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VOLUME 29 䡠 NUMBER 4 䡠 FEBRUARY 1 2011 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Comparison of Health-Related Quality of Life 5 Years After SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial Juanita Mary Crook, Alfonso Gomez-Iturriaga, Kris Wallace, Clement Ma, Sharon Fung, Shabbir Alibhai, Michael Jewett, and Neil Fleshner From the University of Toronto, University Health Network, and Princess Margaret Hospital, Toronto, Ontario, Canada. Submitted July 27, 2010; accepted October 25, 2010; published online ahead of print at www.jco.org on December 13, 2010. Presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, CA, and American Brachytherapy Society 2010 Annual Meeting, April 29-May 1, 2010, Atlanta, GA. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article. Corresponding author: Juanita Mary Crook, MD, FRCPC, British Columbia Cancer Agency, Center for the Southern Interior, 399 Royal Ave, Kelowna, BC, Canada, V1Y 5L3; e-mail: jcrook@ bccancer.bc.ca. © 2010 by American Society of Clinical Oncology 0732-183X/11/2904-362/$20.00 DOI: 10.1200/JCO.2010.31.7305 A B S T R A C T Purpose The American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial comparing radical prostatectomy (RP) and brachytherapy (BT) closed after 2 years due to poor accrual. We report health-related quality of life (HRQOL) at a mean of 5.3 years for 168 trial-eligible men who either chose or were randomly assigned to RP or BT following a multidisciplinary educational session. Patients and Methods After initial lack of accrual, a multidisciplinary educational session was introduced for eligible patients. In all, 263 men attended 47 sessions. Of those, 34 consented to random assignment, 62 chose RP, and 94 chose BT. Five years later, these 190 men underwent HRQOL evaluation by using the cancer-specific 50-item Expanded Prostate Cancer Index Composite, the Short Form 12 Physical Component Score, and Short Form 12 Mental Component Score. Response rate was 88.4%. The Wilcoxon rank sum test was used to compare summary scores between the two interventions. Results Of 168 survey responders, 60.7% had BT (9.5% randomly assigned) and 39.3% had RP (9.5% randomly assigned). Median age was 61.4 years for BT and 59.4 for RP (P ⫽ .05). Median follow-up was 5.2 years (range, 3.2 to 6.5 years). For BT versus RP, there was no difference in bowel or hormonal domains, but men treated with BT scored better in urinary (91.8 v 88.1; P ⫽ .02) and sexual (52.5 v 39.2; P ⫽ .001) domains, and in patient satisfaction (93.6 v 76.9; P ⬍ .001). Conclusion Although treatment allocation was random in only 19%, all patients received identical information in a multidisciplinary setting before selecting RP, BT, or random assignment. HRQOL evaluated 3.2 to 6.5 years after treatment showed an advantage for BT in urinary and sexual domains and in patient satisfaction. J Clin Oncol 29:362-368. © 2010 by American Society of Clinical Oncology INTRODUCTION Radical prostatectomy (RP) and permanent seed prostate brachytherapy (BT) are commonly offered as definitive management for favorable-risk prostate cancer (Gleason score ⱕ 6, prostate-specific antigen [PSA] ⬍ 10, stage T1 to T2a)1 and are generally considered to be equally effective.2-5 Since overall survival following either intervention is ⬎ 90% at 10 years,6,7 the effect of treatment on health-related quality of life (HRQOL) is important in decision making. Given the lack of good clinical comparative data, many patients make treatment decisions on the basis of anecdotal experience or unsubstantiated opinion. 362 Because no randomized clinical trials had successfully addressed relative efficacy or quality of life (QOL) following RP or BT,8-12 the American College of Surgeons Oncology Group (ACOSOG) undertook a phase III randomized trial to compare overall survival, treatment efficacy, and QOL for men with favorable-risk prostate cancer assigned to one of these two options. The Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial (SPIRIT; ACOSOG Z0070) received Cancer Therapy Evaluation Program (CTEP) approval in 2002 and subsequently opened in 31 centers across North America. Unfortunately SPIRIT closed prematurely in April 2004, having accrued only 56 of the intended 1,980 patients in 2 years. © 2010 by American Society of Clinical Oncology Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved. Quality of Life 5 Years After Prostatectomy or Brachytherapy To promote informed and unbiased patient decisions, trialeligible patients at the University Health Network (UHN) were