Clinical trial NCT06776172: Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy in High-Grade Prostate Cancer Patients 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer Surgery
Prostate Cancers
Keywords: Pelvic Lymph Node Dissection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radical prostatectomy (RP) with or without pelvic lymph node dissection
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Prostate specific antigen (PSA) persistence
timeFrame: 3 month (+/- 2 weeks) postoperatively
measure: Biochemical recurrence free survival (BCRFS)
timeFrame: within 24 months post surgery
Secondary outcomes:
measure: PSA persistence (PSAP) above detection limit
timeFrame: postoperative to the end of the study at 10-15 years
measure: Initiation time of adjuvant or salvage therapies
timeFrame: postoperative to the end of the study at 10-15 years
measure: Time to loco-regional recurrence
timeFrame: from randomization to end of study at 10-15 years
measure: Localization of progression
timeFrame: from randomization to end of study at 10-15 years
measure: Time to distant metastasis
timeFrame: postoperative to the end of the study at 10-15 years
measure: Prostate cancer-specific survival
timeFrame: postoperative to the end of the study at 10-15 years
measure: Overall survival
timeFrame: postoperative to the end of the study at 10-15 years
measure: Intraoperative complications
timeFrame: during surgery
measure: Postoperative complications
timeFrame: postoperative up to 10-15 years
measure: Adverse events (AEs) related to ePLND
timeFrame: postoperative up to 10-15 years
measure: Patient-reported outcome measures (PROMs)
timeFrame: postoperative up to 10-15 years
Other outcomes:
measure: Evaluation of risk prediction for nodal invasion
timeFrame: postoperative to the end of the study at 10-15 years
measure: Evaluation of the potential value of unilateral ePLND
timeFrame: postoperative to the end of the study at 10-15 years
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Bern
country: Switzerland
facility: Lindenhof Hospital
city: Biel
country: Switzerland
facility: Cantonal Hospital Biel
city: Chur
country: Switzerland
facility: Cantonal Hospital Chur
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
city: Liestal
country: Switzerland
facility: Cantonal Hospital Liestal
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Luzern
country: Switzerland
facility: Cantonal Hospital Luzern
city: Neuchâtel
country: Switzerland
facility: Cantonal Hospital Neuchâtel
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
city: Zürich
country: Switzerland
facility: Hospital Triemli, Zürich
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
References: