- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03921996
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Aarau, Switzerland, 5001
- Kantonsspital Aarau AG
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Basel, Switzerland, 4031
- Universitätsspital Basel
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Bern, Switzerland, 3010
- Inselspital, Bern
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Chur, Switzerland, 7000
- Kantonsspital Graubuenden
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Genève, Switzerland, 1211
- Hôpitaux Universitaires Genève
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Liestal, Switzerland, 4410
- Kantonsspital Baselland
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Luzern, Switzerland, 6000
- Luzerner Kantonsspital
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Münsterlingen, Switzerland, 8596
- Spital Thurgau AG (Frauenfeld and Münsterlingen)
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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Zürich, Switzerland, 8091
- Universitatsspital Zurich
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Zürich, Switzerland, 8063
- Stadtspital Triemli
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: arm A: ePLND
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
|
Active Comparator: arm B: no PLND
Radical prostatectomy only
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Radical prostatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate-specific antigen (PSA) persistence
Time Frame: From the date of surgery to 14 weeks after surgery
|
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 |
From the date of surgery to 14 weeks after surgery
|
Time to initiation of adjuvant or salvage therapies
Time Frame: 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 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.
|
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
Time Frame: From the date of randomization until the date of local or regional recurrence, assessed up to 15 years after surgery
|
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.
|
From the date of randomization until the date of local or regional recurrence, assessed up to 15 years after surgery
|
Time to distant metastasis
Time Frame: From the date of randomization until the date of first occurrence of distant metastasis, assessed up to 15 years after surgery
|
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.
|
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)
Time Frame: From the date of randomization until the date of death due to prostate cancer, assessed up to 15 years after surgery
|
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. |
From the date of randomization until the date of death due to prostate cancer, assessed up to 15 years after surgery
|
Overall survival (OS)
Time Frame: From the date of randomization until the date of death, assessed up to 15 years after surgery
|
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.
|
From the date of randomization until the date of death, assessed up to 15 years after surgery
|
Intraoperative complications
Time Frame: During surgery
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Intraoperative complications will be assessed using the CLASSIC system.
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During surgery
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Postoperative complications
Time Frame: From the date of surgery to 14 weeks after surgery
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Postoperative complications will be assessed using the Clavien-Dindo classification.
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From the date of surgery to 14 weeks after surgery
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Adverse events (AE)
Time Frame: From the date of registration to 15 years after surgery
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AEs will be assessed according to NCI CTCAE v5.0.
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From the date of registration to 15 years after surgery
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Collaborators and Investigators
Investigators
- Study Chair: Cyrill A. Rentsch, MD-PhD, University Hospital Basel, Department of Urology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAKK 09/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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