invited to attend a multidisciplinary educational session before undergoing individual urology or radiation oncology consultations. Among the men attending these sessions, 190 underwent either BT or RP, either by choice or according to random assignment. These men are the subject of this QOL comparison in a single snapshot at a median of 5.2 years following treatment. Table 1. Summary Statistics by Intervention Domain Urinary Bowel Sexual Hormonal PATIENTS AND METHODS SPIRIT received approval of the Institutional Review Board at the UHN in May 2002 and was enthusiastically endorsed by the urologists and genitourinary radiation oncologists. Initially, eligible patients met with a research assistant (K.W.) and viewed the ACOSOG-developed educational video, but despite support of the consultants, no consents were obtained among the first 39 eligible patients. We then developed a small-group, multidisciplinary patient education session to provide the balanced information required for informed decision making.13 Weekly sessions for eligible new patients and their partners were held to compare RP and BT in a multidisciplinary setting, to establish the rationale for randomized trials in general, and to introduce SPIRIT. Following referral to the UHN, eligible patients were contacted by phone and invited to attend the 1.5-hour early evening session before their urology or radiation oncology consultations. In a small group setting, accompanied by their spouse, friend, or family member, they met with a research assistant, watched the ACOSOG informed consent video, and listened to a prostate cancer patient who explained to the group why he had chosen to participate in a clinical trial. Then a urologist and radiation oncologist joined the group and together compared and contrasted RP and BT, covering such topics as the requirement for anesthesia, length of hospital stay, impact on activities during recovery, nature of the PSA response, long-term urinary and sexual function, and options for salvage. Subsequently, over the next 7 to 10 days, the men would attend their individual specialty consultations. If either specialist felt that on the basis of prostate size, voiding function, comorbidities, or patient preference, an individual was more suited to one treatment or the other (or neither), the patient was informed of the recommendation and was not offered participation in the trial. Of the 268 men attending the sessions, 34 chose random assignment to SPIRIT, 94 chose BT, and 62 chose surgery, the remainder being directed toward external beam radiation therapy or surveillance. Treatment took place between September 2002 and July 2005. Treatment-related adverse effects generally stabilize within 3 years.14 Host hospital and university institutional review board approval was obtained to approach these 190 men for a QOL study at a median of 5.2 years (range, 3.2 to 6.5 years). An initial phone call verified their contact information, explained the reason for evaluating their QOL at this time, and assessed possible participation. If interest was expressed, the questionnaires were subsequently mailed out. Six men were lost to follow-up and 16 either declined or did not return the questionnaires, leaving 168 participants (response rate, 88.5%). The HRQOL instruments chosen for this evaluation were the prostate cancer–specific 50-item Expanded Prostate Cancer Index Composite (EPIC),15 Short Form 12 Physical Component Score (SF-12 PCS), Short Form 12 Mental Component Score (SF-12 MCS),16 and items regarding comorbidities and use of medications or devices to supplement erections. Both the EPIC and SF-12 instruments have excellent reliability and validity. Function and bother subscales elucidate how symptoms relate to impairment in each domain. Analysis The four primary end points of clinical interest designated for planned comparisons between the two interventions were the summary scores from the four prostate cancer–specific EPIC domains: urinary incontinence, urinary irritation/obstruction, sexual function, and bowel function. For each domain, higher total scores imply a better HRQOL, with the majority of questions using www.jco.org Patient satisfaction SF-12 PCS SF-12 MCS Intervention Mean SD P BT RP BT RP BT RP BT RP BT RP BT RP BT RP 91.82 88.15 93.0 94.37 52.54 39.22 93.52 89.98 93.63 76.89 55.88 55.42 44.72 43.19 8.53 11.47 11.62 8.91 24.06 25.35 8.27 12.79 12.03 27.49 9.69 8.85 5.28 5.81 .02 .34 .001 .1 ⬍ .001 .38 .04 Abbreviations: SD, standard deviation; BT, brachytherapy; RP, radical prostatectomy; SF-12 PCS, Short Form 12 Physical Component Score; SF-12 