigshospitalet, Copenhagen Prostate Cancer Center - Copenhagen
- Herlev & Gentofte Hospital, Department of Urology - Herlev
- Urinvejskirurgisk afdeling, Hospitalsenheden Vest - Holstebro
- Odense University Hospital, Deparment of Urology - Odense
- Meilahti Tower Hospital - Helsinki
- Oulu University Hospital - Oulu
- Seinajoki Central Hospital - Seinäjoki
- Tampere University Hospital - Tampere
Florida
- Tampa Bay Medical Research - Clearwater
Maryland
- Chesapeake Urology Research Associates - Towson
Nebraska
- GU Research Network/Urology Cancer Center - Omaha
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
New York
- Icahn School of Medicine at Mount Sinai Hospitals - New York
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
Texas
- The Urology Place - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2022-11 |
| Phase | Phase 2 |
What the registry record for NCT04114825 still lists
NCT04114825 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 105-participant average among 6 other Prostate Cancer Recurrent trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Prostate Cancer Recurrent appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04114825 names 20 study sites across 8 states, led by Other, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT04114825 about?
NCT04114825 is a clinical study titled "Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer". 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...
What is the current status of trial NCT04114825?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2019-11-19. Estimated completion is 2022-11.
What conditions does trial NCT04114825 study?
This clinical trial studies the following conditions: Prostate Cancer Recurrent.
What interventions are being tested in trial NCT04114825?
The interventions under investigation include: Placebo (OTHER), RV001V (BIOLOGICAL).
Who is sponsoring clinical trial NCT04114825?
This trial is sponsored by RhoVac APS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04114825 being conducted?
This trial has 20 study locations across Florida, Maryland, Nebraska, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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