Clinical trial · Interventional
Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer
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
NCT07308990CI-TRIAL-00099820recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Patients Undergoing Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical prostatectomy with extended / limited lymph node dissection | Procedure | — | UNRESOLVED |
| Radical prostatectomy with limited / no lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- no / limited lymph node dissection
- interventionNames
- Procedure: Radical prostatectomy with limited / no lymph node dissection
- type
- EXPERIMENTAL
- label
- limited / extended lymph node dissection
- interventionNames
- Procedure: Radical prostatectomy with extended / limited lymph node dissection
Primary outcomes (1)
- measure
- Metastasis-free survival
- timeFrame
- from enrollment to the end of the study at 5 years
- description
- time from randomization to first diagnosis of distant metastasis from prostate cancer
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.