Focal Laser Ablation of Prostate Cancer (NCT04305925) | Clinical Trial Compass
CompletedEarly Phase 1
Focal Laser Ablation of Prostate Cancer
United States10 participantsStarted 2020-01-30
Plain-language summary
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.
Who can participate
Age range40 Years – 85 Years
SexMALE
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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)
* Cr…
What they're measuring
1
Safety based on cumulative adverse events incurred
Timeframe: From treatment at 1 week, 1 month, and every 3 months until one year.