FOLLOW UP RESULTS FROM A SINGLE CENTER PHASE I TRIAL Sherif Mehralivand*, Bethesda, MD; Arvin George, Ann Arbor, MI; Anthony Hoang, Houston, TX; Soroush Rais-Bahrami, Birmingham, AL; Ardeshir Rastinehad, New York, NY; Vladimir Valera Romero, Jonathan Bloom, Samuel Gold, Graham Hale, Kareem Rayn, Marcin Czarniecki, Clayton Smith, Stephanie Harmon, Maria Merino, Peter Choyke, Baris Turkbey, Bradford Wood, Peter Pinto, Bethesda, MD INTRODUCTION AND OBJECTIVES: Patients with low and intermediate risk prostate cancer (PCa) are at increased risk of overtreatment. Focal therapy aims to treat PCa lesions while preserving quality of life. We present the functional and oncological follow up data of a phase I trial of multiparametric magnetic resonance imaging (mpMRI) – guided focal laser ablation therapy (FLA). METHODS: Inclusion criteria were mpMRI visible, organ confined PCa (cT2a), Gleason score 3+4 in 3 cores in standard 12 core biopsy (Sx) or ¼ 4 cores on mpMRI guided biopsy (Tx). The procedures were done under general anesthesia, in-gantry via transperineal approach using the Visualase system which utilizes a 1cm optical fiber with a 980nm diode laser surrounded by a cooling catheter inserted through a 14-gauge catheter. Primary outcome was safety and toxicity expressed as lack of grade 3 complications and change in IPSS and SHIM scores. Secondary outcomes were changes in post-treatment PSA and Gleason score. Patients were followed up for 3, 6, 9, 12, 18, 24 and 36 months with clinical evaluation, PSA, IPSS and SHIM scores. RESULTS: 15 patients were included. Median age, PSA, IPSS and SHIM were 66 years, 6.19ng/ml, 6 and 20, respectively. Median follow-up time was 40.5 months. Nine patients had Gleason 3+4 and 6 had Gleason 3+3 cancer. All patients tolerated the procedure well with no grade 3 complications. 4 patients had grade 2 complications (n=2 urinary tract infection, n=1 worsening lower urinary tract symptoms, n=1 bilateral epididymitis. 8 patients had grade 1 complications (n=5 gross hematuria, n=3 minor grade 1 complaints e.g. urgency, small pressure ulcer, postoperative fever). All events resolved completely. Follow up targeted biopsy revealed no evidence of cancer in n=10 patients, whereas in 5 patients follow up biopsy was positive (n=3 had 2nd FLA session, n=2 underwent prostatectomy). Median ( SD) PSA at last follow-up (4.79 3.32) was significantly lower than prior to treatment (6.19 3.76) (p=0.002). There was no significant difference between pre-treatment IPSS (6 3.9), SHIM (20 7.17) and posttreatment IPSS (6 7.58), SHIM (17.13 8.28) (p=0.86 and p=0.54, respectively).
CONCLUSIONS: mpMRI guided FLA is safe and feasible without any significant change in urinary and sexual function with reasonable oncologic results.
Source of Funding: The author0 s postdoctoral fellowship is funded by a research grant from the Dr. Mildred Scheel foundation (Bonn, Germany)The research in this study was funded by the Intramural Research Program of the National Institutes of HealthSupported by the Center for Interventional Oncology (NIH grant #ZID BC 011242), the Intramural Research Program of the NIH, and the NCI. NIH and Philips / InVivo have a Cooperative Research & Development Agreement. NIH owns intellectual property in the field and NIH and Philips / InVivo have a licensing agreement.Funded by the NCI Contract No. HHSN261200800001E
Source: THE JOURNAL OF UROLOGY