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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
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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cantonal Hospital Aarau
Coordinator of this site? Confirm its status
AarauSwitzerlandRecruiting
University Hospital Basel
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BaselSwitzerlandRecruiting
Inselspital
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BernSwitzerlandRecruiting
Lindenhof Hospital
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BernSwitzerlandRecruiting
Cantonal Hospital Biel
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BielSwitzerlandRecruiting
Cantonal Hospital Chur
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ChurSwitzerlandRecruiting
University Hospital Geneva
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GenevaSwitzerlandRecruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandRecruiting
Cantonal Hospital Liestal
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LiestalSwitzerlandRecruiting
Cantonal Hospital Luzern
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LucerneSwitzerlandRecruiting
Ospedale Regionale di Lugano
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LuganoSwitzerlandRecruiting
Cantonal Hospital Neuchâtel
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NeuchâtelSwitzerlandRecruiting
Cantonal Hospital St Gallen
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Sankt GallenSwitzerlandRecruiting
University Hospital Zurich
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ZurichSwitzerlandRecruiting
Hospital Triemli, Zürich
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.