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

NCT ID: NCT03921996

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-27
• Study Completion Date: 2021-11-11

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm A: ePLND

Radical prostatectomy with extended pelvic lymph node dissection

Group Type: EXPERIMENTAL

Radical prostatectomy (RP) followed by ePLND

Intervention Type: PROCEDURE

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

arm B: no PLND

Radical prostatectomy only

Group Type: ACTIVE_COMPARATOR

Radical prostatectomy (RP) only

Intervention Type: PROCEDURE

Radical prostatectomy

Interventions

Radical prostatectomy (RP) followed by ePLND

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

Intervention Type: PROCEDURE

Radical prostatectomy (RP) only

Radical prostatectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures.
• Histologically proven localized adenocarcinoma of the prostate.
• High-risk prostate cancer or intermediate-risk prostate cancer defined by D'Amico classification system, with an estimated risk of >5% of lymph node metastasis.
• Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
• Age ≥ 18 years and ≤ 80 years.
• WHO performance status 0-1.
• Adequate condition (ASA ≤ III) for general anesthesia and radical prostatectomy surgery.
• Baseline Quality of Life (QoL) questionnaires have been completed.

Exclusion Criteria

• Any pre-operative evidence for T4 disease.
• Metastatic prostate cancer according to staging or evidence of lymph node metastasis by imaging, defined as any pelvic lymph node >9 mm in the short axis or positive lymph nodes detected by imaging techniques with sensitivities similar or better than PSMA-PET or Choline-PET prior to surgery.
• PSA ≥ 50 ng/ml.
• Any prior neo-adjuvant, local or systemic treatment for prostate cancer (alpha reductase inhibitors for treatment of benign hyperplasia are allowed)
• Previous pelvic lymph node dissection.
• Any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyrill A. Rentsch, MD-PhD

Role: STUDY_CHAIR

University Hospital Basel, Department of Urology

Locations

Kantonsspital Aarau AG

Aarau, , Switzerland

Universitätsspital Basel

Basel, , Switzerland

Inselspital, Bern

Bern, , Switzerland

Kantonsspital Graubuenden

Chur, , Switzerland

Hôpitaux Universitaires Genève

Geneva, , Switzerland

Kantonsspital Baselland

Liestal, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Spital Thurgau AG (Frauenfeld and Münsterlingen)

Münsterlingen, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Stadtspital Triemli

Zurich, , Switzerland

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

SAKK 09/18

Identifier Type: -

Identifier Source: org_study_id