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Crook JM , Zhang P , Pisansky TM , Trabulsi EJ , Amin MB , Bice W , Morton G , Pervez N , Vigneault E , Catton C , Michalski J , Roach M 3rd , Beyer D , Jani A , Horwitz E , Donavanik V , Sandler H
A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526)
Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2) :335-343
PMID: 30312717    PMCID: PMC6368223    URL: https://www.ncbi.nlm.nih.gov/pubmed/30312717
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PURPOSE: Only retrospective data is available for low dose rate (LDR) salvage prostate brachytherapy for local recurrence after external beam radiotherapy (EBRT). The primary objective of this prospective Phase II trial (NCT00450411) was to evaluate late gastrointestinal and genitourinary adverse events (AEs) after salvage LDR brachytherapy. MATERIALS/METHODS: Eligible patients had low/intermediate risk prostate cancer prior to EBRT and biopsy-proven recurrence >30 months after EBRT, with PSA <10 ng/mL and no regional/distant disease. The primary endpoint was grade 3 or higher late treatment-related GI/GU AEs occurring 9-24 months after brachytherapy. These were projected to be <10%, with >20% considered unacceptable. All events were graded with CTCAE V3.0. Multivariate analyses investigated associations of pre-treatment or treatment variables with AEs. RESULTS: From May 2007 to January 2014, 100 patients were registered from 20 centers. 92 analyzable patients had a median follow-up of 54 months (range: 4-97) and median age 70 (IQR: 65-74). Initial Gleason score was 7 in 48%. Median dose of EBRT was 74 Gy (IQR: 70-76) at a median interval of 85 months previously (IQR: 60-119). Only 16% had androgen deprivation at study entry. Twelve patients (14%) had late grade 3 GI/GU AEs with no treatment-related grade 4 or 5 AEs. No pre-treatment variable predicted late AEs, including prior EBRT dose and elapsed interval. Higher V100 (% of prostate enclosed by prescription isodose) predicted both occurrence of late AEs (OR=1.24; 95% CI: 1.02-1.52; p=0.03) and earlier time to first occurrence (HR=1.18; 95% CI: 1.03-1.34; p=0.02). CONCLUSIONS: This prospective multicenter trial reports outcomes of salvage LDR brachytherapy for post EBRT recurrence. The rate of late grade 3 AEs did not exceed the unacceptable threshold. The only factor predictive of late AEs was implant dosimetry reflected by V100. Efficacy outcomes will be reported at a minimum of 5-yr follow-up.
1879-355x Crook, Juanita M Zhang, Peixin Pisansky, Thomas M Trabulsi, Edouard J Amin, Mahul B Bice, William Morton, Gerard Pervez, Nadeem Vigneault, Eric Catton, Charles Michalski, Jeff Roach, Mack 3rd Beyer, David Jani, Ashesh Horwitz, Eric Donavanik, Viroon Sandler, Howard U10 CA180822/CA/NCI NIH HHS/United States U10 CA180868/CA/NCI NIH HHS/United States Journal Article United States Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.