Prostate Cancer and Prostatic Diseases (2004) 7, 144–151 & 2004 Nature Publishing Group All rights reserved 1365-7852/04 $30.00 www.nature.com/pcan A 3-y prospective study of health- related and disease-specific quality of life in patients with nonmetastatic prostate cancer treated with radical prostatectomy or external beam radiotherapy

K Yoshimura1, Y Arai2*, K Ichioka1, Y Matsui1, K Ogura3 & A Terai1 1Department of Urology, Kurashiki Central Hospital, Sendai, Japan; 2Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan; and 3Department of Urology, Otsu Red Cross Hospital, Sendai, Japan

We assessed the longitudinal alteration of the quality of life (QOL) of patients with localized prostate cancer after radical prostatectomy or hormonoradiotherapy during 3-y follow-up. In addition, we examined the impact on QOL of initiation of second treatment after failure of primary treatment. In all, 135 patients with localized prostate cancer who underwent radical retropubic prostatectomy (RP) (N ¼ 84) or external beam radiotherapy with neoadjuvant hormone (XRT) (N ¼ 51) at our institute and who had a minimum follow-up of 3 y were included in this study. Data were collected prospectively, at baseline, at 3 months after treatment, at 1 y, and annually thereafter. QOL, generic and disease-targeted was evaluated using the European Organization for Research and Treatment of Cancer Prostate Cancer QOL Questionnaire, the Sapporo Medical University Sexual Function Questionnaire, the International Prostate Symptom Index Quality of Life Score and similar questions regarding bowel function. Repeated-measures ANOVA revealed significantly different patterns of alteration in the domains of QOL, with the exception of several domains, between the RP and XRT groups. Rapid decline of sexual function and increase in sexual bothersomeness were followed by slight amelioration throughout follow-up in the RP group, and did not change thereafter in the XRT group. Overall satisfaction with urinary condition significantly improved after treatment and that with bowel condition was stable during follow- up in both of the groups. Failure of primary treatment and initiation of salvage treatment had no impact on QOL. This prospective study revealed longitudinal alteration of QOL status of patients undergoing treatment for localized prostate cancer, but did not yield any conclusions regarding effect of treatment failure and second treatment on QOL due to small sample size. It should be noted that different instruments for assessment of QOL can generate different outcomes. Prostate Cancer and Prostatic Diseases (2004) 7, 144–151. doi:10.1038/sj.pcan.4500714 Published online 27 April 2004

Keywords: quality of life; prospective study; radical retropubic prostatectomy; external beam radiation therapy