MCS, Short Form 12 Mental Component Score. Likert-type or similar ordinal response scales (eg, no, very small, small, moderate, big problem). Four primary comparisons were performed between the intervention arms, with one comparison for each of the four primary EPIC HRQOL domain measures by using a Wilcoxon rank sum test with consideration of the Bonferroni correction for multiple testing.17 The nonparametric Mann-Whitney test was used to compare the summary scores of the two interventions. The estimated difference between the two intervention arms with the standard deviations (SDs) is presented for each of the four EPIC domains (Table 1). The response distribution for representative EPIC items (including domain-specific University of California, Los Angeles-Prostate Cancer Index bother items) are tabulated and summarized via stacked bar charts (Figs 1 and 2). When comparing baseline characteristics and comorbidities, continuous variables were compared by using analysis of variance (ANOVA) and categoric variables using Fisher’s exact test. SAS version 9.1 (SAS Institute, Cary, NC) and R version 2.7 (www.r-project.org) statistical software was used for the analysis. RESULTS Sixty-six men were treated by RP (16 randomly assigned; 50 choice) and 102 received BT (16 randomly assigned; 86 choice). The median time from treatment to the QOL assessment was 5.2 years (range, 3.2 to 6.5 years). Median age of the entire cohort was 60 years (range, 45 to 73 years) with patients in the BT cohort being an average of 2 years older than patients in the RP cohort (median age for BT, 61.4 years; for RP, 59.4 years; P ⫽ .05). None of the comorbidities assessed, including diabetes, heart disease, and hypertension, showed a difference between the two intervention cohorts (Table 2). Only 7.1% were current smokers while 52.4% were former smokers, and 39.5% were lifetime nonsmokers. A college education or higher was reported in 81.6%. Mean baseline PSA was similar (5.5 ng/mL for BT and 5.3 ng/mL for RP; P ⫽ .38), although mean baseline International Prostate Symptom Score (IPSS) was lower in the BT cohort (5.8 v 8.6; P ⫽ .02). The results of comparison of the four cancer-specific EPIC domains are provided in Table 1. There was no difference between the two groups in the bowel or hormonal domains or in the SF-12 PCS. There was a borderline difference in the SF-12 MCS (P ⫽ .04), a statistically significant difference in the urinary domain (P ⫽ .02), © 2010 by American Society of Clinical Oncology Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved. 363 Crook et al More than once a day About once a day More than once a week About once a week Rarely or never P < .0001 90 70 60 50 40 Percentage 50 40 20 10 10 100 0 RP More than once a day About once a day More than once a week About once a week Rarely or never P = .18 80 70 60 50 40 B 60 50 40 20 10 0 RP No problem Very small problem Small problem Moderate problem Big problem P = .83 80 70 60 50 40 C Very poor Poor Fair Good Very good P = .003 80 70 60 50 40 30 20 10 10 RP RP 90 20 BT BT 100 30 0 Not firm enough for any sexual activity Firm enough for masturbation and foreplay only Enough for intercourse 70 10 90 None at all P = .002 80 30 100 RP 90 20 BT BT 100 30 0 Percentage 60 30 90 C 70 20 BT Very poor to none Poor Fair Good Very good P = .007 80 30 0 B 100 90 Percentage Percentage 80 A Percentage 100 Percentage A 0 BT RP Fig 1. Stacked bar charts on three selected questions from the Expanded Prostate Cancer Index Composite urinary domain illustrating patient responses for the two interventions concerning (A) urinary leakage, (B) pain and burning with urination, and (C) weak stream or incomplete emptying. BT, brachytherapy; RP, radical prostatectomy. Fig 2. Stacked bar charts on three selected questions from the Expanded Prostate Cancer Index Composite sexual domain illustrating patient responses for the two interventions concerning (A) the ability to have an erection, (B) the quality of erections, and (C) the ability to function sexually. BT, brachytherapy; RP, radical prostatectomy. and highly significant differences in the sexual domain (P ⫽ .001) and patient satisfaction score (P ⬍ .001), all favoring BT. Individual questions were examined within the urinary domain (Fig 1) to ascertain which symptoms predominated at 5 years. Questions regarding how often urine leakage occurred, urinary control, and the degree of problem with dripping or leaking urine all showed a P value ⬍ .001 in favor of BT, whereas none of the questions on irritative and obstructive symptoms, which might persist in a BT population, showed a