Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: The Scandinavian Prostate Cancer Group-4 randomised trial

Department of Surgical Sciences, University Hospital of Uppsala, Uppsala, Sweden.
The Lancet Oncology (Impact Factor: 24.69). 08/2011; 12(9):891-9. DOI: 10.1016/S1470-2045(11)70162-0
Source: PubMed

ABSTRACT For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years.
All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint.
182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life.
For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information.
US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

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    • "We modified the clinometric questionnaire previously used in a randomized trial evaluating the effects of radical prostatectomy, SPCG-4, to collect information on possible confounding factors, mediating factors, and effect-modifying factors [31] [32]. Most questions have been used in one or several of the 25 data collections previously carried out at the Division of Clinical Cancer Epidemiology [33] [34] [35]. Nevertheless, to make sure the questions and answer categories were understood correctly by men with a recent diagnosis of prostate cancer, the questionnaires underwent face-to-face validation. "
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    ABSTRACT: Many elderly or impotent men with prostate cancer may not receive a bundle-preserving radical prostatectomy as a result of uncertainty regarding the effect on urinary incontinence. We searched for predictors of urinary incontinence 1 yr after surgery among surgical steps during radical prostatectomy. More than 100 surgeons in 14 centers prospectively collected data on surgical steps during an open or robot-assisted laparoscopic radical prostatectomy. At 1 yr after surgery, a neutral third-party secretariat collected patient-reported information on urinary incontinence. After excluding men with preoperative urinary incontinence or postoperative irradiation, data were available for 3379 men. Surgical steps during radical prostatectomy, including dissection plane as a measure of the degree of preservation of the two neurovascular bundles. Urinary incontinence 1 yr after surgery was measured as patient-reported use of pads. In different categories of surgical steps, we calculated the percentage of men changing pads "about once per 24 h" or more often. Relative risks were calculated as percentage ratios between categories. A strong association was found between the degree of bundle preservation and urinary incontinence 1 yr after surgery. We set the highest degree of bundle preservation (bilateral intrafascial dissection) as the reference category (relative risk = 1.0). For the men in the remaining six groups, ordered according to the degree of preservation, we obtained the following relative risks (95% confidence interval [CI]): 1.07 (0.63-1.83), 1.19 (0.77-1.85), 1.56 (0.99-2.45), 1.78 (1.13-2.81), 2.27 (1.45-3.53), and 2.37 (1.52-3.69). In the latter group, no preservation of any of the bundles was performed. The pattern was similar for preoperatively impotent men and for elderly men. Limitations of this analysis include the fact that noise influences the relative risks, due to variations between surgeons in the use of undocumented surgical steps of the procedure, variations in surgical experience and in how the surgical steps are reported, as well as variations in the metrics of patient-reported use of pads. We found that the degree of preservation of the two neurovascular bundles during radical prostatectomy predicts the rate of urinary incontinence 1 yr after the operation. According to our findings, preservation of both neurovascular bundles to avoid urinary incontinence is also meaningful for elderly and impotent men. We studied the degree of preservation of the two neurovascular bundles during radical prostatectomy and found that the risk of incontinence decreases if the surgeon preserves two bundles instead of one, and if the surgeon preserves some part of a bundle rather than not doing so. Copyright © 2014. Published by Elsevier B.V.
    European Urology 10/2014; 67(3). DOI:10.1016/j.eururo.2014.10.011 · 13.94 Impact Factor
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    • "A prostate biopsy is not without adverse effects; 0.7% of men biopsied were hospitalized as a result of sepsis and/or hemorrhage [27] and thus avoiding biopsies is a worthwhile aim, if the number of clinically significant cancers detected is not prejudiced. Treatment of prostate cancer is similarly not without its adverse effects, including sexual function, urinary incontinence, and bowel problems [28, 29]. Therefore, as men with low risk or indolent prostate cancer are five times more likely to die from other diseases and the 12-year survival in this group is not improved by local therapy [30], a screening test must differentiate between these patients and those with clinical significant prostate cancer which needs treatment. "
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    ABSTRACT: Introduction: PSA parameters have been used in an attempt to improve the diagnostic yield of prostate screening tests; the detection of primary malignant circulating prostate cells (CPCs) may improve the diagnostic yield of screening and therefore avoid unnecessary biopsies. Patients and methods: Prospective study of all men undergoing initial prostate biopsy due to an elevated total serum PSA. Free percent PSA, PSA velocity, and PSA density were determined. Primary CPCs were detected using standard immunocytochemistry. A positive test for CPCs was defined as one cell PSA (+) P504S (+) in an 8 ml blood sample. Positive predictive and negative predictive values, specificity, and sensitivity were calculated for each test as well as the number of biopsies avoided and cancers missed. Results: 303 men participated in the study of whom 113/303 (37.3%) men had prostate cancer. Of the three PSA based parameters, free percent PSA was superior, sensitivity 70.8%, and specificity 67.4%. Primary CPCs detection had a sensitivity of 88.5% and a specificity of 88.4% avoiding 181 (59.7%) biopsies, detecting 93/95 (98%) of clinically significant cancers, and missing 13 (11.5%) low grade, small volume tumors. Conclusions: The use of primary CPCs as a sequential test could decrease the number of initial prostate biopsies missing those cancers which are treated by active observation.
    BioMed Research International 07/2014; 2014:676572. DOI:10.1155/2014/676572 · 2.71 Impact Factor
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    • "Prostate cancer itself may impair the integrity of the anatomic structures that maintain urinary continence. When compared to their peers without prostate cancer, even men who choose active surveillance are at increased risk of UI [37,45,46]. Previous studies of alternative radiation modalities have also reported that late toxicity following radiation therapy is associated with pretreatment factors related to BPH, such as a high AUA score [47,48] and a large prostate volume [49]. "
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    ABSTRACT: Purpose Urinary incontinence (UI) following prostate radiotherapy is a rare toxicity that adversely affects a patient’s quality of life. This study sought to evaluate the incidence of UI following stereotactic body radiation therapy (SBRT) for prostate cancer. Methods Between February, 2008 and October, 2010, 204 men with clinically localized prostate cancer were treated definitively with SBRT at Georgetown University Hospital. Patients were treated to 35–36.25 Gray (Gy) in 5 fractions delivered with the CyberKnife (Accuray). UI was assessed via the Expanded Prostate Index Composite (EPIC)-26. Results Baseline UI was common with 4.4%, 1.0% and 3.4% of patients reporting leaking > 1 time per day, frequent dribbling and pad usage, respectively. Three year post treatment, 5.7%, 6.4% and 10.8% of patients reported UI based on leaking > 1 time per day, frequent dribbling and pad usage, respectively. Average EPIC UI summary scores showed an acute transient decline at one month post-SBRT then a second a gradual decline over the next three years. The proportion of men feeling that their UI was a moderate to big problem increased from 1% at baseline to 6.4% at three years post-SBRT. Conclusions Prostate SBRT was well tolerated with UI rates comparable to conventionally fractionated radiotherapy and brachytherapy. More than 90% of men who were pad-free prior to treatment remained pad-free three years following treatment. Less than 10% of men felt post-treatment UI was a moderate to big problem at any time point following treatment. Longer term follow-up is needed to confirm late effects.
    Radiation Oncology 06/2014; 9(1):148. DOI:10.1186/1748-717X-9-148 · 2.55 Impact Factor
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