Introduction *Correspondence: Y Arai, Department of Urology, Tohoku University In recent years, screening for prostate cancer has Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan. E-mail: [email protected] promoted detection of disease at an earlier stage. Since Received 12 January 2004; revised 10 February 2004; accepted 25 locally confined prostate carcinoma rarely exhibits rapid February 2004; published online 27 April 2004 progression, it is likely that patients with localized Quality of life in patients with prostate cancer K Yoshimura et al prostate cancer can live long lives. Thus, health-related the patient was older than 75 y and/or had a tumor with 145 quality-of-life effects may play a crucial role in determin- clinical stage of cT3a or higher. However, final determi- ing choice of treatment. nation of treatment modality was made by the patient The standard treatment options for localized prostate after thorough discussion of options including watchful cancer in Japan include radical prostatectomy and waiting. external-beam radiation. It is known that prostatectomy Of 84 patients in the RP group, 10 received neoadju- can induce urinary incontinence and erectile dysfunction vant hormone therapy 3–6 months prior to RP. Of 10 due to damage to the urinary sphincter and cavernous patients receiving preoperative hormone therapy, seven nerve.1,2 Irradiation therapy is associated with bladder had clinical T3 disease. One of the remaining three irritability, rectal irritability, and erectile dysfunction.3 patients had clinical T2 and the other two had clinical While these treatment options directly influence quality T1c disease with high serum PSA level of 31–97 ng/ml. of life (QOL), especially several disease-specific domains Although usefulness of neoadjuvant hormone therapy is including urinary, bowel, and sexual conditions, long- questionable at present, it was considered a permissible term follow-up may reveal impacts of other factors such option for locally advanced prostate cancer during this as salvage therapy for initial treatment failure and entry period. The procedure of RP was essentially the initiation of second treatment. same as that originally described by Walsh. The Many studies published in the past decade examined cavernous nerve was spared bilaterally in 26 patients, the QOL of patients with localized prostate cancer, and and unilaterally in 39. Pelvic lymph node dissection was we also previously reported short-term changes of QOL routinely performed. Three of us (YA,KY,KO) performed of patients undergoing radical prostatectomy.4 However, all operations. Of 51 patients in the XRT group, all most of these studies were retrospective, cross-sectional, received neoadjuvant hormone therapy using leuprolide or short-term prospective ones. Further, most of the or goserelin. Median duration from hormone therapy to studies reported previously used the Medical Outcome radiation was 6.7 months. All of these patients under- Study Short Form-36 (SF-36)5 and the University of went external beam radiation to a total of 66 Gy with the California at Los Angeles Prostate Cancer Quality of Life conventional method. Index (UCLA PCI)6 as modalities for evaluation of QOL. Our definition of PSA failure was as follows: (1) in the These questionnaires are well-constructed and utilized RP group, PSA nadir above 0.1 ng/ml, or three con- widely throughout the world. However, there is no secutive PSA increases from nadir below 0.1 ng/ml, (2) in single perfect questionnaire and each validated ques- the XRT group, three consecutive PSA increases after 1- tionnaire has different characteristics. year from termination of radiation therapy. In this long-term prospective study with a minimum follow-up of 3 y, we attempted despite the small size of the study population to examine the following two QOL methodology issues: first, longitudinal alteration of QOL after treat- ment, and second, the impact of initiation of second The primary health-related QOL measure used was the treatment on QOL after failure of primary treatment. Japanese version of the European Organization for Since we conducted this study using the European Research and Treatment of Cancer Prostate Cancer Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC-P), which was Prostate Cancer QOL Questionnaire (EORTC-P)7 and validated by Isaka et al.9 The questionnaire consists of the Sapporo Medical University Sexual Function Ques- 32 items grouped into the following scales: physical tionnaire (SMUSFQ),8 our study may yield findings other functioning (PF, eight items); physical symptoms (PS, than studies performed with the SF-36 and UCLA PCI. nine items); fatigue/malaise (FM, five items); sexual problems (SP, three items); psychological distress (PD, five items); and impact of the disease on family/social life (ID, two items). Subscale scores were the sum of the Materials and methods items in each domain. In addition to the 32-item scale, the Face Scale, prepared with some modification from Between April 1996 and October 2000, a total of 167 men the original form reported by Lorish and Maisiak,10 with localized prostate cancer received treatment with contains five drawings of a single face arranged in radical retropubic prostatectomy (RP) or external radia- decreasing order of mood and numbered from 1 to 5, tion therapy (XRT) at our institute. After informed with 1 representing the most positive mood and 5 consent, 135 patients (81%) participated in this study. representing the most negative mood. Of the 135 patients, 84 underwent RP and 51 underwent Disease-targeted measures were used to address the XRT. The questionnaires mentioned below were an- level of function or amount of bothersomeness of sexual, swered by the participants before treatment, 3 months urinary, and bowel functions. To evaluate sexual func- and 1 y after treatment, and annually thereafter. They tion, we used the questionnaire developed by researchers were staged with digital rectal examination, transrectal at the Sapporo Medical University School of Medicine ultrasound (TRUS), abdominal computed tomography, (SMUSM), which has been validated in more than 5000 and bone scan, according to the 1992 UICC staging adult Japanese men.8 It concerns sexual desire, ability to system. All patients underwent prostate-specific antigen have an erection, and quality of sexual activity, as we (PSA) determination before prostate biopsy. previously described. To evaluate amount of compre- Basically, we recommended retropubic radical prosta- hensive bothersomeness of urinary function, we used the tectomy if the patient was 75 y of age or younger and had International Prostate Symptom Score quality of life (I- a tumor with a clinical stage of cT2c or lower, and PSS QOL) score.11 We also used other questions related to recommended XRT with neoadjuvant hormone therapy if stress incontinence and number of pads use (Appendix

