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

NCT03921996 | Terminated Phase 3 DMC

• 1 other identifier: SAKK 09/18
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 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.

Conditions

Prostate Cancer

Keywords

Extended pelvic lymph node dissection; Pelvic lymph node dissection; ePLND; Prostate Cancer; intermediate prostate cancer; High-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to biochemical recurrence (BCR)

  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.

  From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery

Secondary Outcomes (9)

• Prostate-specific antigen (PSA) persistence

  From the date of surgery to 14 weeks after surgery

• Time to initiation of adjuvant or salvage therapies

  From the date of randomization until the date of start of any type of adjuvant or salvage therapy, assessed up to 15 years after surgery

• Time to loco-regional recurrence

  From the date of randomization until the date of local or regional recurrence, assessed up to 15 years after surgery

• Time to distant metastasis

  From the date of randomization until the date of first occurrence of distant metastasis, assessed up to 15 years after surgery

• Prostate cancer-specific survival (PCSS)

  From the date of randomization until the date of death due to prostate cancer, assessed up to 15 years after surgery

Study Arms (2)

arm A: ePLND

EXPERIMENTAL

Radical prostatectomy with extended pelvic lymph node dissection

Procedure: Radical prostatectomy (RP) followed by ePLND

arm B: no PLND

ACTIVE COMPARATOR

Radical prostatectomy only

Procedure: Radical prostatectomy (RP) only

Interventions

Radical prostatectomy (RP) followed by ePLND PROCEDURE

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

arm A: ePLND

Radical prostatectomy (RP) only PROCEDURE

Radical prostatectomy

arm B: no PLND

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (11)

Kantonsspital Aarau AG

Aarau, 5001, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Inselspital, Bern

Bern, 3010, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hôpitaux Universitaires Genève

Geneva, 1211, Switzerland

Location

Kantonsspital Baselland

Liestal, 4410, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Spital Thurgau AG (Frauenfeld and Münsterlingen)

Münsterlingen, 8596, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Single Person

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Cyrill A. Rentsch, MD-PhD

  University Hospital Basel, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 19, 2019
• Study Start: August 27, 2019
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

CH (11)