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Spots Global Cancer Trial Database for Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

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Trial Identification

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

Conditions

Prostate Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Cyrill A. Rentsch, MD-PhD

Affiliation: University Hospital Basel, Department of Urology

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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