Prostate Cancer and Prostatic Diseases Quality of life in patients with prostate cancer K Yoshimura et al

146 A). The questionnaire consisted of two questions, as was 57 months in the RP group and 53 months in the follows: (1) does coughing and/or sneezing induce XRT group. During the initial 3-y follow-up period, no leakage of urine? (2) How many pairs of underwear or patient died of prostate cancer, but one patient in the RP pads do you need to use because of leakage of urine? group and one in the XRT group died of other causes. At These questions were answered using a five-grade scale. last follow-up, another patient in the RP group had died To evaluate comprehensive amount of bothersomeness due to prostate cancer and two patients in the RP group related to bowel function, we used a similar question and six in the XRT group had been lost to follow-up. with a six-point scale, ‘If you were to spend the rest of Not surprisingly, RP patients were significantly your life with your bowel symptoms just as they are now, younger, had earlier stage of disease and had lower how would you feel about that?’. We used other PSA level than those of the XRT group. In addition, RP questions on bowel bleeding, bowel irritability, and pain patients had higher scores in the ‘physical function’ around the anal area in accordance with the question- domain and several domains of sexual function. naire presented by Bordhede et al.12

Longitudinal examination of QOL during follow-up Analyses and statistics Patterns of alteration of most domains of QOL differed At baseline, comparison between the two treatment 2 between the two treatment groups (Figures 1–3). The groups was performed with an unpaired t-test or w test. ‘face scale,’ ‘physical function,’ ‘sexual desire,’ ‘overall Scores of the aforementioned dimensions of QOL were satisfaction with sex life,’ and ‘QOL of bowel function’ sequentially plotted, and alterations of them were domains were not impacted by differences between estimated longitudinally in the RP and XRT groups. treatment modalities. These statistical analyses were performed using a paired On the ‘face scale,’ patients had a significantly more t-test for each group, and repeated-measures analyses of positive mood after treatment than before treatment in variance (ANOVA) to compare effects of the two both groups. ‘Physical function’ tended to improve after treatments. treatment in both groups, but the differences from When we assessed the impact of initiation of second baseline were small. Prostatectomy did not affect the treatment on QOL, we compared the scores of all the ‘fatigue/malaise’ domain, but radiation therapy reduced dimensions of QOL just before initiation of second ‘fatigue/malaise.’ ‘Psychological distress’ diminished treatment and just after it using a paired t-test. P-values gradually after treatment in the RP group. However, in o0.05 were considered to indicate statistical significance. the XRT group, it diminished up to the 1-y point and increased somewhat thereafter. The ‘impact of disease’ domain improved gradually in the RP group, but again Results the point of peak improvement was 3 months after treatment in the XRT group. Study population Sexual functions, which were evaluated using ‘sexual problems’ in the EORTC-P and SMUSM, exhibited Although most questions at any time point were similar patterns of change during follow-up in the two answered by over 80% of the study population, the groups. Just after initiation of treatment, all domains answering rates for questions regarding sexual function except ‘overall satisfaction’ had deteriorated in the XRT were generally low, at 50–70%. The demographic group. In the RP group, ‘sexual problems’ were worse at characteristics of the patients are presented in Table 1. 3 months after surgery, were somewhat improved at the Median follow-up after initiation of primary treatment 1-y point, and then maintained the same level up to the 3-y point. In the XRT group, initial deterioration in this domain was maintained thereafter. In other domains of Table 1 Patient characteristics sexual function and bothersomeness, except for ‘overall RP (N ¼ 84) XRT (N ¼ 51) P-value satisfaction,’ similar tendencies were observed in both groups. On the other hand, regarding ‘overall satisfac- Age (y) 66.0 (5.8) 73.2 (5.8) o0.001 tion,’ no regain was observed after initial deterioration in PSA 12.0 (13.2) 47.4 (83.2) o0.001 the RP group, and significant deterioration was noted 2 y T stage o0.001 after radiation in the XRT group. 1c 66 2 2102In the RP group, ‘physical symptoms’ were unchanged 38473 months after surgery, but improved thereafter. In the Gleason’s sum XRT group, they improved early after initiation of o75927NStreatment, but deteriorated during the third year of 72218follow-up. While the score for urinary satisfaction 4756assessed by I-PSS QOL score did not change at the 3- Comorbidities Hypertension 20 22 month point, significant improvement was observed Cardiac disease 15 12 thereafter in the RP group. On the other hand, each result Pulmonary disease 17 8 for stress incontinence and pad use significantly deterio- Gastrointestinal disease 39 20 rated after surgery. The average scores for ‘stress Cerebral disease 4 9 incontinence’ were 0.1 at baseline, 0.8 at 3-months Orthopedic disease 15 4 (Po0.001, vs baseline), 0.5 at 1-y (P ¼ 0.042, vs 3-month), Diabetes mellitus 12 13 Other malignancy 9 5 and 0.5–0.6 thereafter. The average scores for ‘pad use’ were 0.0 at baseline, 0.5 at 3-months (Po0.001, vs

