title: Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial.
abstract: Focal laser ablation is an investigational technique to treat prostate cancer in a region confined manner via coagulative necrosis. This phase I trial primarily examines the safety of transrectal magnetic resonance imaging guided (in-bore) focal laser ablation in men with intermediate risk prostate cancer. An exploratory end point is cancer control after 6 months.
  
  
  
  In an institutional review board approved trial we studied focal laser ablation in 8 men with intermediate risk prostate cancer diagnosed using magnetic resonance-ultrasound fusion. Focal laser ablation was performed by inserting a cylindrically diffusing, water cooled laser fiber into magnetic resonance visible regions of interest, followed by interstitial heating at 10 to 15 W for up to 3 minutes. Secondary safety monitors (thermal probes) were inserted to assess the accuracy of magnetic resonance thermometry. Comprehensive magnetic resonance-ultrasound fusion biopsy was performed after 6 months. Adverse events and health related quality of life questionnaires were recorded.
  
  
  
  Focal laser ablation was successfully performed in all 8 subjects. No grade 3 or greater adverse events occurred and no changes in International Prostate Symptom Score or International Index of Erectile Function 5 were observed. Ablation zones, as measured by posttreatment magnetic resonance imaging, had a median volume of 3 cc or 7.7% of prostate volume. Prostate specific antigen decreased in 7 men (p <0.01). At followup magnetic resonance-ultrasound fusion biopsy cancer was not detected in the ablation zone in 5 men but was present outside the treatment margin in 6 men.
  
  
  
  Focal laser ablation of the prostate is feasible and safe in men with intermediate risk prostate cancer without serious adverse events or changes in urinary or sexual function at 6 months. Comprehensive biopsy followup indicates that larger treatment margins than previously thought necessary may be required for complete tumor ablation.
authors.affiliation: Department of Urology, University of California, Los Angeles, Los Angeles, California; Department of Bioengineering, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Shyam
authors.initials: S
authors.lastname: Natarajan
authors.affiliation: Department of Radiology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Steven
authors.initials: S
authors.lastname: Raman
authors.affiliation: Department of Bioengineering, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Alan M
authors.initials: AM
authors.lastname: Priester
authors.affiliation: Department of Bioengineering, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California.
authors.forename: James
authors.initials: J
authors.lastname: Garritano
authors.affiliation: Department of Radiology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Daniel J A
authors.initials: DJ
authors.lastname: Margolis
authors.affiliation: Department of Urology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Patricia
authors.initials: P
authors.lastname: Lieu
authors.affiliation: Department of Urology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Macairan
authors.affiliation: Department of Pathology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Jiaoti
authors.initials: J
authors.lastname: Huang
authors.affiliation: Department of Bioengineering, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California.
authors.forename: Warren
authors.initials: W
authors.lastname: Grundfest
authors.affiliation: Department of Urology, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California. Electronic address: lmarks@mednet.ucla.edu.
authors.forename: Leonard S
authors.initials: LS
authors.lastname: Marks
mesh_terms: D000368:Aged; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D053685:Laser Therapy / Q000379:methods*; D053783:Magnetic Resonance Imaging, Interventional; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery*; D016896:Treatment Outcome
keywords: ablation techniques; laser therapy; multimodal imaging; prostatic neoplasms