Finding studies
Finding studies
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Lead
Universitaire Ziekenhuizen KU Leuven
PRIMARY OBJECTIVE: To assess the difference in antitumor effect between the treatment arms by measuring MRD following radical prostatectomy. SECONDARY OBJECTIVES: To measure differences between study arms in * Proportions of post neoadjuvant prostate specific antigen (PSA) ≤ 0.3 ng/ml as a predictor of prostate cancer mortality * T down-staging, complete pathological response, PSA kinetics, Testosterone kinetics, operation time, blood loss, grade of surgical difficulty * New generation hybrid imaging 68Ga PSMA (Prostate-Specific Membrane Antigen) PET/MR (Positron emission tomography/Magnetic Resonance) derived parameters * Early biochemical recurrence as prognostic factor of prostate cancer mortality * Transcriptome and genome * Tissue microarrays (TMA) protein expression (DNA repair, resistance etc.) by immunohistochemistry * Perioperative safety and tolerability * Quality of life, erection recovery, continence through validated preoperative and postoperative questionnaires pre and postop (IEEF5, ICIQ, EORTC QLQ-C30) OUTLINE: interventional, single center, phase II, randomized, double blind, placebo controlled trial.
Age
18–80
Sex
MALE
Healthy volunteers
Not accepted