Prostate Cancer and Prostatic Diseases Quality of life in patients with prostate cancer K Yoshimura et al 147

Figure 1 Face Scale and domains in EORTC-P. FS: Face Scale (possible range 1–5), PF: Physical Function (8–16), FM: Fatigue/Malaise (6–24), SP: Sexual Problems (3–12), PD: Psychological Distress (5–20), ID: Impact of Disease (2–8). P-values in the graphs indicate significance of differences between the RP and XRT groups, as determined by repeated-measures ANOVA. Arrows indicate directions toward better QOL. *Po0.05 vs baseline, **Po0.01 vs baseline.

Figure 2 Domains in SMUSM. SD: Sexual Desire (possible range 0–10), EF: Erectile Function (0–10), SS: Satisfaction after Sex (0–5), SA: Sexual Activity (0–5), OS: Overall Satisfaction with Sex Life (0–5). P-values, arrows, *, and ** as in Figure 1. baseline), 0.2 at 1-y (P ¼ 0.002, vs 3-month), and 0.1–0.2 period. In XRT patients, the score for ‘bowel bleeding’ thereafter. In the XRT group, rapid improvement after marginally increased from 1.0 at baseline to 1.2 at 1–3 y therapy was maintained throughout the follow-up in after treatment (P ¼ 0.055–0.064). comprehensive QOL related to urination. The scores for ‘stress incontinence’ and ‘pad use’ did not change during the study period. Impact of initiation of second treatment There was no alteration throughout the follow-up in either group in comprehensive QOL related to bowel Of 84 RP patients, 21 suffered from PSA failure and all function. For RP patients, the three individual scores for underwent second treatment. In total, 16 patients bowel symptoms exhibited no change during the study received radiation to the vesico-urethral anastomosis

Prostate Cancer and Prostatic Diseases Quality of life in patients with prostate cancer K Yoshimura et al 148

Figure 3 Urinary and bowel functions. SI: Stress Incontinence (possible range 0–4), PU: Pad Use (0–4), QOL-u: I-PSS QOL score (0–6), BB: Bowel Bleeding (1–4), FD: Frequent Defecation (1–4), AP: Anal Pain (1–4), QOL-b: Overall Satisfaction with Bowel Condition (0–6). P-values, arrows, *, and ** as in Figure 1.