difference. In the sexual domain, many of the questions showed a highly significant difference in favor of BT, including questions on the ability to have an erection (P ⬍ .001), the quality of erections (P ⬍ .001), the frequency of erections (P ⫽ .003), awakening with an erection (P ⫽ .002), and the ability to function sexually (P ⫽ .003; Fig 2). The associated degree of the problem with these changes, as evaluated by the “bother” scores of EPIC, also reached significance but at levels of P ⫽ .02 to P ⫽ .049. The median current PSA for the RP cohort is ⬍ 0.05 ng/mL (mean, 0.03 ng/mL; SD, 0.19) and for the BT cohort, it is 0.05 ng/mL (mean, 0.15 ng/mL; SD, 0.36) Readings reported as ⬍ 0.05 ng/mL were treated as zero. 364 © 2010 by American Society of Clinical Oncology JOURNAL OF CLINICAL ONCOLOGY Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved. Quality of Life 5 Years After Prostatectomy or Brachytherapy valid summary scores. Whether evaluated as small, singleinstitution studies19,25 or as population-based assessments, it is expected that HRQOL will have stabilized 2 to 3 years after RP.14,21 Physician-reported data suggest that men undergoing prostate BT are also prone to urinary, bowel, and sexual adverse effects. Urinary symptoms are largely irritative and obstructive (ie, frequency, nocturia, and dysuria) and are at their worst in the first 2 to 6 months, improving by 12 months.26-28 However, as is the case after RP, physician-reported morbidity may underestimate adverse HRQOL effects when compared with patient-reported data. Table 2. Baseline Characteristics Characteristic Age, years Median SD IPSS Median SD PSA, ng/mL Median SD Potency Medications for DM, HT, or CVD Brachytherapy Prostatectomy No. No. % % P .05 61.4 6.2 59.4 5.9 5.8 4.7 8.6 7.0 5.5 2.1 5.3 2.8 .02 .38 87.1 94.8 .17 50 40.9 .27 Abbreviations: SD, standard deviation; IPSS: International Prostate Symptom Score; PSA, prostate-specific antigen; DM, diabetes mellitus; HT, hypertension; CVD, cardiovascular disease. All BT procedures were performed by one experienced individual (J.M.C.). However, patients referred from a community urologist who declined the trial and chose surgery returned to their referring urologist. Thus, 30% of the prostatectomies were performed in the community rather than at the UHN. Table 3 provides the summary results for each domain compared between randomly assigned patients in SPIRIT and those who followed their preference (choice), and Table 4 for UHN surgeons compared with community surgeons. DISCUSSION Urinary incontinence and erectile dysfunction are recognized as common sequelae of RP12,18,19 and have been evaluated in many single-institution studies by using physician-reported data. However, adverse urinary and sexual HRQOL effects are more prevalent when using patient-reported data.20-24 Prospective assessment of postprostatectomy HRQOL using validated HRQOL instruments allows the outcomes to be expressed in psychometrically robust, Instruments for Evaluating HRQOL after RP or BT Prostate intervention–related symptoms can be measured by various instruments that include subscales to measure urinary, bowel, and sexual function. One such instrument, the 20-item University of California, Los Angeles-Prostate Cancer Index, was revised following input from patients and physicians15 to create the 50-item EPIC. EPIC was validated in a cohort comprising controls and patients with prostate cancer who had undergone RP, BT, or external beam radiation.11 The advantages of EPIC include the presence of multi-item bother scales for each HRQOL domain, the addition of irritative urinary symptoms and bother assessment, and improved bowel domain characteristics to evaluate hematochezia, the most common bowel toxicity after irradiation. Treatment-related changes can thus be separated into five discrete domains: urinary incontinence, urinary irritation/ obstruction, and sexual, bowel, and hormonal functions. Changes in these intrinsic visceral functions may dramatically alter QOL, indirectly affecting psychosocial function and emotional distress, as measured by the SF-12 PCS or SF-12 MCS scores. The combination of EPIC and the two SF-12 forms provides a valid measure of HRQOL related to prostate cancer therapy. Urinary and bowel domains do not show marked differences related to interval of follow-up from 2 years to 4 years after intervention, regardless of whether a patient undergoes RP or BT. Assessment during this steady-state allows the long-term, stable effects of RP and BT on HRQOL function to be described before possible HRQOL effects from cancer recurrence