RecruitingNot ApplicableNCT06776172

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

400 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

  • 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 Criteria11

  • 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.

Interventions

PROCEDUREExtended Pelvic Lymph Node Dissection

Extended pelvic lymph node dissection during radical prostatectomy


Locations(15)

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

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NCT06776172


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