Table 2 Impact of initiation of second treatment on QOL the two treatment groups undergoing second treatment (data not shown). In addition, there was no difference in QOL measures (range) Just (s.d.) Just (s.d.) P-values any domain at any points of time between the 36 patients before after with second treatment and the other 99 patients (data not Face Scale (1–5) 2.1 (0.7) 2.2 (0.7) 0.4 shown).

EORTCP Physical function # (8–16) 15.1 (1.8) 15.0 (2.0) 0.4 Physical symptoms (9–34) 10.0 (1.5) 10.0 (1.5) 0.4 Discussion Fatigue/malaise (6–24) 10.2 (3.0) 10.3 (2.7) 0.5 Sexual problems (3–12) 8.9 (2.9) 8.9 (2.8) 0.5 Longitudinal studies of QOL allow clinicians and Psychological distress (5–20) 7.4 (2.6) 7.4 (2.6) 0.5 patients to determine the impact of treatment on QOL Impact of disease (2–9) 2.8 (1.3) 2.7 (1.0) 0.3 over time, and to make reasonable comparisons of 13 SMUSM various treatments. They can greatly aid the informed Sexual desire # (0–10) 2.0 (2.1) 2.2 (2.1) 0.4 decision-making process. RP and external beam radia- Erectile function # (0–10) 1.3 (1.6) 1.3 (1.6) 0.5 tion therapy are the two most prevalent treatment Satisfaction after sex # (0–5) 1.0 (1.5) 1.0 (1.4) 0.5 modalities for localized prostate cancer in Japan. Sexual activity # (0–5) 0.5 (1.0) 0.5 (0.9) 0.5 Although the final choice of treatment modalities Overall satisfaction with sex 1.1 (1.1) 1.1 (1.1) 0.5 belonged to patients, many patients with locally ad- life # (0–5) vanced cancer underwent XRT in our series, as shown in I-PSS QOL (0–6) 2.0 (1.7) 1.7 (1.4) 0.2 Table 1. Since phase III studies with large cohorts demonstrated that combination therapy with radiation Overall satisfaction with 1.8 (1.5) 1.9 (1.4) 0.4 and hormone improved the survival of patients with bowel function (0–6) locally advanced prostate cancer compared with radia- 14,15 #Higher scores indicated better QOL outcomes. tion monotherapy, we routinely used neoadjuvant On the other domains without the mark #, lower scores indicated better QOL LHRH analogue therapy prior to radiation therapy. Our outcomes. patients received only 66 Gy of radiation, since conformal radiation is not available in our institute. In Japan, few institutes have equipment for conformal radiation. and five received hormone therapy. Median time to Our prospective study, despite its small population, initiation of second treatment from prostatectomy was 13 revealed sequential alterations of QOL, both generic and months. Of 51 XRT patients, 27 suffered from PSA disease-specific, induced by the two different treatment failure. Of these 27 patients, 15 underwent second modalities. Generic QOL analyses, using the four treatment during the study period, and the others were domains included in the EORTC-P, ‘physical function,’ placed under observation. The second therapy for these ‘fatigue/malaise,’ ‘psychological distress,’ and ‘impact of 15 patients was hormone therapy. Median time to second disease’ plus the ‘face scale,’ exhibited similar trends in therapy from termination of XRT was 26 months. change over time in the two treatment groups. In RP There were no changes in any domain of QOL after patients, ‘face scale,’ ‘psychological distress,’ and ‘impact initiation of second treatment (Table 2). This finding was of disease’ scores gradually but significantly improved noted for RP patients, XRT patients, and all 36 patients of up to 1–2 y after surgery and maintained levels

