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ClinicalTrials.gov ID

NCT06776172

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

400Estimated

Last Update Posted

Jul 3, 2025Actual

Start Date

Feb 10, 2025Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2040Estimated

Official Title

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

Brief 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.

Detailed 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.

• Prostate Cancer Surgery
• Prostate Cancers

• Extended Pelvic Lymph Node Dissection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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 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 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

beat.roth@insel.ch+41 31 63 2 36 64