Prostate Cancer Patients Undergoing Radical Prostatectomy
Conditions
Keywords
prostate cancer, lymph node dissection, radical prostatectomy
Brief summary
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.
Interventions
PROCEDURERadical prostatectomy with extended / limited lymph node dissection
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).
PROCEDURERadical prostatectomy with limited / no lymph node dissection
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.
Sponsors
N.N. Alexandrov National Cancer Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years. 2. Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component). 3. No evidence of metastatic spread of the tumor 4. Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis 5. Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy. 6. Signed informed consent to participate in the study.
Exclusion criteria
1. Presence of another active malignant invasive neoplasm. 2. Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis). 3. The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA). 4. Severe concomitant disease limiting participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free survival | from enrollment to the end of the study at 5 years | time from randomization to first diagnosis of distant metastasis from prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative events (length of surgery, intraoperative blood loss) | perioperatively | — |
| Duration of hospital stay | at first follow up visit (6-12 weeks post-surgery) | time from surgery to the discharge from the hospital |
| Biochemical recurrence-free survival | from enrollment to the end of the study at 5 years | time from randomization to first confirmed PSA rise \> / = 0.2 ng/ml |
| 30-day complication rate | from the start of surgery to 30 days postoperatively | rate of complications from the start of surgery to 30 days postoperatively graded by Clavien-Dindo |
| Prostate cancer specific survival | from enrollment to the end of the study at 5-7 years | time from randomization to death from prostate cancer |
| Overall survival | from enrollment to the end of the study at 5-7 years | time from randomization to to death of any cause |
| Metastasis-free survival in subgroups of patients (NCCN risk groups, operated by individual surgeon) | from enrollment to the end of the study at 5 years | time from randomization to first diagnosis of distant metastasis from prostate cancer |
| Time to treatment | from enrollment to the end of the study at 5 years | time from randomization to the first prostate cancer-related therapy |
Countries
Belarus
Outcome results
None listed