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A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526)
| Content Provider | Scilit |
|---|---|
| Author | 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 Beyer, David Jani, Ashesh Horwitz, Eric Donavanik, Viroon Sandler, Howard |
| Copyright Year | 2018 |
| Description | Journal: International Journal of Radiation Oncology - Biology - Physics Purpose Only retrospective data are available for low-dose-rate (LDR) salvage prostate brachytherapy for local recurrence after external beam radiation therapy (EBRT). The primary objective of this prospective phase 2 trial (NCT00450411) was to evaluate late gastrointestinal and genitourinary adverse events (AEs) after salvage LDR brachytherapy. Methods and Materials Eligible patients had low- or intermediate-risk prostate cancer before EBRT and biopsy-proven recurrence >30 months after EBRT, with prostate-specific antigen levels <10 ng/mL and no regional/distant disease. The primary endpoint was grade 3 or higher late treatment-related gastrointestinal or genitourinary AEs occurring 9 to 24 months after brachytherapy. These AEs were projected to be ≤10%, with ≥20% considered unacceptable. All events were graded with National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Multivariate analyses investigated associations of pretreatment or treatment variables with AEs. Results One hundred patients from 20 centers were registered from May 2007 to January 2014. The 92 analyzable patients had a median follow-up of 54 months (range, 4-97) and a median age of 70 years (interquartile range [IQR], 65-74). The initial Gleason score was 7 in 48% of patients. The 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 gastrointestinal/genitourinary AEs, with no treatment-related grade 4 or 5 AEs. No pretreatment variable predicted late AEs, including prior EBRT dose and elapsed interval. Higher V100 (percentage of prostate enclosed by prescription isodose) predicted both occurrence of late AEs (odds ratio, 1.24; 95% confidence interval, 1.02-1.52; P = .03) and earlier time to first occurrence (hazard ratio, 1.18; 95% CI, 1.03-1.34; P = .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-year follow-up. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368223/pdf http://www.redjournal.org/article/S0360301618338306/pdf |
| Ending Page | 343 |
| Page Count | 9 |
| Starting Page | 335 |
| ISSN | 03603016 |
| DOI | 10.1016/j.ijrobp.2018.09.039 |
| Journal | International Journal of Radiation Oncology - Biology - Physics |
| Issue Number | 2 |
| Volume Number | 103 |
| Language | English |
| Publisher | Elsevier BV |
| Publisher Date | 2019-02-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: International Journal of Radiation Oncology - Biology - Physics Radiology, Nuclear Medicine and Imaging Prostate Cancer Salvage Low Dose Rate Brachytherapy External Beam Radiotherapy Failure |
| Content Type | Text |
| Resource Type | Article |
| Subject | Radiology, Nuclear Medicine and Imaging Cancer Research Radiation Oncology |
