PMID- 29196208
OWN - NLM
STAT- MEDLINE
DCOM- 20190204
LR  - 20190215
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 16
IP  - 2
DP  - 2018 Apr
TI  - eRADicAte: A Prospective Evaluation Combining Radium-223 Dichloride and 
      Abiraterone Acetate Plus Prednisone in Patients With Castration-Resistant 
      Prostate Cancer.
PG  - 149-154
LID - S1558-7673(17)30338-5 [pii]
LID - 10.1016/j.clgc.2017.10.022 [doi]
AB  - BACKGROUND: Multiple castration-resistant prostate cancer (CRPC) therapies are 
      approved by the United States Food and Drug Administration. Radium-223 dichloride 
      (Ra-223) with abiraterone acetate plus prednisone have different mechanisms of 
      action and distinct off-target side-effect profiles. We prospectively 
      investigated their combined safety, tolerability, and patient-reported outcome 
      measures. PATIENTS AND METHODS: eRADicAte, an investigator-initiated, phase II 
      trial, studied 31 patients with metastatic CRPC, from 5 United States 
      uro-oncology research sites. Patients completed 6 cycles of Ra-223 with 
      concurrent abiraterone therapy. Quality of life and pain were assessed using the 
      Functional Assessment of Cancer Therapy-Prostate and the Brief Pain 
      Inventory-Short Form questionnaires and their subscales; we reported the number 
      of subjects meeting standardized criteria for clinically meaningful improvements 
      on each scale. Safety assessment included Eastern Cooperative Oncology Group 
      performance status, laboratory changes, opioid use, radiographic responses, and 
      adverse events (AEs). RESULTS: Twenty of 31 (65%) experienced positive clinically 
      meaningful improvement changes on the Functional Assessment of Cancer 
      Therapy-Prostate, and 25 (81%) of 31 on the Prostate Cancer Subscale. Eighteen 
      (58%) of 31 demonstrated reduced pain intensity and 12 (39%) of 31 demonstrated 
      reduction of pain interference in their lives. At baseline, subjects averaged 
      11.6 +/- 2.8 bone lesions; at the end of treatment, subjects averaged 5.6 +/- 2.4 
      bone lesions (P = .0002). The most frequent AEs were diarrhea (17%), nausea 
      (17%), and fatigue (14%). There were 6 serious AEs; 1 led to study withdrawal. 
      CONCLUSIONS: Patients experienced clinically meaningful improvements in quality 
      of life and pain, without unexpected adverse toxicities. Phase III combination 
      trials of Ra-223 with novel oral hormonal agents are ongoing to further evaluate 
      radiographic progression and overall survival benefit.
CI  - Copyright (c) 2017 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Shore, Neal D
AU  - Shore ND
AD  - Carolina Urologic Research Center, Myrtle Beach, SC. Electronic address: 
      nshore@gsuro.com.
FAU - Tutrone, Ronald F
AU  - Tutrone RF
AD  - Chesapeake Urology Research Associates, Towson, MD.
FAU - Mariados, Neil F
AU  - Mariados NF
AD  - Associated Medical Professionals of New York, Syracuse, NY.
FAU - Nordquist, Luke T
AU  - Nordquist LT
AD  - GU Research Network, Omaha, NE.
FAU - Mehlhaff, Bryan A
AU  - Mehlhaff BA
AD  - Oregon Urology Institute, Springfield, OR.
FAU - Steere, Karyn J
AU  - Steere KJ
AD  - Steere and Associates, LLC, St Paul, MN.
FAU - Harrelson, Stacey S
AU  - Harrelson SS
AD  - Carolina Urologic Research Center, Myrtle Beach, SC.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171107
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Radioisotopes)
RN  - EM5OCB9YJ6 (Abiraterone Acetate)
RN  - RJ00KV3VTG (radium Ra 223 dichloride)
RN  - VB0R961HZT (Prednisone)
RN  - W90AYD6R3Q (Radium)
SB  - IM
MH  - Abiraterone Acetate/*administration & dosage/adverse effects
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prednisone/*administration & dosage/adverse effects
MH  - Prospective Studies
MH  - Prostatic Neoplasms, Castration-Resistant/*therapy
MH  - Quality of Life
MH  - Radioisotopes/administration & dosage/adverse effects
MH  - Radium/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Abiraterone acetate
OT  - Metastatic castrate-resistant prostate cancer
OT  - Pain
OT  - Quality of life
OT  - Radium-223 dichloride
EDAT- 2017/12/03 06:00
MHDA- 2019/02/05 06:00
CRDT- 2017/12/03 06:00
PHST- 2017/10/19 00:00 [received]
PHST- 2017/10/30 00:00 [accepted]
PHST- 2017/12/03 06:00 [pubmed]
PHST- 2019/02/05 06:00 [medline]
PHST- 2017/12/03 06:00 [entrez]
AID - S1558-7673(17)30338-5 [pii]
AID - 10.1016/j.clgc.2017.10.022 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2018 Apr;16(2):149-154. doi: 10.1016/j.clgc.2017.10.022. 
      Epub 2017 Nov 7.