Pd56-08 the Part Trial - A Phase Iii Study Comparing Partial Prostate Ablation Versus Radical Prostatectomy (Part) in Intermediate Risk Prostate Cancer – Early Data From the Feasibility Study

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy II1 Apr 2017PD56-08 THE PART TRIAL - A PHASE III STUDY COMPARING PARTIAL PROSTATE ABLATION VERSUS RADICAL PROSTATECTOMY (PART) IN INTERMEDIATE RISK PROSTATE CANCER – EARLY DATA FROM THE FEASIBILITY STUDY Tom Leslie, Lucy Davies, Daisy Elliott, Simon Brewster, Prasanna Sooriakumaran, Derek Rosario, Jim Catto, Tim Dudderidge, Hashim Ahmed, Mark Emberton, Richard Hindley, Jenny Donovan, Richard Gray, and Freddie Hamdy Tom LeslieTom Leslie , Lucy DaviesLucy Davies , Daisy ElliottDaisy Elliott , Simon BrewsterSimon Brewster , Prasanna SooriakumaranPrasanna Sooriakumaran , Derek RosarioDerek Rosario , Jim CattoJim Catto , Tim DudderidgeTim Dudderidge , Hashim AhmedHashim Ahmed , Mark EmbertonMark Emberton , Richard HindleyRichard Hindley , Jenny DonovanJenny Donovan , Richard GrayRichard Gray , and Freddie HamdyFreddie Hamdy View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2597AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Recent findings from the ProtecT trial suggest that survival in clinically localised prostate cancer is very high, and that radical treatments half the incidence of metastatic disease progression but at the cost of significant side effects. Using minimally invasive technology, such as HIFU or cryotherapy, for partial gland ablation (PA) could reduce these side effects. Partial prostate Ablation versus Radical prostatectomy (PART trial) is the first phase III study to compare PA and radical surgery (RP) in intermediate risk prostate cancer. PART is a prospective, multi-centre, parallel group randomised controlled trial to assess the clinical effectiveness and cost-utility of PA or RP in patients with intermediate risk, unilateral clinically significant localised prostate cancer. Our hypothesis is that PA of the prostate using minimally invasive therapies can achieve organ preservation, reduce side effects, maintain good voiding and sexual function, without compromise to oncological outcomes. We report the outcomes of our successful feasibility study which will now drive the establishment of the main multi-centre randomised controlled trial. METHODS Participants were eligible when diagnosed with intermediate risk, unilateral clinically significant localised prostate cancer, fit for either RP or PA. Pre-biopsy mpMRI and targeted biopsy or template guided biopsies were compulsory before randomization to either RP or PA. Target accrual for the feasibility phase was 80 patients over 18 months. Follow-up involved regular PSA measurements and, in the focal therapy arm, mpMRI and targeted biopsies of any suspicious areas. Quality of life data were measured at six weeks and three monthly intervals. RESULTS The table below summarises recruitment data. Baseline demographics of men randomised to date are Mean age: 66.7yrs (48.4-78.2); BMI: 26.4 (22.0-32.3); PSA: 7.60 (2.5-16.20) and Gleason score: 3+4=7 75.6%, 4+3=7 24.4%. CONCLUSIONS A randomised controlled trial of partial ablation of the prostate versus radical treatment with surgery is feasible. The full trial is being developed, and will provide key data to inform men when making the treatment decision for intermediate risk unilateral prostate cancer. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1118-e1119 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Tom Leslie More articles by this author Lucy Davies More articles by this author Daisy Elliott More articles by this author Simon Brewster More articles by this author Prasanna Sooriakumaran More articles by this author Derek Rosario More articles by this author Jim Catto More articles by this author Tim Dudderidge More articles by this author Hashim Ahmed More articles by this author Mark Emberton More articles by this author Richard Hindley More articles by this author Jenny Donovan More articles by this author Richard Gray More articles by this author Freddie Hamdy More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...