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

Last updated: June 30, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

Extended Pelvic Lymph Node Dissection

Clinical Study ID

NCT06776172
2024-02381; bb24Rentsch2
KFS-5775-02-2023
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

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

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 are eligible ifall treatment of that malignancy was completed at least 2 years before registrationand the patient has no evidence of disease at registration. Less than 2 years isacceptable for malignancies with low risk of recurrence and/or no late recurrence.

  • Any other serious underlying medical, psychiatric, psychological, familial, orgeographical

  • condition, which in the judgment of the investigator may interfere with the planned

  • staging, treatment and follow-up, which affect patient compliance or place thepatient at

  • high risk from treatment-related complications.

  • Vulnerable men (participants incapable of judgment or participants under tutelage)will not be included in the study.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Extended Pelvic Lymph Node Dissection
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
February 29, 2040

Study Description

Prostate cancer is the second most common cancer in men globally and a major cause of cancer deaths in Europe. For men with localized prostate cancer (PCa) and a life expectancy of over 10 years, radical prostatectomy (RP) is the standard treatment. It improves survival compared to conservative management. However, there is debate about de benefit of pelvic lymph node dissection (PLND), the removal of lymph nodes in the pelvis, during RP. While PLND can be omitted in low risk PCa patients, extended PLND (ePLND) is recommended in PCa patients at high-risk for recurrence in order to improve nodal staging The DISSECTION 2.0 study aims to investigate whether extended PLND (ePLND) provides additional benefits for men with high-risk PCa. The hypothesis is that ePLND might help by removing undetectable cancer cells (micrometastases) in the lymph nodes or by better staging the disease for treatment planning. While imaging techniques like PSMA-PET are good at detecting cancer spread, they still miss approximately 60% of cancer-bearing lymph nodes, leaving room for ePLND to potentially improve outcomes.

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.

Connect with a study center

  • Cantonal Hospital Aarau

    Aarau,
    Switzerland

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Inselspital

    Bern,
    Switzerland

    Active - Recruiting

  • Lindenhof Hospital

    Bern,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Biel

    Biel,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Chur

    Chur,
    Switzerland

    Active - Recruiting

  • University Hospital Geneva

    Geneva,
    Switzerland

    Active - Recruiting

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Liestal

    Liestal, 4410
    Switzerland

    Active - Recruiting

  • Ospedale Regionale di Lugano

    Lugano,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Luzern

    Luzern,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Neuchâtel

    Neuchâtel,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital St. Gallen

    St. Gallen,
    Switzerland

    Active - Recruiting

  • Hospital Triemli, Zürich

    Zürich,
    Switzerland

    Active - Recruiting

  • University Hospital Zürich

    Zürich,
    Switzerland

    Active - Recruiting

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