دورية أكاديمية
أعرض في EDS

Randomized Trial of Concomitant Hypofractionated Intensity Modulated Radiation Therapy Boost Versus Conventionally Fractionated Intensity Modulated Radiation Therapy Boost for Localized High-Risk Prostate Cancer (pHART2-RCT).

التفاصيل البيبلوغرافية
العنوان: Randomized Trial of Concomitant Hypofractionated Intensity Modulated Radiation Therapy Boost Versus Conventionally Fractionated Intensity Modulated Radiation Therapy Boost for Localized High-Risk Prostate Cancer (pHART2-RCT).
المؤلفون: Glicksman RM; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Princess Margaret Cancer Centre, University Health Network, Toronto, Canada., Loblaw A; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Morton G; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Vesprini D; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Szumacher E; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Chung HT; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Chu W; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Liu SK; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Tseng CL; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Correa R; London Health Sciences Centre, London, Canada., Deabreu A; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Mamedov A; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Zhang L; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada., Cheung P; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada. Electronic address: patrick.cheung@sunnybrook.ca.
المصدر: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 May 01; Vol. 119 (1), pp. 100-109. Date of Electronic Publication: 2023 Nov 17.
نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase II; Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE
أسماء مطبوعة: Publication: New York, NY : Elsevier, Inc
Original Publication: Elmsford, N. Y., Pergamon Press.
مواضيع طبية MeSH: Prostatic Neoplasms*/radiotherapy , Radiotherapy, Intensity-Modulated*/methods, Male ; Humans ; Prospective Studies ; Androgen Antagonists ; Androgens ; Quality of Life
مستخلص: Purpose: The aim of this work is to report on the results of a phase 2 randomized trial of moderately hypofractionated (MH) versus conventionally fractionated (CF) radiation therapy to the prostate with elective nodal irradiation.
Methods and Materials: This was a single-center, prospective, phase 2 randomized study. Patients with high-risk disease (cT3, prostate-specific antigen level >20 ng/mL, or Gleason score 8-10) were eligible. Patients were randomized to either MH using a simultaneous integrated boost (68 Gy in 25 fractions to prostate; 48 Gy to pelvis) or CF (46 Gy in 23 fractions with a sequential boost to the prostate of 32 Gy in 16 fractions), with long-term androgen deprivation therapy. The primary endpoint was grade ≥2 acute gastrointestinal (GI) and genitourinary (GU) toxicity (Common Terminology Criteria for Adverse Events version 3.0). Secondary endpoints included late GI and GU toxicity, quality of life, and oncologic outcomes.
Results: One-hundred eighty patients were enrolled; 90 were randomized to and received MH and 90 to CF. The median follow-up was 67.4 months. Seventy-five patients (41.7%) experienced a grade ≥2 acute GI and/or GU toxicity, including 34 (37.8%) in the MH and 41 (45.6%) in the CF arms, respectively (P = .29). Late grade ≥2 GI (P = .07) and GU (P = .25) toxicity was not significantly different between arms; however, late grade ≥3 GI toxicity was worse in the MH group (P = .01). There were no statistically significant quality-of-life differences between the 2 treatments. There were no statistically significant differences observed in cumulative incidence of biochemical failure (P = .71) or distant metastasis (P = .31) and overall survival (P = .46).
Conclusions: MH to the prostate and pelvis with androgen deprivation therapy for men with high-risk localized prostate cancer was not significantly different than CF with regard to acute toxicity, quality of life, and oncologic efficacy. However, late grade ≥3 GI toxicity was more common in the MH arm.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
المشرفين على المادة: 0 (Androgen Antagonists)
0 (Androgens)
تواريخ الأحداث: Date Created: 20231118 Date Completed: 20240419 Latest Revision: 20240419
رمز التحديث: 20240419
DOI: 10.1016/j.ijrobp.2023.11.006
PMID: 37979707
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-355X
DOI:10.1016/j.ijrobp.2023.11.006