Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.
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.
| Condition(s) | Prostate Cancer Surgery, Prostate Cancers |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University Hospital, Basel, Switzerland |
| Locations | Aarau, Switzerland; Basel, Switzerland; Bern, Switzerland; Bern, Switzerland; Biel, Switzerland; Chur, Switzerland (+9 more sites) |
| Start date | 2025-02-10 |
| NCT ID | NCT06776172 |
| Official listing | https://clinicaltrials.gov/study/NCT06776172 |