Skip to main content

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

Publication ,  Journal Article
Bruner, DW; Pugh, SL; Lee, WR; Hall, WA; Dignam, JJ; Low, D; Swanson, GP; Shah, AB; Malone, S; Michalski, JM; Dayes, IS; Seaward, SA; Chen, Y ...
Published in: JAMA Oncol
May 1, 2019

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JAMA Oncol

DOI

EISSN

2374-2445

Publication Date

May 1, 2019

Volume

5

Issue

5

Start / End Page

664 / 670

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Risk
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy, Conformal
  • Quality of Life
  • Prostatic Neoplasms
  • Male
  • Humans
  • Disease-Free Survival
  • Aged
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Bruner, D. W., Pugh, S. L., Lee, W. R., Hall, W. A., Dignam, J. J., Low, D., … Movsas, B. (2019). Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol, 5(5), 664–670. https://doi.org/10.1001/jamaoncol.2018.6752
Bruner, Deborah W., Stephanie L. Pugh, W Robert Lee, William A. Hall, James J. Dignam, Daniel Low, Gregory P. Swanson, et al. “Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial.JAMA Oncol 5, no. 5 (May 1, 2019): 664–70. https://doi.org/10.1001/jamaoncol.2018.6752.
Bruner, Deborah W., et al. “Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial.JAMA Oncol, vol. 5, no. 5, May 2019, pp. 664–70. Pubmed, doi:10.1001/jamaoncol.2018.6752.
Bruner DW, Pugh SL, Lee WR, Hall WA, Dignam JJ, Low D, Swanson GP, Shah AB, Malone S, Michalski JM, Dayes IS, Seaward SA, Nguyen PL, Pisansky TM, Chen Y, Sandler HM, Movsas B. Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):664–670.

Published In

JAMA Oncol

DOI

EISSN

2374-2445

Publication Date

May 1, 2019

Volume

5

Issue

5

Start / End Page

664 / 670

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Risk
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy, Conformal
  • Quality of Life
  • Prostatic Neoplasms
  • Male
  • Humans
  • Disease-Free Survival
  • Aged