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Could less lymph node surgery be better for High-Risk prostate cancer?

NCT ID NCT07580196

Disease control Sponsor: University of Turin, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at men with high-risk prostate cancer that appears on only one side of the prostate. During robotic surgery to remove the prostate, doctors will either remove lymph nodes from both sides of the pelvis or just the side with cancer. The goal is to see if removing fewer lymph nodes reduces side effects and recovery time without raising the risk of cancer coming back. About 820 men will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male patients aged 18 years or older * Histologically confirmed unilateral high-risk localized prostate cancer, defined by at least one of the following: ISUP Grade Group 4 or 5; suspicion of at least cT3a disease on multiparametric MRI and/or PSMA PET; or PSA greater than or equal to 20 ng/mL with a unilateral index lesion * Unilateral features of the index lesion defined by biopsy, multiparametric MRI, and PSMA PET * No PSMA PET-positive pelvic lymph nodes contralateral to the dominant side of the prostate cancer * No significant contralateral PSMA uptake on the non-dominant side, defined as lesions with PRIMARY score 3 to 5 * No contralateral index lesion on multiparametric MRI subsequently confirmed by prostate biopsy * No high-risk histology on the side contralateral to the dominant lesion, including ISUP Grade Group greater than 3 or unconventional prostate cancer histology * No frank extracapsular invasion or seminal vesicle invasion on the contralateral side * Up to two positive systematic cores with unfavorable intermediate-risk disease or up to four with favorable intermediate-risk disease are allowed on the contralateral side * A maximum of two pelvic PSMA-positive lymph nodes allowed on the dominant side * Clinically localized disease, defined as less than cT4 on multiparametric MRI and no distant metastases, including no retroperitoneal lymph nodes on PSMA PET * Life expectancy greater than 10 years according to physician judgment * Scheduled for robot-assisted radical prostatectomy and fit for surgery * Written informed consent provided Exclusion Criteria: * Any prostate cancer treatment prior to prostatectomy, including androgen deprivation therapy, neoadjuvant chemotherapy, radiotherapy, or focal ablative therapy * Prior active treatment for prostate cancer * Contralateral ISUP Grade Group 4 to 5 prostate cancer * Contralateral ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores * Contralateral cT3 disease on multiparametric MRI * N1 or M1 disease on PSMA PET or multiparametric MRI, except for up to two positive pelvic lymph nodes on the dominant side * No systematic prostate biopsies performed, with a minimum of 10 cores, and targeted biopsies when a target lesion is present * Other active malignancy * Contraindication to multiparametric MRI and/or PSMA PET * Inability to provide written informed consent * Age younger than 18 years * ASA score greater than 3 * Any contraindication to pelvic lymph node dissection * Severe psychiatric disease * Inadequate hematologic and/or coagulation function * Active infection * Any other serious medical, psychiatric, psychological, familial, or geographic condition that, in the judgment of the investigator, may interfere with staging, treatment, follow-up, compliance, or increase treatment-related risk * Patients with prior malignancy treated with curative intent are eligible only with mandatory approval by the local multidisciplinary tumor board

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette

    RECRUITING

    Torino, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Humanitas Clinical and Research Centre & Humanitas University

    NOT_YET_RECRUITING

    Rozzano, Milano, 20089, Italy

  • IEO, Istituto Europeo di Oncologia

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • IFO - Istituti Fisioterapici Ospitalieri

    NOT_YET_RECRUITING

    Roma, 00144, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • IRCCS Ospedale Policlinico San Martino & University of Genoa

    NOT_YET_RECRUITING

    Genova, 16132, Italy

  • Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Università Tor Vergata / Policlinico Tor Vergata

    NOT_YET_RECRUITING

    Roma, 00133, Italy

  • Università degli Studi di Firenze / AOU Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia

    NOT_YET_RECRUITING

    Foggia, 71122, Italy

  • Università degli Studi di Modena / AOU Modena

    NOT_YET_RECRUITING

    Modena, 41124, Italy

  • Università degli Studi di Verona / AOU Verona

    NOT_YET_RECRUITING

    Verona, 37134, Italy

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