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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
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.
Time frame: Up to 3 years
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 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 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
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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
...and 26 more locations