Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no / limited lymph node dissection | Experimental |
| |
| limited / extended lymph node dissection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical prostatectomy with extended / limited lymph node dissection | Procedure | In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with extended lymph node dissection (incl. external iliac, obturator, internal iliac and common iliac nodes up to ureter bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis-free survival | time from randomization to first diagnosis of distant metastasis from prostate cancer | from enrollment to the end of the study at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day complication rate | rate of complications from the start of surgery to 30 days postoperatively graded by Clavien-Dindo | from the start of surgery to 30 days postoperatively |
| Perioperative events (length of surgery, intraoperative blood loss) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Alexandrov National Cancer Centre | Recruiting | Lyasny | Minsk Oblast | 223040 | Belarus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radical prostatectomy with limited / no lymph node dissection | Procedure | In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with no lymph nodes dissection bilaterally. |
|
| perioperatively |
| Duration of hospital stay | time from surgery to the discharge from the hospital | at first follow up visit (6-12 weeks post-surgery) |
| Biochemical recurrence-free survival | time from randomization to first confirmed PSA rise > / = 0.2 ng/ml | from enrollment to the end of the study at 5 years |
| Time to treatment | time from randomization to the first prostate cancer-related therapy | from enrollment to the end of the study at 5 years |
| Prostate cancer specific survival | time from randomization to death from prostate cancer | from enrollment to the end of the study at 5-7 years |
| Overall survival | time from randomization to to death of any cause | from enrollment to the end of the study at 5-7 years |
| Metastasis-free survival in subgroups of patients (NCCN risk groups, operated by individual surgeon) | time from randomization to first diagnosis of distant metastasis from prostate cancer | from enrollment to the end of the study at 5 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided