Laser zaps prostate cancer in office procedure

NCT ID NCT04305925

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested a new laser treatment for prostate cancer that can be done in a doctor's office. Ten men with early-stage prostate cancer received focal laser ablation guided by MRI and ultrasound images. The main goal was to see if the procedure is safe and feasible, not yet to prove it works.

What this could mean

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

Active substance
focal laser ablation (Orion system)
What this could lead to
If successful, this could offer a less invasive, office-based treatment option for localized prostate cancer, potentially reducing side effects compared to surgery or radiation.
What could go wrong
This is a very early feasibility study with only 10 participants, so results may not apply broadly. The procedure is still investigational, and safety and effectiveness are not yet proven.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

10 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2026

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

40 to 85 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: * Subjects with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7) x Age 40 to 85 years of age * Multi-parametric MRI at University of California at Los Angeles (UCLA) within 6 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3). x Prostate volume 20cc to 80cc * Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 month of biopsy results * Histologically-confirmed adenocarcinoma from targeted biopsy cores x Overall Gleason = 3+4 or 4+3 * Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy) * Signed informed consent for the FLA treatment through the 12 month follow-up Exclusion Criteria: * Any significant cancer outside of the intended treatment zone, defined as Gleason score 7 x \< 10 years life expectancy * Any medical condition that would compromise the subject's ability to safely ● Active bleeding disorder * Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure * Active urinary tract infection x Active prostate abscess, prostatitis, or neurogenic bladder x Any prior treatment for prostate cancer, including: * Radical prostatectomy * Radiation therapy (external beam or brachytherapy) * Cryotherapy * High intensity focused ultrasound (HIFU) treatment o Photodynamic therapy o Androgen deprivation therapy * Prior prostate, bladder neck, or urethral stricture surgery * Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization * Transurethral incision of bladder neck x Urethral stricture dilation or reconstruction * Use of 5-alpha reductase inhibitors within 6 months of treatment x Prior significant rectal surgery (hemorrhoidectomy is acceptable) * Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device * Inflammatory bowel disease x Urinary tract or rectal fistula x Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery. * Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)

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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.

Contacts and locations

Locations

  • University of California at Los Angeles

    Los Angeles, California, 90024, United States

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