Prostate Cancer and Prostatic Diseases Quality of life in patients with prostate cancer K Yoshimura et al thereafter. These improvements of mainly psychological decreased thereafter. This finding indicates that patients 149 domains were compatible with those observed in the undergoing RP are more satisfied with their urinary study of Lee et al16 using the Functional Assessment of condition after 1 y after surgery. Lee et al16 reported that Cancer Therapy-Prostate questionnaire (FACT-P). How- I-PSS total score was significantly lower 1 y after RP than ever, Schapira et al17 reported in their study using the SF- at baseline, although they did not assess QOL related to 36 that role-physical function exhibited a significant urinary condition by I-PSS QOL score. Steineck et al24 decline at 3 months after prostatectomy and that other reported that the percentage of patients with moderate- domains exhibited no change from baseline up to 1 y to-severe I-PSS scores was lower in a prostatectomy after prostatecotmy. Other studies using the SF-36 also group than in a watchful-waiting group, while the reported overall stability in generic domains.6,18–21 These percentage of patients with moderate-to-severe distress differences in findings from ours may be due to the related to urinary condition was higher in the prosta- differences in instruments used for testing. The SF-36 tectomy group than in the watchful-waiting group. may not be sensitive in assessing the generic QOL of Recently, Masters and Rice25 reported that there was a patients with localized prostate cancer. In our study, very significant increase in flow rate and decrease in I- ‘physical function’ exhibited changes similar to those of PSS after prostatectomy. On the other hand, studies using the psychological domains mentioned above, but its the UCLA PCI concluded that RP impaired urinary degree of change was marginal. We cannot explain why condition.17–20 This discrepancy with regard to our only the ‘fatigue/malaise’ domain remained unchanged findings was due in part to the difference in instruments throughout the follow-up period in this situation. All of used. Although the UCLA PCI focuses on symptoms of the domains evaluated, including not only generic ones irritability and incontinence, it is likely that patients with but also urinary, bowel, and sexual ones, exhibited no prostate cancer are bothered by bladder outlet obstruc- change from the 2- to the 3-y point in RP patients. This tion as well as symptoms of irritability. Since results for finding suggests that the QOL status of RP patients our other questions on urinary continence revealed becomes stable by 2 y after prostatectomy. significant deterioration of incontinence after RP, it In XRT patients, the patterns of change over time appeared that release from bladder outlet obstruction appeared to be more complex than those in the RP group. greatly contributed to improvement of QOL related to Most generic QOL domains improved after treatment. urinary condition. XRT patients had earlier improvement However, ‘impact of disease’ and ‘psychological distress’ of QOL related to urinary condition. While the decrease exhibited significant declines during the first and second of I-PSS QOL score continued up to the 3-y point, follow-up years, respectively. As mentioned below, the ‘physical symptom’ score slightly, but significantly, ‘physical symptom’ domain exhibited similar changes. deteriorated during the second year of follow-up. These findings suggest that longitudinal QOL evaluation Regarding bowel function, overall satisfaction of after radiation requires a period longer than 2 y, which patients was unchanged during this study period in may be sufficient for QOL examination after prostatect- both the RP and XRT groups. Results for the question on omy. bowel bleeding revealed marginal deterioration in the In bothersomeness related to sexual function, RP XRT group. Although this finding was compatible with patients exhibited the typical time course of change the findings reported in previous studies using the reported in previous studies.19,22,23 Rapid declines after UCLA PCI,17–21 the finding of stability of comprehensive surgery were followed by some improvement thereafter, QOL related to bowel condition in XRT patients may but scores did not return to baseline levels. Several again be due to differences in instruments used. previous studies with the UCLA-PCI revealed similar Although the UCLA PCI focuses on irritable bowel trends,19,22,23 and we conclude that this pattern of symptoms, many individuals in the general population longitudinal change is typical of RP. In our study, XRT suffer from constipation. Overall satisfaction related to patients exhibited rapid declines of sexual function and bowel condition may depend both on irritable bowel increase in bothersomeness, and levels did not change symptoms and constipation. thereafter. Litwin et al22 reported that patients under- In 1996, when this study was initiated, no validated going radiation experienced comparable improvement Japanese questionnaire on urinary continence and bowel during the first year and a modest but significant decline symptoms for assessment of the conditions of patients during the second year in sexual function. Schapira et al17 with prostate cancer was available. We therefore pre- reported gradual decline in sexual function up to 2 y pared two questions for urinary continence and utilized despite lack of change in sexual bothersomeness in three questions for bowel symptoms in accordance with patients undergoing radiotherapy. In the study by the questionnaire presented by Borghede et al.12 Since Lubeck et al,18 radiotherapy had no impact on sexual they were not validated for use, the results obtained with function and bothersomeness but hormonal therapy them were not conclusive but nevertheless meaningful, induced marked decline in sexual function. Since our as described above. XRT cohort underwent LHRH analogue therapy prior to When follow-up continues for a long period of time, radiotherapy, rapid deterioration followed by stability some fraction of patients experience failure of primary can be explained as the combined effect of transient treatment. It is very important to assess the impacts on androgen deprivation therapy and radiation therapy. QOL of treatment failure and initiation of salvage For assessment of urinary function and bothersome- treatment. In our series, 48 were diagnosed with PSA ness, in our study the scores of part of the ‘physical failure after primary treatment and 36 of them under- symptom’ domain in the EORTC-P and I-PSS QOL were went second therapy. Our study revealed no significant used as indicators. In RP patients, these indicators impact on QOL of the initiation of second treatment, but moved similarly during follow-up. The score at 3-months we can conclude nothing from this finding due to the did not differ from that at baseline, but significantly small sample size, which makes avoidance of Type 2

