Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy in High-Grade Prostate Cancer Patients DISSECTION (2.0).

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer Surgery; Prostate Cancers

• Registration Number: NCT06776172
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Start: 2025-02
• Primary Completion: 2027-02
• Study Completion: 2040-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prostate specific antigen (PSA) persistence	3 month (+/- 2 weeks) postoperatively	defined as failure to reach a PSA value of \<0.1 ng/ml
Biochemical recurrence free survival (BCRFS)	within 24 months post surgery	time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml

Secondary Outcome Measures

Name	Time	Method
Initiation time of adjuvant or salvage therapies	postoperative to the end of the study at 10-15 years	Calculated from randomization to the start of any adjuvant or salvage therapy.; Salvage radiotherapy (SRT) to the prostatic fossa only excluding lymphatics and without androgen deprivation therapy) will not count as an event for this endpoint if: * A PSMA-PET-computed tomography prior to SRT was negative for disease beyond the prostatic fossa, and; * the SRT led to a PSA \<0.1 ng/ml (PSAP) or ≤ 0.2 ng/ml (biochemical recurrence-free survival, BCRFS), respectively.
PSA persistence (PSAP) above detection limit	postoperative to the end of the study at 10-15 years	cut-off ≥ 0.03 ng/ml
Time to loco-regional recurrence	from randomization to end of study at 10-15 years	Calculated from randomization until the first local (prostate bed) or regional (within the extent of the ePLND template) recurrence.
Localization of progression	from randomization to end of study at 10-15 years	Prostate-specific membrane antigen positron emission tomography (PSMA-PET)
Time to distant metastasis	postoperative to the end of the study at 10-15 years	Calculated from randomization until the first occurrence of distant metastasis.
Prostate cancer-specific survival	postoperative to the end of the study at 10-15 years	death due to prostate cancer
Overall survival	postoperative to the end of the study at 10-15 years	death from any cause
Intraoperative complications	during surgery	Documented using the CLASSintra classification
Postoperative complications	postoperative up to 10-15 years	Assessed using the Clavien-Dindo classification
Adverse events (AEs) related to ePLND	postoperative up to 10-15 years	Categorized according to CTCAE version 5.0
Patient-reported outcome measures (PROMs)	postoperative up to 10-15 years	tracked using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire Score 1-100 (100 indicates best quality of life score)

Trial Locations

Locations (15)

Cantonal Hospital Aarau; 🇨🇭 Aarau, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

Cantonal Hospital Biel; 🇨🇭 Biel, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Lindenhof Hospital; 🇨🇭 Bern, 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 St. Gallen; 🇨🇭 St. Gallen, Switzerland

Hospital Triemli, Zürich; 🇨🇭 Zürich, Switzerland

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Cantonal Hospital Neuchâtel; 🇨🇭 Neuchâtel, Switzerland

Cantonal Hospital Luzern; 🇨🇭 Luzern, Switzerland