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

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

Overview

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.

Interventions

• Procedure Extended Pelvic Lymph Node Dissection
  Extended pelvic lymph node dissection during radical prostatectomy

Primary outcome measures

• Prostate specific antigen (PSA) persistence [Time frame: 3 month (+/- 2 weeks) postoperatively]
• Biochemical recurrence free survival (BCRFS) [Time frame: within 24 months post surgery]

Secondary outcome measures (11)

• PSA persistence (PSAP) above detection limit [Time frame: postoperative to the end of the study at 10-15 years]
• Initiation time of adjuvant or salvage therapies [Time frame: postoperative to the end of the study at 10-15 years]
• Time to loco-regional recurrence [Time frame: from randomization to end of study at 10-15 years]
• Localization of progression [Time frame: from randomization to end of study at 10-15 years]
• Time to distant metastasis [Time frame: postoperative to the end of the study at 10-15 years]
• Prostate cancer-specific survival [Time frame: postoperative to the end of the study at 10-15 years]
• Overall survival [Time frame: postoperative to the end of the study at 10-15 years]
• Intraoperative complications [Time frame: during surgery]
• Postoperative complications [Time frame: postoperative up to 10-15 years]
• Adverse events (AEs) related to ePLND [Time frame: postoperative up to 10-15 years]
• Patient-reported outcome measures (PROMs) [Time frame: postoperative up to 10-15 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 15 centers

• Cantonal Hospital Aarau — Aarau
• University Hospital Basel — Basel
• Inselspital — Bern
• Lindenhof Hospital — Bern
• Cantonal Hospital Biel — Biel
• Cantonal Hospital Chur — Chur
• University Hospital Geneva — Geneva
• Centre hospitalier universitaire vaudois (CHUV) — Lausanne
• … and 7 more centers

Identifiers

NCT: NCT06776172 · 2024-02381; bb24Rentsch2 · KFS-5775-02-2023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