or progression might occur that could complicate data analysis. Such an analysis was planned in the QOL companion study to SPIRIT—ACOSOG Z0071. Table 3. Summary Statistics by Intervention to Compare Patients Randomly Assigned to SPIRIT With Patients Who Had a Choice Within Each Intervention Domain Urinary Sexual Patient satisfaction Intervention No. of Patients Mean SD P BT SPIRIT BT choice RP SPIRIT RP choice BT SPIRIT BT choice RP SPIRIT RP choice BT SPIRIT BT choice RP SPIRIT RP choice 15 86 15 52 15 84 15 52 15 86 15 52 93.37 91.54 82.87 89.83 61.1 50.91 38.54 39.43 98.44 92.73 79.69 76.0 3.36 9.16 12.05 10.86 25.72 23.55 28.86 24.44 6.25 12.64 29.18 27.18 .82 .02ⴱ .09 .86 .08 .43 Abbreviations: SPIRIT, Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial; SD, standard deviation; BT, brachytherapy; RP, radical prostatectomy. ⴱ Not significant after Bonferroni correction. www.jco.org © 2010 by American Society of Clinical Oncology Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved. 365 Crook et al Table 4. Summary Statistics to Compare UHN Surgery With Community Surgery Within Each Domain Domain Urinary Sexual Patient satisfaction Surgery Site No. of Patients Mean SD P UHN Community UHN Community UHN Community 47 20 47 20 47 20 87.98 88.52 39.32 38.97 79.89 70.0 10.38 13.95 26.74 22.47 27.7 26.41 .45 1.0 .06 Abbreviations: UHN, University Health Network; SD, standard deviation. The experience with SPIRIT illustrates the difficulty in undertaking a comparison of established competing treatments in a randomized trial. Even when the involved specialists can achieve and maintain a neutral stance, the North American patient-consumer can be quite partisan. In contrast, Giberti et al29 recently published a randomized comparison of RP and BT in which 200 men were randomly assigned in a single Italian center over a 3.5-year period. The article does not discuss methods of recruitment or difficulties encountered in obtaining informed consent. SPIRIT has demonstrated that such an achievement is not possible in North America. Our multidisciplinary patient education session was strikingly successful compared with experience in other centers, resulting in 34 of the 52 consents to SPIRIT obtained across North America in a 2-year period. Even so, our recruitment rate was only 1 in 6. Given the experience with SPIRIT and the expense involved in undertaking a large-scale, multicenter randomized trial, it is unlikely that this question will be readdressed in a randomized study in North America. This does not, however, preclude prospective collection of HRQOL data in a nonrandomized setting such as a registration trial conducted in a manner similar to this study. If all men are equally well informed about both treatment options and considered equally appropriate for either, then the HRQOL comparison should be valid. In the present report, 19% of the participants were randomly assigned and although the numbers are small, their results were consistent with the overall results (Table 3). Patients are willing to accept self-limited acute adverse effects associated with recovery. These have been well documented for both modalities and are quite different. Late effects have been less well documented and, at the time of this study, never compared in a randomized trial. Since PSA screening has reduced the age at diagnosis of prostate cancer by a decade, long-term QOL considerations are even more important in treatment choice. The need for reliable data is paramount. It has been well established that physician-reported QOL and adverse effects frequently underestimate their frequency, severity, and importance. This study has the advantage of not only being patient-reported but also of patient anonymity; the questionnaires were not administered or discussed with the patients by any of the treating physicians. Some limitations of this study need to be acknowledged. All the BT procedures were performed by one experienced operator who has published extensively on prostate BT, quality assurance, and predictors of morbidity.28,30-32 The degree of satisfaction with BT expressed by the study cohort may not translate directly to the wider practice of BT. In contrast to the BT cohort, 30% of men undergoing RP returned to their community urologist for surgery. 