Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial

Abstract

Background: For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic androgen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we evaluated qualityof-life (QOL) parameters in patients with metastatic prostate cancer who were randomly assigned to two methods of androgen deprivation. Methods: Patients (n = 739) with stage M 1 (bone or soft tissue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized doubleblind trial comparing treatment with bilateral orchiectomy (surgical castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to treatment and at 1, 3, and 6 months later. Data were collected on three treatment-specific symptoms (diarrhea, gas pain, and body image), on physical functioning, and on emotional functioning. All P values are two-sided. Results: Questionnaire return rates for this study never dropped below 80%; only 2% of the patients did not submit baseline QOL assessments. Cross-sectional analyses (corrected for multiple testing) identified statistically significant differences that favored orchiectomy plus placebo for two of the five primary QOL parameters as follows: patients receiving flutamide reported more diarrhea at 3 months (P = .001) and worse emotional functioning at 3 and 6 months (both P<.003). Longitudinal analyses replicated these findings. Other analyzed QOL parameters favored the group receiving placebo but were not statistically significant after adjustment for multiple testing. Conclusions: We found a consistent pattern of better QOL outcomes at each follow-up assessment during the first 6 months of treatment for orchiectomized patients with metastatic prostate cancer who received placebo versus flutamide. Improvement over time was evident in both treatment groups but more so for patients receiving placebo. [J Natl Cancer Inst 1998;90:1537-44]

Management of complications of androgen deprivation therapy in the older man

“…Longitudinal studies of men on continuous ADT demonstrate a negative impact of therapy on QOL, especially on energy, sense of well-being, and physical functioning [85,156–162]. These studies are summarized in Table 4.…”

A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial

“…The role of oral antiandrogens on QoL was previously assessed by a randomized double‐blind SWOG trial in the context of advanced disease [7]. All patients had bilateral orchidectomy and were then randomized to flutamide or placebo.…”

“…The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36‐Item Short Form (SF‐36), University of California‐Los Angeles Sexual Function Scale (UCLA‐SFS), and Southwest Oncology Group Treatment‐Specific Symptoms Scale (SWOG‐TSSS) [7]. The SF‐36 was analysed using a composite score for each of physical health and mental health.…”

The Association of Retinoic Acid Receptor Beta2(RARβ2) Methylation Status and Prostate Cancer Risk: A Systematic Review and Meta-Analysis

“…Curative treatment entails radical prostatectomy or radiotherapy, and the best outcome is seen in patients with the earliest stage disease [2], [3]. Patients with locally advanced or systemic disease carry a poor long-term prognosis because of the notable lack of curative therapy [4].…”