Clinical trial · Interventional
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
NCT04305925CI-TRIAL-00109396completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal Laser Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal Laser Ablation
- description
- The Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy.
- interventionNames
- Device: Focal Laser Ablation
Primary outcomes (1)
- measure
- Safety based on cumulative adverse events incurred
- timeFrame
- From treatment at 1 week, 1 month, and every 3 months until one year.
- description
- Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.