366 © 2010 by American Society of Clinical Oncology In addition, there were slightly more nonresponders from the RP cohort (16%) compared with the BT cohort (8.5%). Finally, since the same HRQOL instruments were not used at baseline, a change from baseline could not be evaluated for the individual patient. Although there was no difference in the reported distribution of medical comorbidities, age may affect the sexual and urinary effects of prostate cancer treatment.33 Nonetheless, the BT cohort still fared better in the urinary and sexual domain despite being 2 years older than the RP cohort. Baseline urinary and sexual function may have influenced patients’ choices of treatment modality; the RP cohort did have a higher IPSS at baseline, but prior potency was reported at a similar frequency in both cohorts. A recently published randomized trial by Giberti et al29 involved a similar patient cohort with favorable-risk prostate cancer and similar exclusion criteria, although men in the Giberti trial were an average of 5 years older. All surgical patients had bilateral nerve-sparing surgery performed by the same surgeon. At the 5-year follow-up (available for 87%), Giberti et al reported no significant differences in urinary or sexual function between BT and RP. Mild postoperative incontinence was seen in 13% of the patients who recovered spontaneously, while those with severe incontinence had corrective surgery. Good erectile function at 5 years was reported in 65% of RP and 68% of BT patients (78% at 1 year). In contrast, in this study, a statistically significant difference in favor of BT was found in the both the urinary and sexual domains. Although specific questions relating to incontinence showed a highly significant difference (P ⬍ .001), overall the mean scores in the urinary domain were separated by only a 3.7-point difference (P ⫽ .02), which is equivalent to a small effect size34 and may have questionable clinical significance (Appendix, online only). Although bilateral nerve sparing was the surgical standard for RP at the UHN, men operated on in the community fared equally well in the sexual domain (Table 4). Overall, erections firm enough for sexual activity were reported by 79% of men treated with BT compared with 48% of those treated by RP (P ⬍ .001), and 66% of men after BT had erections at least half the time when they wanted as compared with 40% after surgery (P ⫽ .003). In terms of erectile aids, no patients had penile prostheses, 63% were using phosphodiesterase 5 (PDE-5) with the addition of penile injections in 5%, 2% were using Muse, and 2% a vacuum device. There was no difference in the use of PDE-5 between the two interventions, but more men in the RP group used injections, Muse, or a vacuum device (7 v 1). Giberti et al29 do not mention PDE-5 use, the encouragement of which in our BT population may have prevented a late decline in erectile function. JOURNAL OF CLINICAL ONCOLOGY Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved. Quality of Life 5 Years After Prostatectomy or Brachytherapy Clearly there is a need for long-term comparative outcomes for QOL after definitive treatment for early-stage favorable-risk prostate cancer. Although an active surveillance approach is becoming more widespread,35 especially for older men, many younger men and their physicians are more comfortable with definitive treatment, especially given the lack of ability to monitor progression of disease with certainty. To make an informed choice on treatment versus surveillance, and specifically which type of treatment, an accurate representation of the tradeoffs is necessary. It should be recalled that this report is essentially a single-center study, with all BT performed by a single operator and the majority of the surgery done by two experienced university urologists. It was not our intent, when these men in the study cohorts first presented, to enter into this type of HRQOL comparison. A prospective multicenter registration study with a larger number of patients for comparing these modalities, such as that recently published by Sanda et al36 assessing the evolution of early toxicity, will undoubtedly yield worthwhile data with longer follow-up. In conclusion, the 168 men in this QOL cohort were fully informed about their treatment options and were felt to be equally appropriate for either RP or BT. Five years after treatment with one of these two options, either by choice or by random assignment, a QOL REFERENCES 1. D’Amico AV, Vogelzang NJ: Prostate brachytherapy: Increasing demand for the procedure despite the lack of standardized quality assurance and long term outcome data. Cancer 86:1632-1634, 1999 2. Potters L, Morgenstern C, Calugaru E, et al: 12-year outcomes following permanent prostate brachytherapy in patients with clinically localized prostate cancer. J Urol 173:1562-1566, 2005 3. 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