Prostate Cancer Recurrent
Conditions
Keywords
Biochemical relapse
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).
Interventions
BIOLOGICALRV001V
RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
OTHERPlacebo
Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
Sponsors
RhoVac APS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to PSA progression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety by frequency and severity of adverse events (AEs) | Up to 16 months | 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 | 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 | time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU) |
Countries
Belgium, Denmark, Finland, Germany, Sweden, United Kingdom, United States
Outcome results
None listed