Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.

Recruiting now · Not applicable

Conditions studied: Prostate Cancer Surgery, Prostate Cancers

In brief

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.

Key facts

Study ID

NCT06776172

Run by

University Hospital, Basel, Switzerland

People needed

400

Starts

2025-02-10

Expected to finish

2040-02-01

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Cantonal Hospital Aarau — Aarau, Switzerland (enrolling)
• University Hospital Basel — Basel, Switzerland (enrolling)
• Inselspital — Bern, Switzerland (enrolling)
• Lindenhof Hospital — Bern, Switzerland (enrolling)
• Cantonal Hospital Biel — Biel, Switzerland (enrolling)
• Cantonal Hospital Chur — Chur, Switzerland (enrolling)
• University Hospital Geneva — Geneva, Switzerland (enrolling)
• Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Switzerland (enrolling)
• Cantonal Hospital Liestal — Liestal, Switzerland (enrolling)
• Cantonal Hospital Luzern — Lucerne, Switzerland (enrolling)
• Ospedale Regionale di Lugano — Lugano, Switzerland (enrolling)
• Cantonal Hospital Neuchâtel — Neuchâtel, Switzerland (enrolling)
• Cantonal Hospital St. Gallen — Sankt Gallen, Switzerland (enrolling)
• Hospital Triemli, Zürich — Zurich, Switzerland (enrolling)
• University Hospital Zürich — Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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