Extended versus no pelvic lymph node removal during radical prostatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares outcomes for men with high‑risk localized prostate cancer who undergo radical prostatectomy with extended pelvic lymph node dissection (ePLND) versus without extended node removal. Eligible participants must be PSMA‑PET negative and fit for surgery, and will be recruited at Swiss surgical centers. The study will track surgical staging accuracy, postoperative complications, and longer‑term cancer outcomes such as recurrence. Results will show whether the extra node removal improves detection of micrometastases or changes subsequent treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years and life expectancy \>15 years
* Any biopsy-proven WHO/ISUP grade groups III-V PCa
* High-risk prostate cancer defined as:

  * Any biopsy-proven WHO/ISUP grade group III-V PCa or
  * ISUP grade group II and PSA \> 20 ng/ml
* PSMA-PET: negative staging for regional and distant metastasis
* multidisciplinary tumorboard recommendation for radical prostatectomy
* WHO performance status 0-1
* Adequate condition (ASA ≤ III) for general anesthesia and RP

Exclusion Criteria:

* ISUP grade group I PCa and cT1 or cT2 (MRI)
* cT4 (MRI) PCa
* PSMA-PET: positive staging for local and distant metastasis
* Any prior neoadjuvant, local or systemic treatment for PCa
* Previous PLND or pelvic radiotherapy
* Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
* Any other serious underlying medical, psychiatric, psychological, familial, or geographical
* condition, which in the judgment of the investigator may interfere with the planned
* staging, treatment and follow-up, which affect patient compliance or place the patient at
* high risk from treatment-related complications.
* Vulnerable men (participants incapable of judgment or participants under tutelage) will not be included in the study.

Where it's running

• Cantonal Hospital Aarau
  Aarau, Switzerland Recruiting
• University Hospital Basel
  Basel, Switzerland Recruiting
• Inselspital
  Bern, Switzerland Recruiting
• Lindenhof Hospital
  Bern, Switzerland Recruiting
• Cantonal Hospital Biel
  Biel, Switzerland Recruiting
• Cantonal Hospital Chur
  Chur, Switzerland Recruiting

Study contacts

• Study coordinator: Cyrill Rentsch, Prof. Dr. med.
• Email: cyrill.rentsch@usb.ch
• Phone: +41 61 26 87122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.