Limited versus extended pelvic lymph node removal during radical prostatectomy for localized or locally advanced prostate cancer
Official title: To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer
Run by N.N. Alexandrov National Cancer Centre · NCT07308990 · Data updated 2026-11-12
This study will see if removing fewer versus more pelvic lymph nodes during prostate removal helps men with localized or locally advanced prostate cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 800 (estimated) |
| Sponsor | N.N. Alexandrov National Cancer Centre Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Lyasny, Minsk Oblast) |
| Status | Recruiting |
| Started | October 29, 2025 |
| Main results expected | May 30, 2030 |
| Study ends | May 30, 2032 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07308990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with localized or locally advanced prostate adenocarcinoma who are fit for radical prostatectomy, have no distant metastases, and can give informed consent are the intended participants.
✕Probably not a fit
Patients with metastatic disease, another active invasive cancer, prior pelvic radiation or other contraindications to lymph node dissection, or severe comorbidities are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial enrolling adults with histologically confirmed localized or locally advanced prostate adenocarcinoma who are suitable for radical prostatectomy. Participants are randomly assigned to radical prostatectomy with either limited (or no) pelvic lymph node dissection or an extended pelvic lymph node dissection. The study will compare cancer-related outcomes and postoperative complications, with planned follow-up for recurrence and adverse events. Patients with evidence of distant metastases or contraindications to lymph node dissection are excluded based on preoperative imaging and clinical assessment.
Why it matters
Potential benefit: If successful, the results could clarify whether extended lymph node removal improves cancer control or whether limited removal lowers surgical risks without worsening outcomes.
How similar studies have gone: Previous randomized and observational studies of the extent of lymph node dissection in prostate cancer have shown mixed results, so a clear benefit has not been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
N.N. Alexandrov National Cancer Centre
Lyasny, Minsk Oblast, Belarus Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.