Two recent JAMA studies confirm a higher rate of sexual and urinary side effects with radical prostatectomy compared with radiation therapy and surveillance.
Two new large studies appearing in the JAMA document quality-of-life outcomes associated with various approaches to the management of localized prostate cancer. The studies confirm a higher rate of sexual and urinary side effects with radical prostatectomy (RP) compared with radiation therapy and surveillance.
The knowledge gained from these studies is critical for shared decision-making, as quality-of-life issues often guide management decisions in men with low-risk prostate cancer, the authors maintain.
In the first study, investigators led by Daniel Barocas, MD, MPH, examined functional outcomes and adverse effects of 2,250 men 80 years of age and younger who were diagnosed in 2011-2012 with clinical stage cT1-2 localized prostate cancer (JAMA 2017; 317:1126-40). All men had a PSA <50 ng/mL. They were identified from five Surveillance, Epidemiology, and End Results registries in Atlanta, Los Angeles, Louisiana, New Jersey, and Utah, and the Cancer of the Prostate Strategic Urologic Research Endeavor registry. The study included follow-up through August 2015.
Of the 2,550 men, 1,523 underwent RP, 598 were treated with external beam radiation (EBRT), and 429 were managed with active surveillance. About three-fourths of the cohort was Caucasian. The primary outcome measures were the domain scores on the 26-item Expanded Prostate Cancer Index Composite, which ranges from 0 to 100 (higher scores indicate better function), at 3 years.
After adjustment for baseline domain scores and other covariates, the decline in sexual domain scores was 11.9 points greater in the RP group compared with the cohort that underwent EBRT and 16.2 points greater than those who were managed by active surveillance. The decline in sexual domain scores was not significantly different between the EBRT and active surveillance groups at 3 years.
“Erectile dysfunction 3 years after treatment was more common in men treated with surgery than radiation. But this difference was only evident in the 25% of men with excellent function before treatment,” said Dr. Barocas, of Vanderbilt University, Nashville, TN. “Men with erectile dysfunction before treatment have ‘less to lose’ and end up having low function regardless of which treatment they choose.”
Urinary incontinence was worse after RP compared with baseline, whereas men in the other two groups did not have a significant change in urinary incontinence score from baseline. At 3 years, adjusted mean incontinence scores were 12.7 points worse for RP compared with active surveillance and 18.0 points worse compared with EBRT. Both of these differences were considered clinically meaningful; the minimal clinically important difference was defined as at least 6 points. Urinary incontinence was reported as a moderate or big problem in 14% of men 3 years after RP compared with 5% who had EBRT.
Urinary irritative scores improved in men undergoing RP and changed little or were unchanged in men in the EBRT and active surveillance groups. There were no significant differences between groups in bowel or hormonal function beyond 12 months, and no meaningful differences in health-related quality of life, the authors found.
Three-year prostate cancer-specific survival was excellent in all three groups at >99%.
The second study involved 1,141 men with early-stage prostate cancer who were identified from the North Carolina Central Cancer Registry between January 2011 and June 2013 (JAMA 2017; 317:1141-50). The median time from diagnosis to enrollment in the study was 5 weeks.
Quality of life was assessed using the Prostate Cancer Symptom Indices (PCSI), with surveys completed by telephone at baseline (pretreatment), and 3, 12, and 24 months after the treatment date. The PCSI has four domains: urinary obstruction and irritation (five items), urinary incontinence (three items), sexual dysfunction (five items), and bowel problems (six items), with each domain scored on a 0 to 100 scale (higher scores indicate more/worse dysfunction. For men choosing active surveillance, an anchor date was assigned as 3 months after diagnosis to calculate subsequent survey dates.
Of the 1,141 men enrolled, 314 (27.5%) pursued active surveillance, 249 (21.8%) EBRT, 109 (9.6%) brachytherapy, and 469 (41.1%) chose RP. Almost all RP procedures were performed robotically, and almost all patients who chose EBRT received intensity-modulated radiation. The median age was 66 to 67 years across groups, and 77% to 80% were Caucasian.
Compared with active surveillance, at 3 months:
At 2 years, more than 57% of men who had normal sexual function prior to treatment reported poor sexual function after surgery, compared with 27% who reported poor sexual function after EBRT, 34% after brachytherapy, and 25% after active surveillance.
“With modern robotic surgery, sexual dysfunction and urinary incontinence continue to be some of the side effects that surgery can cause,” said lead investigator Ronald Chen, MD, MPH, of the University of North Carolina, Chapel Hill, in a prepared statement. “While we do see improvement over time, even at the 2-year point, surgery still causes more of these issues than other treatments.”
By 24 months, scores on most domains were similar between patients who chose EBRT or brachytherapy and those who chose active surveillance.
“Prostate cancer treatment technologies have improved significantly over time,” Dr. Chen indicated in an email exchange with Urology Times. “Patients today must have up-to-date information about the quality of life impact of treatment options they have now, and this study provides that information which urologists can use to counsel their patients.”
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