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Original Investigation
February 14, 2019

Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial

Author Affiliations
  • 1Winship Cancer Institute, Emory University, Atlanta, Georgia
  • 2NRG Oncology Statistics and Data Management Center, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 3Duke University Medical Center, Durham, North Carolina
  • 4Medical College of Wisconsin, Milwaukee
  • 5University of Chicago, Chicago, Illinois
  • 6Washington University in St Louis, St Louis, Missouri
  • 7University of Texas Health Science Center at San Antonio, San Antonio
  • 8WellSpan York Cancer Center, York, Pennsylvania
  • 9London Regional Cancer Program, London, Ontario, Canada
  • 10Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada
  • 11Kaiser Permanente Northern California, Santa Clara
  • 12Dana-Farber Cancer Institute, Boston, Massachusetts
  • 13Mayo Clinic, Rochester, Minnesota
  • 14University of Rochester, Rochester, New York
  • 15Cedars-Sinai Medical Center, Los Angeles, California
  • 16Henry Ford Hospital, Detroit, Michigan
JAMA Oncol. 2019;5(5):664-670. doi:10.1001/jamaoncol.2018.6752
Key Points

Question  Are there differences in health-related quality of life between men with low-risk prostate cancer who are treated with hypofractionated vs conventional radiotherapy?

Findings  In this phase 3 randomized clinical trial of 962 trial participants, treatment with hypofractionated radiotherapy was found to be noninferior to conventional radiotherapy in men with low-risk prostate cancer in terms of disease-free survival with no differences in prostate cancer–specific (eg, bowel, bladder, sexual) and general quality of life, as well as in anxiety and depression.

Meaning  Level 1 evidence affirms hypofractionated radiotherapy as a new practice standard for men with localized prostate cancer.

Abstract

Importance  Hypofractionated radiotherapy (HRT) would be more convenient for men with low-risk prostate cancer and cost less than conventional radiotherapy (CRT) as long as HRT is noninferior to CRT in terms of survival and quality of life (QOL) is not found to be worse.

Objective  To assess differences in QOL between men with low-risk prostate cancer who are treated with HRT vs CRT.

Design, Setting, and Participants  In this phase 3 randomized clinical trial, men with low-risk prostate cancer were enrolled from sites within the National Cancer Institute’s National Clinical Trials Network in the United States, Canada, and Switzerland.

Interventions  Random assignment to CRT (73.8 Gy in 41 fractions over 8.2 weeks) or to HRT (70 Gy in 28 fractions over 5.6 weeks).

Main Outcomes and Measures  Quality of life was assessed using the Expanded Prostate Index Composite questionnaire measuring bowel, urinary, sexual, and hormonal domains; the 25-item Hopkins Symptom Checklist measuring anxiety and depression; and the EuroQol–5 Dimension questionnaire measuring global QOL. All data were collected at baseline and 6, 12, 24, and 60 months. Change scores were compared between treatment arms using the Wilcoxon signed rank test. A significance level of .0125 to adjust for multiple comparisons was used for an overall 2-sided type 1 error of .05. Clinical significance was determined for the Expanded Prostate Index Composite change scores by an effect size of 0.5.

Results  Of 1092 patients analyzable for the primary end point, 962 (mean [SD] age, 66.6 [7.4] years) consented to the QOL component. No statistically significant differences with regard to baseline characteristics nor any of the QOL baseline domains were measured between arms. There were no differences in change score between arms with respect to any of the Expanded Prostate Index Composite questionnaire domain scores except at 12 months when the HRT arm had a larger decline than the CRT arm in the bowel domain (mean score, −7.5 vs −3.7, respectively; P<.001), but it did not reach clinical significance (effect size = 0.29). There were no differences between arms at any time point for the Hopkins Symptom Checklist nor EuroQol–5 Dimension questionnaire.

Conclusions and Relevance  Treatment with HRT is noninferior to CRT in men with low-risk prostate cancer in terms of disease-free survival and, as shown in the present study, in prostate cancer–specific (eg, bowel, bladder, sexual) and general QOL, as well as in anxiety and depression. This study provides evidence to affirm that HRT is a practice standard for men with low-risk prostate cancer.

Trial Registration  ClinicalTrials.gov identifier: NCT00331773

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