Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer
NCT ID: NCT07308990
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2025-10-29
2032-05-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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no / limited lymph node dissection
Radical 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.
limited / extended lymph node dissection
Radical 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).
Interventions
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Radical 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).
Radical 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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N.N. Alexandrov National Cancer Centre
OTHER_GOV
Responsible Party
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Locations
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N.N. Alexandrov National Cancer Centre
Lyasny, Minsk Oblast, Belarus
Countries
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Facility Contacts
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Alexander I Rolevich, Dr.
Role: primary
Maxim V Trunin
Role: backup
Other Identifiers
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011/25
Identifier Type: -
Identifier Source: org_study_id