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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Swiss Group for Clinical Cancer Research
- Enrollment
- 57
- Locations
- 11
- Primary Endpoint
- Time to biochemical recurrence (BCR)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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-
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to biochemical recurrence (BCR)
Time Frame: From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery
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.
Secondary Outcomes
- 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)
- Overall survival (OS)(From the date of randomization until the date of death, assessed up to 15 years after surgery)
- Intraoperative complications(During surgery)
- Prostate-specific antigen (PSA) persistence(From the date of surgery to 14 weeks 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)
- Postoperative complications(From the date of surgery to 14 weeks after surgery)
- Adverse events (AE)(From the date of registration to 15 years after surgery)