Mp61-16 initial clinical trial of focal laser ablation utilising profocal-r® for localised prostate cancer

You have accessJournal of UrologyCME1 Apr 2023MP61-16 INITIAL CLINICAL TRIAL OF FOCAL LASER ABLATION UTILISING PROFOCAL-R® FOR LOCALISED PROSTATE CANCER Jonathan Kam, George McClintock, Josh Makary, Stuart Jackson, Bishoy Hanna, Alice Grant, Jake Rahkala, Mohan Arianayagam, Bertram Canagasingham, Richard Ferguson, Ahmed Goolam, Matthew Winter, Nicola Jeffery, Raymond Ko, Nicholas Mehan, Mohamed Khadra, Isaac Thangasamy, and Celi Varol Jonathan KamJonathan Kam More articles by this author , George McClintockGeorge McClintock More articles by this author , Josh MakaryJosh Makary More articles by this author , Stuart JacksonStuart Jackson More articles by this author , Bishoy HannaBishoy Hanna More articles by this author , Alice GrantAlice Grant More articles by this author , Jake RahkalaJake Rahkala More articles by this author , Mohan ArianayagamMohan Arianayagam More articles by this author , Bertram CanagasinghamBertram Canagasingham More articles by this author , Richard FergusonRichard Ferguson More articles by this author , Ahmed GoolamAhmed Goolam More articles by this author , Matthew WinterMatthew Winter More articles by this author , Nicola JefferyNicola Jeffery More articles by this author , Raymond KoRaymond Ko More articles by this author , Nicholas MehanNicholas Mehan More articles by this author , Mohamed KhadraMohamed Khadra More articles by this author , Isaac ThangasamyIsaac Thangasamy More articles by this author , and Celi VarolCeli Varol More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003319.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: ProFocal-Rx™ (Medlogical Innovations, Sydney, Australia) is a novel, day-only, fast focal laser ablation treatment for prostate cancer. It is performed via a transperineal route and can be utilised with an MRI/US fusion targeting platform. Compared to other focal therapies available it provides precise tissue ablation with very minimal energy spread to surrounding tissues. We aimed to evaluate the interim outcomes of this novel treatment for localised prostate cancer. METHODS: A prospective trial was performed following institutional review board evaluating day only, fast, focal laser ablation for localised prostate cancer using the novel ProFocal-Rx™ device (Medlogical Innovations, Sydney, Australia) at Nepean Hospital, Australia. Inclusion criteria included men with prostate cancer with PSA≤15 ng/ml, stage≤T2c, ISUP 2-3, and 1-2 MRI visible lesions which were concordant with biopsy results. A post treatment MRI was performed within 72 hours to confirm adequacy of tissue ablation. Patients then had a 3-month follow-up transperineal prostate biopsy to assess treatment outcomes. RESULTS: The interim, non validated data for the 100 men recruited for this trial who underwent focal laser ablation and had a minimum of 3 months follow-up were included in the analysis. The median age was 69, PSA 6ng/ml (range 0.7-15) and MRI lesion volume 0.82cc (range 0.12-3.76). All cases were completed as day only procedures and there were no readmissions to hospital. On the 3 month follow-up biopsy, 75% of patients had no evidence of ISUP 2 or greater prostate cancer on any of their biopsies. 12% of cases proceeded to salvage robotic radical prostatectomy and 2% underwent salvage radiotherapy. 40% of cases with ISUP 2 prostate cancer on the 3-month biopsy were placed under active surveillance due to the small volume of cancer detected on these biopsies. Of the cases who underwent salvage robotic prostatectomy there was no significant difference in their outcomes compared to our contemporary cohort with nerve sparing achievable for cases and a median blood loss of 250ml. Patient reported functional outcomes were excellent with no significant worsening in quality-of-life scores (SF-12), lower urinary tract symptoms (IPSS, EPIC- urinary domains) or sexual function (SHIM and EPIC-sexual domains) between the pre-op, 3-month or 6-month assessment CONCLUSIONS: The interim results from the ProFocal-Rx™ focal laser ablation trial are promising with 85% of patients avoiding radical treatment. For patients requiring salvage surgery there appears to be no increase in adverse outcomes due to prior focal treatment. Functional outcomes are excellent with no worsening in any patient reported outcomes post treatment. Source of Funding: Medlogical Innovations sponsored this study © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e859 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jonathan Kam More articles by this author George McClintock More articles by this author Josh Makary More articles by this author Stuart Jackson More articles by this author Bishoy Hanna More articles by this author Alice Grant More articles by this author Jake Rahkala More articles by this author Mohan Arianayagam More articles by this author Bertram Canagasingham More articles by this author Richard Ferguson More articles by this author Ahmed Goolam More articles by this author Matthew Winter More articles by this author Nicola Jeffery More articles by this author Raymond Ko More articles by this author Nicholas Mehan More articles by this author Mohamed Khadra More articles by this author Isaac Thangasamy More articles by this author Celi Varol More articles by this author Expand All Advertisement PDF downloadLoading ...