PMID- 30312717
OWN - NLM
STAT- MEDLINE
DCOM- 20190805
LR  - 20220409
IS  - 1879-355X (Electronic)
IS  - 0360-3016 (Print)
IS  - 0360-3016 (Linking)
VI  - 103
IP  - 2
DP  - 2019 Feb 1
TI  - A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for 
      Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG 
      Oncology/RTOG-0526).
PG  - 335-343
LID - S0360-3016(18)33830-6 [pii]
LID - 10.1016/j.ijrobp.2018.09.039 [doi]
AB  - 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.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Crook, Juanita M
AU  - Crook JM
AD  - BC Cancer Agency and University of British Columbia, Kelowna, British Columbia, 
      Canada. Electronic address: jcrook@bccancer.bc.ca.
FAU - Zhang, Peixin
AU  - Zhang P
AD  - NRG Oncology Statistics and Data Management Center, American College of 
      Radiology, Philadelphia, Pennsylvania.
FAU - Pisansky, Thomas M
AU  - Pisansky TM
AD  - Mayo Clinic, Rochester, Minnesota.
FAU - Trabulsi, Edouard J
AU  - Trabulsi EJ
AD  - Jefferson University, Philadelphia, Pennsylvania.
FAU - Amin, Mahul B
AU  - Amin MB
AD  - Cedars-Sinai Medical Center, Los Angeles, California.
FAU - Bice, William
AU  - Bice W
AD  - John Muir Health Systems, Walnut Creek, California.
FAU - Morton, Gerard
AU  - Morton G
AD  - Odette Cancer Center/University of Toronto, Toronto, Ontario, Canada.
FAU - Pervez, Nadeem
AU  - Pervez N
AD  - Cross Cancer Institute, Edmonton, Alberta, Canada.
FAU - Vigneault, Eric
AU  - Vigneault E
AD  - CHU de Quebec Universite Laval, Quebec, Canada.
FAU - Catton, Charles
AU  - Catton C
AD  - University Health Network/University of Toronto, Toronto, Ontario, Canada.
FAU - Michalski, Jeff
AU  - Michalski J
AD  - Washington University, St Louis, Missouri.
FAU - Roach, Mack 3rd
AU  - Roach M 3rd
AD  - University of California, San Francisco, San Francisco, California.
FAU - Beyer, David
AU  - Beyer D
AD  - Arizona Oncology Services Foundation, Sedona, Arizona.
FAU - Jani, Ashesh
AU  - Jani A
AD  - Emory University, Atlanta, Georgia.
FAU - Horwitz, Eric
AU  - Horwitz E
AD  - Fox Chase Cancer Center, Philadelphia, Pennsylvania.
FAU - Donavanik, Viroon
AU  - Donavanik V
AD  - Christiana Care, Newark, Delaware.
FAU - Sandler, Howard
AU  - Sandler H
AD  - Cedars-Sinai Medical Center, Los Angeles, California.
LA  - eng
SI  - ClinicalTrials.gov/NCT00450411
GR  - U10 CA180822/CA/NCI NIH HHS/United States
GR  - U10 CA180868/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
DEP - 20181009
PL  - United States
TA  - Int J Radiat Oncol Biol Phys
JT  - International journal of radiation oncology, biology, physics
JID - 7603616
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
CIN - Transl Androl Urol. 2019 Jul;8(Suppl 3):S232-S235. PMID: 31392131
CIN - Transl Androl Urol. 2019 Jul;8(Suppl 3):S265-S270. PMID: 31392141
MH  - Aged
MH  - Biopsy
MH  - Brachytherapy/*adverse effects/*methods
MH  - Gastrointestinal Tract/*radiation effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Neoplasm Grading
MH  - Neoplasm Recurrence, Local/radiotherapy
MH  - Prospective Studies
MH  - Prostate
MH  - Prostate-Specific Antigen
MH  - Prostatic Neoplasms/*radiotherapy
MH  - Radiotherapy Dosage
MH  - Radiotherapy, Image-Guided/adverse effects/methods
MH  - Salvage Therapy/*adverse effects/*methods
MH  - Treatment Outcome
MH  - Ultrasonography
PMC - PMC6368223
MID - NIHMS1517113
COIS- Conflict of interest statement: Drs. Amin, Beyer, Bice, Crook, Donavanik, 
      Horwitz, Jani, Michalski, Morton, Pisansky, Roach, Trabulski, Vigneault, and 
      Zhang have nothing to disclose. Dr. Catton reports grants from NRG, during the 
      conduct of the study; personal fees from Sanofi Corp, personal fees from Abbvie 
      Corp, personal fees from Bayer Corp, personal fees from Janssen Corp. Dr. Pervez 
      reports grants from Standard Grant per patient from NRG. Dr. Sandler reports 
      grants from ACR-NRG Oncology, during the conduct of the study; personal fees from 
      Ferring, personal fees from Blue Earth Diagnostics, personal fees from Janssen, 
      personal fees from Caribou Publishing.
EDAT- 2018/10/13 06:00
MHDA- 2019/08/06 06:00
PMCR- 2020/02/01
CRDT- 2018/10/13 06:00
PHST- 2018/08/07 00:00 [received]
PHST- 2018/09/17 00:00 [revised]
PHST- 2018/09/28 00:00 [accepted]
PHST- 2018/10/13 06:00 [pubmed]
PHST- 2019/08/06 06:00 [medline]
PHST- 2018/10/13 06:00 [entrez]
PHST- 2020/02/01 00:00 [pmc-release]
AID - S0360-3016(18)33830-6 [pii]
AID - 10.1016/j.ijrobp.2018.09.039 [doi]
PST - ppublish
SO  - 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.