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3D-Guided heat therapy targets enlarged prostate without cutting

NCT ID NCT05443451

Symptom relief Sponsor: Chinese University of Hong Kong 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests a new way to treat urinary symptoms caused by an enlarged prostate. Using 3D ultrasound guidance, doctors insert a thin needle through the skin between the scrotum and anus to deliver microwave heat directly to the overgrown prostate tissue. The approach aims to shrink the prostate while protecting the bladder neck and urethra. The study enrolls 12 men over age 50 with moderate-to-severe symptoms and a prostate size between 30 and 80 cc.

What this could mean

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

Active substance
microwave ablation device
What this could lead to
If successful, this could offer a less invasive treatment option for men with enlarged prostate, reducing urinary symptoms while preserving sexual function.
What could go wrong
This is a very small pilot study with only 12 participants, so results may not apply to all men. The procedure carries risks such as bleeding, infection, or damage to nearby structures.

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

12 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2023

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

50 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: * Age over 50 years. * Benign prostatic hyperplasia with prostate size 30-80 cc * IPSS ≥ 14 * PSA ≤ 4 ng/mL or PSA \>4 ng/mL with no evidence of suspicious lesion on mpMRI * Maximum urine flow rate (Qmax) ≤ 15 mL/s. * Post-Void Residual ≤ 150 mL. * Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation. * Informed written consent Exclusion Criteria: * Significant intravesical median lobe hyperplasia. * Suspicious lesion on mpMRI prostate * History of prostate, bladder or urethral surgery. * History of prostate cancer * Presence of stones, bladder diverticulum and/or bladder tumor * History of long-term indwelling catheter. * Urethral stricture * Known coagulopathy or on anticoagulant * Presence of a pacemaker. * Active infection * Dysuria due to bladder dysfunction. * Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit. * Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury). * Contraindications for mpMRI exam or MR contrast * Acute and/or chronic renal failure (GFR \<50 ml/min and serum creatinine \> 1.5 mg/d). * Patient currently participating in another interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

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

Prostate hyperplasia

Contacts and locations

Locations

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

More trials for these conditions

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