Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial.

UNLABELLED: Study Type--Therapy (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Patient-reported quality of life (QoL) in prostate cancer is recognized as an important outcome, and has been shown in multiple studies to capture the incidence and timing of patient symptoms more accurately than physician-graded toxicity reports. Although the long-term QoL after completing radiation therapy (RT) has been previously studied, patient experience during RT is not well described in the literature. The present study collected patient-reported QoL during RT in a prospective phase II clinical trial. The study describes in detail the time course and severity of gastrointestinal and genitourinary symptoms during radiation, providing clinically useful information for patients and physicians considering RT during the treatment decision-making process. OBJECTIVE: • To evaluate data collected from a phase II trial to describe the time course and trajectory of patient-reported acute urinary and bowel symptom development during radiation therapy (RT) for prostate cancer. PATIENTS AND METHODS: • In all, 100 patients with intermediate- or high-risk prostate cancer received 72 Gy of RT to the prostate and seminal vesicles, with 6 months of concurrent androgen deprivation therapy; a rectal balloon was used for prostate immobilization. • Patients completed the validated Prostate Cancer Symptom Indices questionnaire every 1-2 weeks, reporting urinary and bowel symptoms on a four- or five-point Likert scale. • A score of ≥ 3 in a symptom is associated with clinically meaningful distress. Cumulative incidence of each symptom is reported. Bonferroni corrections of P values were used to adjust for multiple comparisons. RESULTS: • Urinary symptoms were frequent at baseline and worsened during treatment. By the end of RT, 28-50% of patients developed clinically meaningful obstructive and irritative urinary symptoms. • Acute bowel symptoms were less frequent. Each bowel symptom increased in frequency by 9-26% from baseline to end of RT. • Urinary incontinence was rare. • Overall, symptom burden at the end of treatment was modest. CONCLUSIONS: • Urinary symptoms were common during RT, and bowel symptoms were less frequent. • These results inform patients and physicians during the decision-making process about potential patient quality of life experiences during RT, and also provide a benchmark for comparative effectiveness studies against newer treatments and technologies.

Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study.

BACKGROUND: Patient-reported quality of life (QOL) after salvage brachytherapy for radiorecurrent prostate cancer has not been well-characterized prospectively. METHODS: We examined 25 men who recurred after primary radiotherapy for prostate cancer and received MRI-guided salvage brachytherapy as part of a prospective Phase II study. These patients received prospectively a validated patient-reported QOL questionnaire to fill out at baseline, as well as 3, 15, and 27 months after re-irradiation to determine the degree of sexual, bowel, and urinary dysfunction (maximum dysfunction score=100). RESULTS: On average, sexual function continued to decline with time, and patients had significantly worse sexual function scores at 27 months than baseline (p=0.01). Although bowel and urinary symptoms worsened acutely at 3 or 15 months, they showed on average some improvement by 27 months, and there were no significant differences between baseline and 27-month urinary or bowel scores. An interval to re-irradiation less than 4.5 years and prior brachytherapy were each associated significantly with the largest decrements in bowel function (p=0.035). CONCLUSION: Similar to the patterns seen in the de novo setting, patients who receive salvage brachytherapy report a worsening of bowel and urinary symptoms followed by some improvement by 27 months, while sexual function steadily declines over time. Interval to re-irradiation and type of prior radiation received may be used to counsel and optimize selection of men for salvage brachytherapy with regard to QOL endpoints.