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About
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.
Full description
The primary objective is to evaluate the safety and feasibility of 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. In addition, changes in health-related quality of life (HRQOL) will be evaluated using Expanded Prostate Index Composite for Clinical Practice (EPIC-CP), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Decision Regret Scale.
This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the Orion System. In this study, the investigators intend to use the investigational Orion system to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. Subjects will return to clinic 1 week, 1 month, and every 3 months until one year post-FLA to be monitored for adverse events and complete Health Related Quality of Life (HRQOL) questionnaires. Biomarker (PSA) kinetics will also be monitored.
Enrollment
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Inclusion criteria
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:
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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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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