Laser zaps prostate cancer in office procedure
NCT ID NCT04305925
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 Hide 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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