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Sound waves guided by MRI aim to zap prostate tumors with fewer side effects

NCT ID NCT03814252

Disease control Sponsor: Turku University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study tests a device that uses ultrasound energy guided by MRI to precisely destroy prostate cancer tumors while sparing healthy tissue. 62 men with localized prostate cancer will receive the treatment. The goal is to see if this approach is safe and effective at controlling the cancer while reducing common side effects like incontinence and sexual problems.

What this could mean

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

Active substance
MRI-guided transurethral ultrasound ablation (device)
What this could lead to
If successful, this could offer a precise, less invasive treatment option for localized prostate cancer with fewer side effects on urinary and sexual function.
What could go wrong
This is an early-stage study with only 62 participants, so results may not apply to all patients. Risks include potential incomplete tumor destruction or side effects from the procedure.

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

62 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 95 years

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: * Language spoken: Finnish, English or Swedish * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff. * Biopsy-confirmed acinar adenocarcinoma of the prostate * Gleason score ≥ 3+4/International Society of Urological Pathology grade group ≥ 2 * High volume Gleason score 6 as determined on biopsies (\>2 positive cancer core or ≥ 50% cancer in a core) * Patient presenting low volume Gleason score 6 disease and refuses active surveillance * Non-metastatic disease; high-risk patients according to European Association of Urology risk group stratification will undergo F-Prostate specific membrane antigen-Positron Emission Tomography/Computer Tomography to exclude distant metastasis * Lesion visible on MRI (Prostate Imaging Reporting and Data System v2 4-5) * Eligible for general anesthesia (American Society of Anesthesiologists (ASA)≤ 3) Exclusion Criteria: * Contraindications for MRI (cardiac pacemaker, intracranial clips etc.) * Acute unresolved urinary tract infection * Claustrophobia * Hip replacement surgery or other metal in the pelvic area * Known allergy to gadolinium * Inability to insert urinary catheter * Suspected tumor on baseline MRI further than 30 mm or within 3 mm of the prostatic urethra * Prostate calcifications or cysts obstructing planned ultrasound beam path within the targeted tissue volume * Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Localized prostate cancer

Contacts and locations

Locations

  • Department of Urology, VSSHP, University of Turku

    Turku, Finland

More trials for these conditions

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