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Prostate Cancer SurgeryNCT06776172

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

A study testing Extended Pelvic Lymph Node Dissection in people with Prostate Cancer Surgery and Prostate Cancers, run by University Hospital, Basel, Switzerland at 15 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Surgery, Prostate Cancers
What is being tested?
Extended Pelvic Lymph Node Dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
15 sitesSwitzerland
Study dates
10 Feb 2025to Feb 2040
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • multidisciplinary tumorboard recommendation for radical prostatectomy
  • WHO performance status 0-1
  • Adequate condition (ASA ≤ III) for general anesthesia and RP

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cyrill Rentsch, Prof. Dr. med. contact

+41 61 26 87122

cyrill.rentsch@usb.ch

15 sites in 1 country

Switzerland15 sites, 15 recruiting

  • Cantonal Hospital Aarau

    Aarau

    Lukas Prause, Dr, +41 62 838 47 36, uro@ksa.ch

    Lukas Prause, Dr.

    Recruiting

  • University Hospital Basel

    Basel, 4031

    Cyrill Rentsch, Prof. Dr. med., +41 61 2687122, cyrill.rentsch@usb.ch

    Helge Seifert, Prof.

    Recruiting

  • Inselspital

    Bern

    Beat Roth, Prof. Dr., +41 31 63 2 36 64, beat.roth@insel.ch

    Beat Roth, Prof. Dr.

    Recruiting

  • Lindenhof Hospital

    Bern

    Silvan Boxler, Dr, +41 31 300 38 88, silvan.boxler@hin.ch

    Silvan Boxler, Dr.

    Recruiting

  • Cantonal Hospital Biel

    Biel

    Roland Seiler-Blarer, Prof, +41 32 324 32 06, urologie@szb-chb.ch

    Roland Seiler-Blarer, Prof.

    Recruiting

  • Cantonal Hospital Chur

    Chur

    Räto Strebel, PD. Dr., +41 81 256 62 37, urologie@ksgr.ch

    Räto Strebel, PD. Dr.

    Recruiting

  • University Hospital Geneva

    Geneva

    Massimo Valerio, Prof. Dr., +41 (0)22 372 79 53, secretariat.urologie@hug.ch

    Massimo Valerio, Prof. Dr.

    Recruiting

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne

    Ilaria Lucca, PD. Dr., +41 21 314 2981, Ilaria.Lucca@unil.ch

    Ilaria Lucca, PD. Dr.

    Recruiting

  • Cantonal Hospital Liestal

    Liestal, 4410

    Svetozar Subotic, Dr, +41 61 400 21 72, svetozar.subotic@ksbl.ch

    Svetozar Subotic, Dr.

    Recruiting

  • Cantonal Hospital Luzern

    Lucerne

    Christian Fankhauser, Prof. Dr., +41 41 205 45 10, info.urologie@luks.ch

    Christian Fankhauser, Prof. Dr.

    Recruiting

  • Ospedale Regionale di Lugano

    Lugano

    Andrea Gallina, Prof. Dr., +41 918116176, AmbulatorioUrologia.ORL@eoc.ch

    Andrea Gallina, Prof. Dr.

    Recruiting

  • Cantonal Hospital Neuchâtel

    Neuchâtel

    Daniel Nguyen, PD. Dr., +41 327133514, urologie@rhne.ch

    Daniel Nguyen, PD. Dr.

    Recruiting

  • Cantonal Hospital St. Gallen

    Sankt Gallen

    Daniel Engeler, Prof. Dr., +41 71 494 30 01, beckenbodenzentrum@kssg.ch

    Daniel Engeler, Prof. Dr.

    Recruiting

  • Hospital Triemli, Zürich

    Zurich

    Michael Müntener, Prof. Dr., +41 44 416 48 61, urologie.triemli@stadtspital.ch

    Michael Müntener, Prof. Dr.

    Recruiting

  • University Hospital Zürich

    Zurich

    Ashkan Mortezavi, PD. Dr., +41 44 255 54 40, ashkan.mortezavi@usz.ch

    Ashkan Mortezavi, PD. Dr.

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Extended Pelvic Lymph Node Dissection
Keywords
Pelvic Lymph Node Dissection
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Pelvic Lymph Node DissectionProcedure or surgery

    Also called Extended Lymph Node Dissection

    Extended pelvic lymph node dissection during radical prostatectomy

Study groups in NCT06776172
Study groupRoleWhat they receive
Radical prostatectomy with extended pelvic lymph node dissectionExperimentalNot described
Receives: Procedure: Extended Pelvic Lymph Node Dissection
Radical prostatectomy without extended pelvic lymph node dissectionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate specific antigen (PSA) persistence

    defined as failure to reach a PSA value of <0.1 ng/ml

    Measured: 3 month (+/- 2 weeks) postoperatively

  2. Biochemical recurrence free survival (BCRFS)

    time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml

    Measured: within 24 months post surgery

Secondary outcomes (11)

  1. PSA persistence (PSAP) above detection limit

    cut-off ≥ 0.03 ng/ml

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

  2. 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.

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

  3. Time to loco-regional recurrence

    Calculated from randomization until the first local (prostate bed) or regional (within the extent of the ePLND template) recurrence.

    Measured: from randomization to end of study at 10-15 years

  4. Localization of progression

    Prostate-specific membrane antigen positron emission tomography (PSMA-PET)

    Measured: from randomization to end of study at 10-15 years

  5. Time to distant metastasis

    Calculated from randomization until the first occurrence of distant metastasis.

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

  6. Prostate cancer-specific survival

    death due to prostate cancer

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

  7. Overall survival

    death from any cause

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

  8. Intraoperative complications

    Documented using the CLASSintra classification

    Measured: during surgery

  9. Postoperative complications

    Assessed using the Clavien-Dindo classification

    Measured: postoperative up to 10-15 years

  10. Adverse events (AEs) related to ePLND

    Categorized according to CTCAE version 5.0

    Measured: postoperative up to 10-15 years

  11. 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)

    Measured: postoperative up to 10-15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start10 Feb 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Radical prostatectomy (RP) with or without pelvic lymph node dissection
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06776172
Sponsor's protocol ID
2024-02381; bb24Rentsch2
Other IDs
KFS-5775-02-2023
Status last verified
Jun 2025
First submitted
6 Jan 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Extended Pelvic Lymph Node Dissection in people with Prostate Cancer Surgery and Prostate Cancers, run by University Hospital, Basel, Switzerland at 15 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cyrill Rentsch, Prof. Dr. med. (+41 61 26 87122, cyrill.rentsch@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate specific antigen (PSA) persistence (time frame: 3 month (+/- 2 weeks) postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06776172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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