Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
RhoVac APS
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Patients who are receiving androgen-deprivation therapy or considered a candidate for immediate anti-androgen deprivation therapy (ADT) as judged by the investigator.
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
Clareo Health | Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
