Extended versus no pelvic lymph node removal during radical prostatectomy
Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection at Radical Prostatectomy in PSMA PET Negative Staged Men: A Multicenter, Randomized Phase III Trial
This trial tests whether removing more pelvic lymph nodes during prostate removal surgery helps men with high‑risk prostate cancer who have no metastases on PSMA‑PET.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 15 sites (Aarau and 14 other locations) |
| Trial ID | NCT06776172 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 or older with high‑risk prostate cancer (ISUP grade III–V, or ISUP II with PSA > 20 ng/ml), a life expectancy over 15 years, negative PSMA‑PET, and who are fit for radical prostatectomy are the intended participants.
Not a fit: Patients with low‑risk disease, documented regional or distant metastases on PSMA‑PET, prior pelvic lymph node dissection or pelvic radiotherapy, prior prostate cancer treatment, or who are unfit for surgery are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, ePLND could improve detection and removal of microscopic cancer in lymph nodes, potentially lowering recurrence and better directing additional treatments.
How similar studies have performed: Prior studies show ePLND improves nodal staging but randomized evidence that it provides a clear therapeutic benefit is limited and results to date are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarau and 14 other locations
- 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)
- University Hospital Geneva — Geneva, Switzerland (Recruiting)
- Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Switzerland (Recruiting)
- Cantonal Hospital Liestal — Liestal, Switzerland (Recruiting)
- Cantonal Hospital Luzern — Lucerne, Switzerland (Recruiting)
- Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)
- Cantonal Hospital Neuchâtel — Neuchâtel, Switzerland (Recruiting)
- Cantonal Hospital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Hospital Triemli, Zürich — Zurich, Switzerland (Recruiting)
- University Hospital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Cyrill Rentsch, Prof. Dr. med.
- Email: cyrill.rentsch@usb.ch
- Phone: +41 61 26 87122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.