NCT06776172Recruiting
Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the DISSECTION 2.0 study is to determine whether extended pelvic lymph node dissection (ePLND) provides a therapeutic benefit for high-risk prostate cancer patients by improving cancer staging and potentially removing micrometastatic disease, ultimately improving their outcomes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 10 Feb 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Prostate cancer
- NCT number
- NCT06776172
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 10 Feb 2025 to the primary completion date, Feb 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior neoadjuvant, local or systemic treatment for PCa
- Previous PLND or pelvic radiotherapy
Other illness
- 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
Other
- ISUP grade group I PCa and cT1 or cT2 (MRI)
- cT4 (MRI) PCa
- PSMA-PET: positive staging for local and distant metastasis
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cantonal Hospital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Lindenhof Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Cantonal Hospital Biel Coordinator of this site? Confirm its status | Biel | Switzerland | Recruiting |
| Cantonal Hospital Chur Coordinator of this site? Confirm its status | Chur | Switzerland | Recruiting |
| University Hospital Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Cantonal Hospital Liestal Coordinator of this site? Confirm its status | Liestal | Switzerland | Recruiting |
| Cantonal Hospital Luzern Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| Ospedale Regionale di Lugano Coordinator of this site? Confirm its status | Lugano | Switzerland | Recruiting |
| Cantonal Hospital Neuchâtel Coordinator of this site? Confirm its status | Neuchâtel | Switzerland | Recruiting |
| Cantonal Hospital St Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Hospital Triemli, Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.