Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial.

Focal laser ablation (FLA) of prostate cancer is an investigational technique to treat CaP in a region-confined manner via coagulative necrosis. This phase 1 trial primarily examines the safety of transrectal MRI-guided (in-bore) FLA in men with intermediate-risk CaP.

An exploratory endpoint is cancer control after 6 months.

In an IRB-approved trial, we studied FLA in eight men with intermediate-risk CaP, diagnosed using MR-US fusion. FLA was performed by inserting a cylindrically-diffusing, water-cooled laser fiber into MR-visible regions of interest, followed by interstitial heating at 10-15 W for up to 3 minutes. Secondary safety monitors (thermal probes) were inserted to assess the accuracy of MR thermometry. Comprehensive MR-US fusion biopsy was performed after six months. Adverse events and health-related quality of life questionnaires were recorded.

FLA was successfully performed in all 8 subjects. No grade ≥3 adverse events occurred, and no changes in IPSS or IIEF-5 were observed. Ablation zones, as measured by post-treatment MRI, had a median volume of 3 cc or 7. 7% of prostate volume. PSA declined in seven men (p<0. 01). At follow-up MR-US fusion biopsy, cancer was not detected in the ablation zone in 5 men, but was present outside the treatment margin in 6 men.

FLA of the prostate is feasible and safe in men with intermediate-risk CaP, without serious adverse events or changes in urinary or sexual function at six months. Comprehensive biopsy follow-up indicates that larger treatment margins than previously thought necessary may be required for complete tumor ablation.

The Journal of urology. 2015 Dec 31 [Epub ahead of print]

Shyam Natarajan, Steven Raman, Alan M Priester, James Garritano, Daniel J A Margolis, Patricia Lieu, Maria L Macairan, Jiaoti Huang, Warren Grundfest, Leonard S Marks

UCLA Department of Urology; UCLA Department of Bioengineering; Center for Advanced Surgical and Interventional Technology. , UCLA Department of Radiology. , UCLA Department of Bioengineering; Center for Advanced Surgical and Interventional Technology. , UCLA Department of Bioengineering; Center for Advanced Surgical and Interventional Technology. , UCLA Department of Radiology. , UCLA Department of Urology. , UCLA Department of Urology. , UCLA Department of Pathology. , UCLA Department of Bioengineering; Center for Advanced Surgical and Interventional Technology. , UCLA Department of Urology; Center for Advanced Surgical and Interventional Technology. 

PubMed

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