Shyam Natarajan1, Steven Raman2, Alan M Priester3, James Garritano3, Daniel J A Margolis2, Patricia Lieu4, Maria L Macairan4, Jiaoti Huang5, Warren Grundfest3, Leonard S Marks6. 1. 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. 2. Department of Radiology, University of California, Los Angeles, Los Angeles, California. 3. 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. 4. Department of Urology, University of California, Los Angeles, Los Angeles, California. 5. Department of Pathology, University of California, Los Angeles, Los Angeles, California. 6. 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.
Abstract
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Authors: Simpa S Salami; Jeremy B Kaplan; Srinivas Nallandhighal; Mandeep Takhar; Jeffrey J Tosoian; Matthew Lee; Junhee Yoon; Daniel H Hovelson; Komal R Plouffe; Samuel D Kaffenberger; Edward M Schaeffer; R Jeffrey Karnes; Tamara L Lotan; Todd M Morgan; Arvin K George; Jeffrey S Montgomery; Matthew S Davenport; Sungyong You; Scott A Tomlins; Nicole E Curci; Hyung L Kim; Daniel E Spratt; Aaron M Udager; Ganesh S Palapattu Journal: JCO Precis Oncol Date: 2019-06-12