Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial

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.

Trial registration: ClinicalTrials.gov NCT00002633.

Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

© 2015 by American Society of Clinical Oncology.

Figures

Fig 1.

Health-related quality-of-life (HRQOL) data collection schema and compliance rates for each HRQOL instrument. EORTC, European Organisation for Research and Treatment of Cancer; FACT-P, Functional Assessment of Cancer Therapy–Prostate questionnaire; MRC, Medical Research Council; R, radiotherapy.

Fig 2.

Health-related quality-of-life (QOL) function scores over time for physical well-being (PWB). Higher scores represent better function (higher QOL). Scores collected with (A) Functional Assessment of Cancer Therapy–Prostate questionnaire (FACT-P) and (B) European Organisation for Research and Treatment of Cancer (EORTC) Core Questionnaire. FACT-P scores are truncated after 4 years because of declined compliance thereafter. Mean score number is simple average at each time point, with point-wise 95% CI. ADT, androgen-deprivation therapy; RT, radiotherapy.

Fig 3.

Mean symptom scores over time by treatment arm for symptoms typically associated with radiotherapy. Lower scores represent fewer symptoms. Mean score number is simple average at each time point, with point-wise 95% CI. (A) Functional Assessment of Cancer Therapy–Prostate questionnaire (FACT-P) urinary score; (B) European Organisation for Research and Treatment of Cancer (EORTC) Core Questionnaire bowel and rectum score; (C) EORTC diarrhea score; (D) FACT-P erectile dysfunction score. ADT, androgen-deprivation therapy.

Fig 4.

Stacked bars represent proportion of men improving, worsening, or remaining stable at any time (compared with baseline) for (A) health-related quality-of-life bowel and bladder symptom domains and (B) general symptom domains. ADT, androgen-deprivation therapy; XRT, radiotherapy.

Fig 5.

Stacked bars represent proportions of men with nonzero toxicity grades (1 to 4) or nonzero health-related quality-of-life (HRQOL) response categories. (A) Toxicity categories that best correspond to items reported on (B) HRQOL domains. ADT, androgen-deprivation therapy; XRT, radiotherapy.

Fig A1.

Functional Assessment of Cancer Therapy–Prostate questionnaire (FACT-P) (A) overall mean total scores over time and (B) mean trial outcome index (TOI) scores over time. ADT, androgen-deprivation therapy; RT, radiotherapy.

Fig A2.

(A) Functional Assessment of Cancer Therapy–Prostate questionnaire functional well-being (FWB) mean function scores over time and (B) European Organisation for Research and Treatment of Cancer (EORTC) Core Questionnaire role domain mean function scores over time. ADT, androgen-deprivation therapy; RT, radiotherapy.