Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New robotic surgery vs. ultrasound: which focal therapy wins for prostate cancer?

NCT ID NCT05610852

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study compares two treatments for low-to-intermediate risk prostate cancer: a new robotic surgery that removes part of the prostate through a single small incision, and high-intensity focused ultrasound (HIFU) that uses sound waves to destroy cancer cells. About 276 men will be randomly assigned to one of the two procedures. The main goal is to see which treatment better prevents cancer from coming back, based on MRI scans and biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Single-port robotic partial prostatectomy and high-intensity focused ultrasound (HIFU)
What this could lead to
If successful, this could show which focal therapy is more effective at controlling prostate cancer with fewer side effects, potentially becoming a standard treatment option.
What could go wrong
This is a single-center study, and results may not apply to all patients. Both procedures carry risks like infection, bleeding, or urinary problems, and the trial is still recruiting.

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 276 people

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

Started

Jan 2024

Expected to finish

Dec 2028

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

19 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: * Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater * The MRI performed must include at least: * A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized, * A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2, * A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes * A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow. * If necessary, subtracted images are calculated * Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core * Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5 * Life expectancy greater than 10 years. * Age \>18 years. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis * Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy * Uncorrected coagulopathy or history of Latex allergy * Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms * Poor surgical risk (defined as American Society of Anesthesiology score \> 3). * Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.) * Prostate size larger than 80 grams. * Subjects with prostatic Calcification (\>0.5 cc) close to the area to be treated. * Subjects with extraprostatic extension or cribriform pattern on biopsy. * Subjectes with sexual dysfunction defined as SHIM score \< 17 * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostate adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.