Prostate Cancer and Prostatic Diseases Quality of life in patients with prostate cancer K Yoshimura et al 150 error impossible (data not shown). Further examination 13 Penson DF, Litwin MS, Aaronson NK. Health related quality of of this issue with a larger sample size is warranted. life in men with prostate cancer. JUrol2003; 169: 1653–1661. Recently, Lubeck et al26 reported that patients requiring 14 Pliepich MV et al. Phase III trial of androgen suppression using salvage therapy after radical prostatectomy had poorer goserelin in unfavorable-prognosis carcinoma of the prostate QOL than those without salvage therapy at all points treated with definitive radiotherapy: report of radiation therapy during follow-up. Our data are not consistent with their oncology group protocol 85-31. J Clin Oncol 1997; 15: 1013–1021. 15 Bolla M et al. Improved survival in patients with locally findings. advanced prostate cancer treated with radiotherapy and There are several limitations to our study. This study goserelin. N Engl J Med 1997; 337: 295–300. was based on a relatively small population, and 16 Lee WR et al. A prospective quality-of-life study in men with assessment of disease-specific QOL, especially regarding clinically localized prostate carcinoma treated with radical urinary and bowel conditions, was insufficient. Owing to prostatectomy, external beam radiotherapy, or interstitial bra- this limitation, potential differences between groups may chytherapy. Int J Radiat Oncol 2001; 51: 614–623. not have been detected. When we started this study in 17 Schapira MM et al. Effect of treatment on quality of life among April 1996, no validated questionnaire on localized men with clinically localized prostate cancer. Med Care 2001; 39: prostate cancer with a Japanese translation was available 243–253. 18 Lubeck DP et al. Changes in health-related quality of life in the other than the EORTC-P. However, this instrument, first year after treatment for prostate cancer: results from together with the I-PSS QOL score, yielded several CaPSURE. Urology 1999; 53: 180–186. findings other than those obtained with the UCLA PCI 19 Potosky AL et al. Health outcomes after prostatectomy or and SF-36. Since there is no single perfect questionnaire radiotherapy for prostate cancer: results from the prostate regarding QOL issues and different tools disclose cancer outcomes study. J Nail Cancer Inst 2000; 92: 1582–1591. different aspects of QOL, it is useful to have various 20 Bacon CG, Giovannucci E, Testa M, Kawachi I. The impact of options available for evaluation of the QOL of patients. cancer treatment on quality of life outcomes for patients with localized prostate cancer. JUrol2001; 166: 1804–1810. 21 Galbraith ME, Ramirez JM, Pedro LW. Quality of life, health outcomes, and identity for patients with prostate cancer in five Acknowledgements different treatment groups. Oncol Nurse Forum 2001; 28: 551–560. 