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

NCT ID: NCT06776172

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2040-02-29

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Surgery Prostate Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Radical prostatectomy (RP) with or without pelvic lymph node dissection
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radical prostatectomy with extended pelvic lymph node dissection

Group Type EXPERIMENTAL

Extended Pelvic Lymph Node Dissection

Intervention Type PROCEDURE

Extended pelvic lymph node dissection during radical prostatectomy

Radical prostatectomy without extended pelvic lymph node dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extended Pelvic Lymph Node Dissection

Extended pelvic lymph node dissection during radical prostatectomy

Intervention Type PROCEDURE

Other Intervention Names

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Extended Lymph Node Dissection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cantonal Hospital Aarau

Aarau, , Switzerland

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Inselspital

Bern, , Switzerland

Site Status RECRUITING

Lindenhof Hospital

Bern, , Switzerland

Site Status RECRUITING

Cantonal Hospital Biel

Biel, , Switzerland

Site Status RECRUITING

Cantonal Hospital Chur

Chur, , Switzerland

Site Status RECRUITING

University Hospital Geneva

Geneva, , Switzerland

Site Status RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, , Switzerland

Site Status RECRUITING

Cantonal Hospital Liestal

Liestal, , Switzerland

Site Status RECRUITING

Cantonal Hospital Luzern

Lucerne, , Switzerland

Site Status RECRUITING

Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status RECRUITING

Cantonal Hospital Neuchâtel

Neuchâtel, , Switzerland

Site Status RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Hospital Triemli, Zürich

Zurich, , Switzerland

Site Status RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Cyrill Rentsch, Prof. Dr. med.

Role: CONTACT

+41 61 26 87122

Facility Contacts

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Lukas Prause, Dr

Role: primary

+41 62 838 47 36

Cyrill Rentsch, Prof. Dr. med.

Role: primary

+41 61 2687122

Beat Roth, Prof. Dr.

Role: primary

+41 31 63 2 36 64

Silvan Boxler, Dr

Role: primary

+41 31 300 38 88

Roland Seiler-Blarer, Prof

Role: primary

+41 32 324 32 06

Räto Strebel, PD. Dr.

Role: primary

+41 81 256 62 37

Massimo Valerio, Prof. Dr.

Role: primary

+41 (0)22 372 79 53

Ilaria Lucca, PD. Dr.

Role: primary

+41 21 314 2981

Svetozar Subotic, Dr

Role: primary

+41 61 400 21 72

Christian Fankhauser, Prof. Dr.

Role: primary

+41 41 205 45 10

Andrea Gallina, Prof. Dr.

Role: primary

+41 918116176

Daniel Nguyen, PD. Dr.

Role: primary

+41 327133514

Daniel Engeler, Prof. Dr.

Role: primary

+41 71 494 30 01

Michael Müntener, Prof. Dr.

Role: primary

+41 44 416 48 61

Ashkan Mortezavi, PD. Dr.

Role: primary

+41 44 255 54 40

Other Identifiers

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KFS-5775-02-2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-02381; bb24Rentsch2

Identifier Type: -

Identifier Source: org_study_id

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