Hypofractionated radiotherapy is noninferior to conventional radiotherapy in men with low-risk prostate cancer, yielding no differences in prostate cancer–specific and general quality of life (QoL), as well as in anxiety and depression, according to results from a recent clinical trial (JAMA Oncol. 2019 Feb 14. Epub ahead of print).

“Hypofractionated radiotherapy…would be more convenient for men with low-risk prostate cancer and cost less than conventional radiotherapy…as long as HRT [hypofractionated radiotherapy] is noninferior to CRT [conventional radiotherapy] in terms of survival and…QOL…is not found to be worse,” said Deborah W. Bruner, RN, PhD, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, and colleagues.

Thus, to evaluate the differences in QOL between patients in this population who are treated with hypofractionated radiotherapy versus conventional radiotherapy, Dr Bruner and colleagues conducted a phase 3 clinical trial of 962 men (mean age 66.6 years) with low-risk prostate cancer from the United States, Canada, and Switzerland.

Patients were randomized to undergo conventional radiotherapy of 73.8 Gy in 41 fractions over 8.2 weeks (n = 478) or hypofractionated radiotherapy of 70 Gy in 28 fractions over 5.6 weeks n = 484).

The Expanded Prostate Index Composite questionnaire (which measured bowel, urinary, sexual, and hormonal domains), the 25-item Hopkins Symptom Checklist (which measured anxiety and depression), and the EuroQoL-5 Dimension questionnaire were used to assess QoL. Data were collected at baseline and at 6, 12, 24, and 60 months.

Dr Bruner and colleagues used the Wilcoxon signed rank test to compare change scores between the treatment arms.

“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,” they said.

There were no statistically significant differences observed between the study arms with regard to baseline characteristics and QoL domains. Aside from the hypofractionated radiotherapy arm having a larger decline in the bowel domain at 12 months than the conventional radiotherapy arm (mean score, -7.5 vs -3.7, respectively; P <.001), there were no differences in score changes between the therapy arms with respect to any of the Expanded Prostate Index Composite questionnaire domains; of note, the difference in the bowel domain at 12 months did not reach clinical significance (effect size, 0.29).

Furthermore, there were no differences observed between the study arms with regard to the Hopkins Symptom Checklist and the EuroQoL-5 Dimension questionnaire.

“Treatment with HRT [hypofractionated radiotherapy] is noninferior to CRT [conventional radiotherapy] 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,” Dr Bruner and colleagues said.

“This study provides evidence to affirm that HRT [hypofractionated radiotherapy] is a practice standard for men with low-risk prostate cancer,” they concluded.—Hina Khaliq