Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer
Recruiting · NCT07308990 · Interventional (participants receive a specific treatment) · Lead sponsor: N.N. Alexandrov National Cancer Centre
View the official record on ClinicalTrials.gov →Interventions studied
Radical prostatectomy with extended / limited lymph node dissectionRadical prostatectomy with limited / no lymph node dissection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age over 18 years.
- Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).
- No evidence of metastatic spread of the tumor
- Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis
- Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.
- Signed informed consent to participate in the study.
Exclusion criteria
- Presence of another active malignant invasive neoplasm.
- Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).
- The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA).
- Severe concomitant disease limiting participation in the study.
Where it is running
1 location listed.
- N.N. Alexandrov National Cancer Centre - Lyasny, Minsk Oblast, Belarus