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Radical prostatectomy with extended pelvic lymph node dissection

ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

Radical prostatectomy (RP) followed by ePLND

Radical prostatectomy (RP) only

Cyrill A. Rentsch, MD-PhD

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.

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.

SAKK 09/18 is an international, multicenter, randomized, phase III surgical intervention trial

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

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

The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.

PSA persistence is defined as failure to reach a PSA value of \<0.1 ng/ml within 12 weeks (+ 2 weeks) postoperatively.

Patients with no assessments within the first 12 weeks (+ 2 weeks) after surgery will be counted as failures for this endpoint

Time to initiation of adjuvant or salvage therapies will be calculated as the time from randomization to the start of any type of adjuvant or salvage therapy. Patients not starting adjuvant or salvage therapies are censored at the last date they were known to be alive.

Time to loco-regional recurrence will be calculated from randomization until local (prostate bed) or regional (extent of ePLND template) recurrence, whichever occurs first. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage therapy, if any.

Time to distant metastasis will be calculated from randomization until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

PCSS will be calculated as the time from randomization to the date of death due to prostate cancer. Patients who died due to other reasons will be censored at the time of death. All other patients will be censored at the last date they were known to be alive.

Causes of death may require critical review by the coordinating investigator and the medical advisor. Particular attention will be paid to men who have been reported as having died from prostate cancer without previously reported progression or recurrence and men who were reported as having died from non-prostate cancer causes after developing biochemical or clinical progression.

OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Intraoperative complications will be assessed using the CLASSIC system.

Postoperative complications will be assessed using the Clavien-Dindo classification.

AEs will be assessed according to NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for radical prostatectomy (rp) only