NCT04305925CompletedEarly phase 1
Focal Laser Ablation of Prostate Cancer
Office-based Focal Laser Ablation of Prostate Cancer: An Early Feasibility Study Using MRI/US Image Fusion for Guidance
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 6 Mar 2020
- Start date
- 30 Jan 2020
- Primary completion date
- 30 Jan 2023
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04305925
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 10
- From 30 Jan 2020 to the primary completion date, 30 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of 5-alpha reductase inhibitors within 6 months of treatment x Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- Inflammatory bowel disease x Urinary tract or rectal fistula x Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery.
Other illness
- Any medical condition that would compromise the subject's ability to safely ● Active bleeding disorder
- Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)
Age
- Any significant cancer outside of the intended treatment zone, defined as Gleason score 7 x \< 10 years life expectancy
Other
- 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
- Transurethral incision of bladder neck x Urethral stricture dilation or reconstruction
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California at Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.