Status:
ACTIVE_NOT_RECRUITING
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
Lead Sponsor:
RhoVac APS
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 pros...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04114825
Start Date
November 19 2019
End Date
November 1 2022
Last Update
September 28 2021
Active Locations (36)
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1
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
2
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
3
GU Research Network/Urology Cancer Center
Omaha, Nebraska, United States, 68130
4
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169