Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.
NCT ID: NCT06776172
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-02-10
2040-02-29
Brief Summary
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Detailed Description
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ePLND involves removing more lymph nodes than standard PLND, leading to better detection of cancer spread. However, it also increases surgery time and complications slightly, though serious complications are rare.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical prostatectomy with extended pelvic lymph node dissection
Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection during radical prostatectomy
Radical prostatectomy without extended pelvic lymph node dissection
No interventions assigned to this group
Interventions
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Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection during radical prostatectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Locations
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Cantonal Hospital Aarau
Aarau, , Switzerland
University Hospital Basel
Basel, , Switzerland
Inselspital
Bern, , Switzerland
Lindenhof Hospital
Bern, , Switzerland
Cantonal Hospital Biel
Biel, , Switzerland
Cantonal Hospital Chur
Chur, , Switzerland
University Hospital Geneva
Geneva, , Switzerland
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, , Switzerland
Cantonal Hospital Liestal
Liestal, , Switzerland
Cantonal Hospital Luzern
Lucerne, , Switzerland
Ospedale Regionale di Lugano
Lugano, , Switzerland
Cantonal Hospital Neuchâtel
Neuchâtel, , Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
Hospital Triemli, Zürich
Zurich, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KFS-5775-02-2023
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-02381; bb24Rentsch2
Identifier Type: -
Identifier Source: org_study_id
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