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

NCT06776172 | Recruiting DMC

• 2 other identifiers: 2024-02381; bb24Rentsch2KFS-5775-02-2023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 15

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.

Conditions

Prostate Cancer Surgery; Prostate Cancers

Keywords

Pelvic Lymph Node Dissection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• PSA persistence (PSAP) above detection limit

  postoperative to the end of the study at 10-15 years

• Initiation time of adjuvant or salvage therapies

  postoperative to the end of the study at 10-15 years

• Time to loco-regional recurrence

  from randomization to end of study at 10-15 years

• Localization of progression

  from randomization to end of study at 10-15 years

• Time to distant metastasis

  postoperative to the end of the study at 10-15 years

Other Outcomes (2)

• Evaluation of risk prediction for nodal invasion

  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

Study Arms (2)

Radical prostatectomy with extended pelvic lymph node dissection

EXPERIMENTAL

Procedure: Extended Pelvic Lymph Node Dissection

Radical prostatectomy without extended pelvic lymph node dissection

NO INTERVENTION

Interventions

Extended Pelvic Lymph Node Dissection PROCEDURE

Extended pelvic lymph node dissection during radical prostatectomy

Also known as: Extended Lymph Node Dissection

Radical prostatectomy with extended pelvic lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (15)

Cantonal Hospital Aarau

Aarau, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital

Bern, Switzerland

RECRUITING

Lindenhof Hospital

Bern, Switzerland

RECRUITING

Cantonal Hospital Biel

Biel, Switzerland

RECRUITING

Cantonal Hospital Chur

Chur, Switzerland

RECRUITING

University Hospital Geneva

Geneva, Switzerland

RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Switzerland

RECRUITING

Cantonal Hospital Liestal

Liestal, 4410, Switzerland

RECRUITING

Cantonal Hospital Luzern

Lucerne, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

Cantonal Hospital Neuchâtel

Neuchâtel, Switzerland

RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

RECRUITING

Hospital Triemli, Zürich

Zurich, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Cyrill Rentsch, Prof. Dr. med.

CONTACT

+41 61 26 87122; cyrill.rentsch@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radical prostatectomy (RP) with or without pelvic lymph node dissection

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 15, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2040
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CH (15)