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Brief Title: Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer
Official Title: Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial
Study ID: NCT03921996
Brief Summary: For patients with intermediate-risk prostate cancer plus a predicted risk of \>5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.
Detailed Description: Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of \> 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and \> 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Kantonsspital Aarau AG, Aarau, , Switzerland
Universitätsspital Basel, Basel, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Hôpitaux Universitaires Genève, Genève, , Switzerland
Kantonsspital Baselland, Liestal, , Switzerland
Luzerner Kantonsspital, Luzern, , Switzerland
Spital Thurgau AG (Frauenfeld and Münsterlingen), Münsterlingen, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Stadtspital Triemli, Zürich, , Switzerland
Universitätsspital Zürich, Zürich, , Switzerland
Name: Cyrill A. Rentsch, MD-PhD
Affiliation: University Hospital Basel, Department of Urology
Role: STUDY_CHAIR