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[Abstract]

PURPOSE:

The NCIC CTG PR3/MRC PR07 randomized phase III trial compared androgen-deprivation therapy (ADT) alone versus ADT with radiotherapy (RT) for patients with locally advanced prostate cancer. This article reports the health-related quality-of-life (HRQOL) outcomes of this trial.

PATIENTS AND METHODS:

A total of 1,205 patients were randomly allocated to either ADT alone or ADT with RT. HRQOL was assessed at baseline and every 6 months thereafter using the European Organisation for Research and Treatment of Cancer Core Questionnaire and a prostate cancer-specific checklist or the Functional Assessment of Cancer Therapy-Prostate questionnaire. Mean changes from baseline scores for five function domains and nine symptom domains were analyzed as those most relevant to ADT and RT. The proportions of patients with improved, stable, or worsened HRQOL scores according to instrument-specific minimal important differences were calculated.

RESULTS:

Baseline questionnaires were completed by 1,028 patients (88%). At 6 months, RT had a statistically significant impact on mean score for bowel symptoms (P = .02), diarrhea (P < .001), urinary function (P = .003), and erectile dysfunction (P = .008); by 3 years, however, there were no significant between-group differences in any domain. Generalized linear mixed modeling revealed no significant between-arm differences in any of the function scales but showed significant deterioration in both arms over time for Functional Assessment of Cancer Therapy-Prostate total score, treatment outcome index, and physical and functional well-being.

CONCLUSION:

The addition of RT to ADT for patients with locally advanced prostate cancer significantly improved overall survival and had only modest and transient negative impact on relevant domains of HRQOL.

​[Author information]

Brundage M1, Sydes MR2, Parulekar WR2, Warde P2, Cowan R2, Bezjak A2, Kirkbride P2, Parliament M2, Moynihan C2, Bahary JP2, Parmar MK2, Sanders K2, Chen BE2, Mason MD2.

1Michael Brundage, Queen's Cancer Research Institute and Cancer Centre of Southeastern Ontario; Wendy R. Parulekar and Bingshu E. Chen, NCIC Clinical Trials Group, Queen's University, Kingston; Padraig Warde and Andrea Bezjak, Princess Margaret Cancer Center, Toronto, Ontario; Matthew Parliament, Cross Cancer Institute, Edmonton, Alberta; Jean-Paul Bahary, Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, Quebec, Canada; Matthew R. Sydes, Mahesh K.B. Parmar, and Karen Sanders, Medical Research Council Clinical Trials Unit, University College London, London; Richard Cowan, Christie Hospital and University of Manchester, Manchester; Peter Kirkbride, Clatterbridge Cancer Centre, National Health Service Foundation Trust, Wirral; Clare Moynihan, Institute of Cancer Research, Sutton; and Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital, Cardiff, United Kingdom. michael.brundage@krcc.on.ca.

2Michael Brundage, Queen's Cancer Research Institute and Cancer Centre of Southeastern Ontario; Wendy R. Parulekar and Bingshu E. Chen, NCIC Clinical Trials Group, Queen's University, Kingston; Padraig Warde and Andrea Bezjak, Princess Margaret Cancer Center, Toronto, Ontario; Matthew Parliament, Cross Cancer Institute, Edmonton, Alberta; Jean-Paul Bahary, Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, Quebec, Canada; Matthew R. Sydes, Mahesh K.B. Parmar, and Karen Sanders, Medical Research Council Clinical Trials Unit, University College London, London; Richard Cowan, Christie Hospital and University of Manchester, Manchester; Peter Kirkbride, Clatterbridge Cancer Centre, National Health Service Foundation Trust, Wirral; Clare Moynihan, Institute of Cancer Research, Sutton; and Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital, Cardiff, United Kingdom.