Mp30-06 Interim Follow up of a Phase Ii Trial of Mri-ultrasound Fusion Biopsy Guided Prostate Cancer (pca) Focal Therapy by Bipolar Radiofrequency Ablation
Year: 2018
Type: article
Abstract: You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I1 Apr 2018MP30-06 INTERIM FOLLOW UP OF A PHASE II TRIAL OF MRI-ULTRASOUND FUSION BIOPSY GUIDED PROSTATE CANCER (PCA) FOCAL THERAPY BY BIPOLAR RADIOFREQUENCY ABLATION Samir S Taneja, Benjamin Press, Richard Huang, Fang-Ming Deng, and Andrew Rosenkrantz Samir S TanejaSamir S Taneja More articles by this author , Benjamin PressBenjamin Press More articles by this author , Richard HuangRichard Huang More articles by this author , Fang-Ming DengFang-Ming Deng More articles by this author , and Andrew RosenkrantzAndrew Rosenkrantz More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.947AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Focal therapy (FT) for PCa requires balance between treatment margin and functional preservation. To date, utilized energy sources lack the ability to precisely define the borders of ablation in real time risking undertreatment, and are limited by thermal energy dispersion. We report the outcomes of FT using a novel bipolar radiofrequency ablation (bRFA) device guided by results of MRI-ultrasound fusion-targeted biopsy (MRF-TB). METHODS Between 8/1/14 and 9/15/15, 21 men with limited focality PCa were enrolled in a Phase II trial of FT (clinicaltrials.gov # NCT02303054) if stage ≤T2a, PSA <10, mpMRI with ≤ 2 MRI suspicious regions (mSR) of suspicion score ≥ 3, MRF-TB with GS ≤ 7(3+4) PCa in mSR, and systematic biopsy (SB) with PCa spatially concordant with MRF-TB. 10 or 12 mm bRFA coils (Encage TM, Trod Medical, St Petersburg, FL) were placed with goal of 10 mm intra-, 3 mm extra-prostatic treatment margin. Follow-up included postop day (POD) 7 and 6 month MRI and 6 month MRF-TB/SB in all men, and additional PSA, MRI, biopsy in men successfully treated. Residual cancer was defined as in field, in margin (target adjacent), out of field. Adverse events (AE), quality of life (FACT-P,SHIM, IPSS) outcomes were assessed. RESULTS 21 men (Mean age 63.9. Mean baseline PSA 5.1) completed treatment and follow-up biopsy. bRFA was conducted in 1 (n=15) or 2 (n=6) mSR. POD 7 MRI suggested complete ablation of tumor in 19/21 men. Abnormal 6 mo. MRI was noted in 10 cases as likely due to tumor (4) or treatment effect (6). On comparing MRI with the 6 month biopsy, MRI was not a significant predictor of residual PCa (χ(2) = 5.162, p =.076). Negative biopsy in the treated zone was noted in 16/21 (76%) men and 20/25 (80%) lesions. Residual PCa (n=14) was noted in field in 5 (24%), in margin in 6 (28%), and out of field in 7 (33%) men. 4/14 men remain on surveillance, 8/14 underwent re-treatment, 2 were lost to follow up. 0/15 and 1/9 men who underwent 18 and 30 month MRI, respectively, demonstrated progression. After initial decline from baseline to 6 months, PSA remained stable through 24 months. AE were rare, mild and transient. No relationship between SF-12 (F(1.759, 26.690) = 2.428, p<.113), IPSS(F(1.667, 26.669) = 1.293, p<.286), SHIM(F(2, 32) = 0.72, p<.931) and treatment was seen. CONCLUSIONS Focal bRFA is a novel highly targeted method of focal ablation. Target tumor clearance was achieved in 76% of men, with short-term durable control among those successfully treated, but residual PCa was noted in the region of the ablation in 43%, suggesting need for improved margin control. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e376 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Samir S Taneja More articles by this author Benjamin Press More articles by this author Richard Huang More articles by this author Fang-Ming Deng More articles by this author Andrew Rosenkrantz More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...
Source: The Journal of Urology
Authors: Samir S Taneja, Benjamin Press, Richard Huang, Fang-Ming Deng, Andrew Rosenkrantz
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2796359416