RecruitingNot ApplicableNCT06776172

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

400 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches during prostate removal (radical prostatectomy) for high-risk prostate cancer: removing an extended number of lymph nodes in the pelvis versus removing no lymph nodes. The goal is to determine whether removing more lymph nodes improves cancer control and survival outcomes. **You may be eligible if...** - You are 18 years or older with a life expectancy of more than 15 years - You have high-risk prostate cancer confirmed by biopsy (grade group III–V, or grade group II with PSA above 20) - Your PSMA-PET scan shows no cancer spread to distant lymph nodes or other organs - Your surgical team has recommended a radical prostatectomy - You are fit enough for general anesthesia and surgery (ASA ≤ III, WHO performance 0–1) **You may NOT be eligible if...** - Your cancer has spread outside the prostate (distant metastasis on PSMA-PET) - Your tumor extends into nearby organs (cT4 on MRI) - You have had previous pelvic radiation or lymph node surgery - You have had prior prostate cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExtended Pelvic Lymph Node Dissection

Extended pelvic lymph node dissection during radical prostatectomy


Locations(15)

Cantonal Hospital Aarau

Aarau, Switzerland

University Hospital Basel

Basel, Switzerland

Inselspital

Bern, Switzerland

Lindenhof Hospital

Bern, Switzerland

Cantonal Hospital Biel

Biel, 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 Luzern

Lucerne, Switzerland

Ospedale Regionale di Lugano

Lugano, Switzerland

Cantonal Hospital Neuchâtel

Neuchâtel, Switzerland

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Hospital Triemli, Zürich

Zurich, Switzerland

University Hospital Zürich

Zurich, Switzerland

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NCT06776172


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