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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancers; Prostate Cancer Surgery
• Intervention / Treatment: Procedure: Extended Pelvic Lymph Node Dissection

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cyrill Rentsch, Prof. Dr. med.; Phone Number: +41 61 26 87122; Email: cyrill.rentsch@usb.ch

Study Locations

• Switzerland
  • Aarau, Switzerland
    • Recruiting
    • Cantonal Hospital Aarau
    • Contact: Lukas Prause, Dr; Phone Number: +41 62 838 47 36; Email: uro@ksa.ch
    • Principal Investigator: Lukas Prause, Dr.
    • Sub-Investigator: Rainer Grobholz, Prof.
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Cyrill Rentsch, Prof. Dr. med.; Phone Number: +41 61 2687122; Email: cyrill.rentsch@usb.ch
    • Sub-Investigator: Helge Seifert, Prof.
    • Principal Investigator: Cyrill Rentsch, Prof. Dr. med.
    • Sub-Investigator: Christian Engesser, Dr.
    • Sub-Investigator: Alexandros Papachristofilou, Dr.
    • Sub-Investigator: Guillaume Nicolas, Dr.
  • Bern, Switzerland
    • Recruiting
    • Inselspital
    • Contact: Beat Roth, Prof. Dr.; Phone Number: +41 31 63 2 36 64; Email: beat.roth@insel.ch
    • Principal Investigator: Beat Roth, Prof. Dr.
  • Bern, Switzerland
    • Recruiting
    • Lindenhof Hospital
    • Contact: Silvan Boxler, Dr; Phone Number: +41 31 300 38 88; Email: silvan.boxler@hin.ch
    • Principal Investigator: Silvan Boxler, Dr.
  • Biel, Switzerland
    • Recruiting
    • Cantonal Hospital Biel
    • Principal Investigator: Roland Seiler-Blarer, Prof.
    • Contact: Roland Seiler-Blarer, Prof; Phone Number: +41 32 324 32 06; Email: urologie@szb-chb.ch
  • Chur, Switzerland
    • Recruiting
    • Cantonal Hospital Chur
    • Contact: Räto Strebel, PD. Dr.; Phone Number: +41 81 256 62 37; Email: urologie@ksgr.ch
    • Principal Investigator: Räto Strebel, PD. Dr.
    • Sub-Investigator: Richard Cathomas, Prof. Dr.
  • Geneva, Switzerland
    • Recruiting
    • University Hospital Geneva
    • Contact: Massimo Valerio, Prof. Dr.; Phone Number: +41 (0)22 372 79 53; Email: secretariat.urologie@hug.ch
    • Principal Investigator: Massimo Valerio, Prof. Dr.
  • Lausanne, Switzerland
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois (CHUV)
    • Contact: Ilaria Lucca, PD. Dr.; Phone Number: +41 21 314 2981; Email: Ilaria.Lucca@unil.ch
    • Principal Investigator: Ilaria Lucca, PD. Dr.
  • Liestal, Switzerland, 4410
    • Recruiting
    • Cantonal Hospital Liestal
    • Contact: Svetozar Subotic, Dr; Phone Number: +41 61 400 21 72; Email: svetozar.subotic@ksbl.ch
    • Principal Investigator: Svetozar Subotic, Dr.
  • Lugano, Switzerland
    • Recruiting
    • Ospedale Regionale di Lugano
    • Contact: Andrea Gallina, Prof. Dr.; Phone Number: +41 918116176; Email: AmbulatorioUrologia.ORL@eoc.ch
    • Principal Investigator: Andrea Gallina, Prof. Dr.
  • Luzern, Switzerland
    • Recruiting
    • Cantonal Hospital Luzern
    • Contact: Christian Fankhauser, Prof. Dr.; Phone Number: +41 41 205 45 10; Email: info.urologie@luks.ch
    • Principal Investigator: Christian Fankhauser, Prof. Dr.
  • Neuchâtel, Switzerland
    • Recruiting
    • Cantonal Hospital Neuchâtel
    • Contact: Daniel Nguyen, PD. Dr.; Phone Number: +41 327133514; Email: urologie@rhne.ch
    • Principal Investigator: Daniel Nguyen, PD. Dr.
  • St. Gallen, Switzerland
    • Recruiting
    • Cantonal Hospital St. Gallen
    • Contact: Daniel Engeler, Prof. Dr.; Phone Number: +41 71 494 30 01; Email: beckenbodenzentrum@kssg.ch
    • Principal Investigator: Daniel Engeler, Prof. Dr.
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Ashkan Mortezavi, PD. Dr.; Phone Number: +41 44 255 54 40; Email: ashkan.mortezavi@usz.ch
    • Principal Investigator: Ashkan Mortezavi, PD. Dr.
  • Zürich, Switzerland
    • Recruiting
    • Hospital Triemli, Zürich
    • Contact: Michael Müntener, Prof. Dr.; Phone Number: +41 44 416 48 61; Email: urologie.triemli@stadtspital.ch
    • Principal Investigator: Michael Müntener, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radical prostatectomy with extended pelvic lymph node dissection	Procedure: Extended Pelvic Lymph Node Dissection; Extended pelvic lymph node dissection during radical prostatectomy; Other Names: Extended Lymph Node Dissection
No Intervention: Radical prostatectomy without extended pelvic lymph node dissection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA persistence (PSAP) above detection limit	cut-off ≥ 0.03 ng/ml	postoperative to the end of the study at 10-15 years
Time to loco-regional recurrence	Calculated from randomization until the first local (prostate bed) or regional (within the extent of the ePLND template) recurrence.	from randomization to end of study at 10-15 years
Localization of progression	Prostate-specific membrane antigen positron emission tomography (PSMA-PET)	from randomization to end of study at 10-15 years
Time to distant metastasis	Calculated from randomization until the first occurrence of distant metastasis.	postoperative to the end of the study at 10-15 years
Prostate cancer-specific survival	death due to prostate cancer	postoperative to the end of the study at 10-15 years
Overall survival	death from any cause	postoperative to the end of the study at 10-15 years
Intraoperative complications	Documented using the CLASSintra classification	during surgery
Postoperative complications	Assessed using the Clavien-Dindo classification	postoperative up to 10-15 years
Adverse events (AEs) related to ePLND	Categorized according to CTCAE version 5.0	postoperative up to 10-15 years
Initiation time of adjuvant or salvage therapies	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.	postoperative to the end of the study at 10-15 years
Patient-reported outcome measures (PROMs)	tracked using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire Score 1-100 (100 indicates best quality of life score)	postoperative up to 10-15 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of risk prediction for nodal invasion	from prostate biopsy results	postoperative to the end of the study at 10-15 years
Evaluation of the potential value of unilateral ePLND		postoperative to the end of the study at 10-15 years

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2040

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pelvic Lymph Node Dissection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-02381; bb24Rentsch2; KFS-5775-02-2023 (Other Grant/Funding Number: Krebsforschung Schweiz)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No