22 Litwin MS et al. Sexual function and bother after radical We thank Drs Hiroshi Maeda, Takashi Okada, Kazutoshi prostatectomy or radiation for prostate cancer: multi- Okubo, Yoshitaka Aoki, Shinnya Maekawa, Yosuke variate quality-of-life analysis from CaPSAURE. Urology 1999; Matsuta, Nobufumi Ueda, Naoki Terada, Hiroki Ohara, 54: 503–508. Noriaki Utsunomiya, and associated nurses for their 23 Fulmer BR, Bissonette EA, Petroni GR, Theodorescu D. Prospective assessment of voiding and sexual function after assistance. This study was supported in part by a Grant- treatment for localized prostate carcinoma: comparison of in-Aid for Cancer Research from the Ministry of Health radical prostatectomy to hormonobrachyterapy with and with- and Welfare of Japan. out external beam radiotherapy. Cancer 2001; 91: 2046–2055. 24 Steineck G et al. Quality of life after radical prostatectomy or watchful waiting. 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The MOS 35-Item Short-Form Health Survey (SF-36), I: conceptual framework and item selection. Med Care 1992; 30: 473–483.  Does coughing and/or sneezing induce leakage of 6 Litwin MS et al. Quality-of-life outcomes in men treated for urine? localized prostate cancer. JAMA 1995; 273: 129–135. 0: Not at all, 1: Rarely, 2: Sometimes, 3: Fre- 7 Fossa SD et al. Quality of life and treatment of hormone resistant quently, 4: Always Eur J Cancer 26 metastatic prostate cancer. 1990; : 1133–1136.  8 Kumamoto Y. Decrease of male sexual activity by aging. Jpn J How many pairs of underwear or pads do you need to Geriatr 1992; 29: 350–360. use because of leakage of urine? 9 Isaka S et al. Assessment of the quality of life of prostate cancer 0: Not at all, 1: One or less per day, 2: Two to four patients. Nippon Hinyokika Gakkai Zasshi 1993; 84: 1611–1617. per day, 3: Five or more per day, 4: Large size 10 Lorish CD, Maisiak R. The face scale: a brief, nonverbal method diaper, always for assessing patient mood. Arthritis Rheum 1986; 29: 906–909.  If you were to spend the rest of your life with your 11 Barry MJ et al. The American Urological Association symptom index for benign prostatic hyperplasia. JUrol1992; 148: urinary symptoms just as they are now, how would 1549–1557. you feel about that? 12 Borghede G, Karlsson J, Sullivan M. Quality of life in patients 0: Delighted, 1: Pleased, 2: Mostly satisfied, 3: with prostatic cancer: results from a Swedish population study. J Mixed, 4: Mostly dissatisfied, 5: Unhappy, 6: Urol 1997; 158: 1477–1486. Terrible

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Bowel function 151  Do you have bowel or intestinal bleeding?  If you were to spend the rest of your life with your 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much bowel symptoms just as they are now, how would you  Do you need to empty your bowel more than once a day? feel about that? 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much 0: Delighted, 1: Pleased, 2: Mostly satisfied, 3:  Do you have pains in or around your anus? Mixed, 4: Mostly dissatisfied, 5: Unhappy, 6: 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much Terrible

Prostate Cancer and Prostatic Diseases