Japanese Journal of Clinical Oncology Advance Access published online on July 11, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn059
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© The Author (2008). Published by Oxford University Press. All rights reserved
A Prospective Longitudinal Study Comparing a Radical Retropubic Prostatectomy and Permanent Prostate Brachytherapy Regarding the Health-related Quality of Life for Localized Prostate Cancer
1 Department of Urology
2 Radiation Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
For reprints and all correspondence: Katsuyoshi Hashine Department of Urology, National Hospital Organization Shikoku Cancer Center, 160 Minamiumemoto, Matsuyama 791-0280, Japan. E-mail: khashine{at}shikoku-cc.go.jp
Received March 27, 2008; accepted June 11, 2008
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Abstract |
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Objective: The health-related quality of life (HRQOL) after a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) was prospectively compared at a single institute.
Methods: Between 2003 and 2005, 122 patients were treated by RRP and 82 patients were treated by PPB. A QOL survey was completed at baseline, and 1, 3, 6 and 12 months after treatment, prospectively.
Results: The general HRQOL was not different between the RRP and PPB groups after 3 months. However, at 1 month after treatment, the general HRQOL scores, except for general health, were significantly better in the PPB group than that in the RRP group. Moreover, the disease-specific QOL was worse in urinary and sexual functions in the RRP group. Urinary function in the RRP group had not recovered to baseline after 12 months. Although the urinary function in the PPB group was better than that of the RRP group, urinary bother continued to worsen until 6 months and thereafter it recovered gradually. The bowel function was not worse in the PPB group but bowel bother was worse at 6 months in the PPB group. In the RRP group, the patients with nerve sparing demonstrated better in sexual function than those without nerve sparing, but the recovery did not reach the level of the PPB group.
Conclusions: This prospective study revealed the differences in the QOL after RRP and PPB. These results will be helpful for making treatment decisions.
Key Words: quality of life • localized prostate cancer • radical retropubic prostatectomy • permanent prostate brachytherapy
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INTRODUCTION |
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TOPAbstractINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Localized prostate cancer has traditionally been treated by radical prostatectomy or radiotherapy. The treatment outcomes of these treatments for low-risk localized prostate cancer are the same in recently published retrospective studies (1,2). Therefore, the decision of treatment depends on the patient’s or the oncologist’s preference. It is difficult for patients to decide which treatment should be selected if the treatment outcome is the same. One consideration in the treatment selection is the quality of life (QOL) after treatment, and the QOL is a very important factor for patients. Overall, there are few changes in the general health-related QOL (HRQOL) after a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) (3–5). However, the disease-specific QOL, especially the bowel function and urinary irritative symptom, is worse in the PPB group, and urinary incontinence and sexual function are worse in the RRP group (3). In Japan, PPB was started at 2003 and this treatment is now rapidly expanding (6). However, there are few reports describing the results after PPB and no report comparing a RRP and PPB in one institute (7). We evaluated the QOL after RRP and PPB.
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METHODS |
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TOPAbstractINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Between January 2003 and July 2005, 213 patients were treated by either RRP or PPB for localized prostate cancer. RRP was performed in 131 patients and PPB in 82 patients at our institution. The patients, who indicated RRP or PPB, selected their own therapy themselves and we did not recommend which therapy was better. The indications for RRP are age 75 years or younger, T1 to T2, any Gleason score and no limit of the prostate-specific antigen (PSA) level. Clinical stage T3 was also indicated for surgery, but the Gleason score and PSA level were carefully considered and related to the patients. The nerve-sparing technique was performed if the patient wanted sexual function. The indications for a nerve-sparing procedure depended on the preoperative (number and Gleason score of the positive biopsy cores, PSA level or patient preference) and intraoperative factors, prioritizing cancer control. The RRP was performed using Walsh’s technique by two urologist staff or under their supervision. Each surgeon had considerable experience with the retropubic approach before the beginning of the study.
On the other hand, the indications for PPB were T1c to T2, Gleason score 7 (primary grade 3) and PSA under 20 ng/ml. If the PSA level was between 10 and 20 ng/ml, and/or the Gleason score 4 + 3, additional external beam radiotherapy (EBRT) was recommended and considered. The patients treated with PPB received 145 Gy to the prostate with an I-125 seed using a modified peripheral loading technique via a transrectal ultrasound guided transperineal approach (6). During this study, we performed PPB by the pre-planned method.
We measured the general and prostate-specific HRQOL using two types of instruments. The general HRQOL was assessed by the Medical Outcomes Study 36-Item Short Form (SF-36) (8). The general scales cover eight domains: four physical and four emotional. The prostate-specific HRQOL was assessed by the University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI), and a 20-item questionnaire quantifies the prostate cancer-specific HRQOL in six separate domains (9). All patients were informed of their cancer diagnosis before being asked to complete the HRQOL questionnaires. No interviews were conducted. Every patient, who agreed to participate in this study, received a questionnaire, an informed consent form and a prepaid envelope for returning the questionnaire to their urologist. The questionnaires were administered at five time points. The baseline survey was conducted within 1 week before surgery and PPB. The follow-up survey was conducted in a person at the scheduled study visits at 1, 3, 6 and 12 months after treatment.
All scales of the SF-36 and UCLA-PCI were linearly transformed to a scale of 0 (lowest) to 100 (highest). Each group comparison was made using the Mann–Whitney U-test and chi-square test. P < 0.05 was considered to be significant. This study was approved by the Institutional Review Board in our hospital. Written informed consent was obtained from all patients before the initiation of treatment.
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RESULTS |
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The surveys were returned by 122 and 82 men who underwent RRP or PPB, respectively. The average answer rate of each survey was 70.8% in RRP and 76.1% in PPB. The median age of the RRP group was 68.0 years and that of the PPB group was 70.5 years. As for the age, the RRP group was younger than the PPB group. As for the clinical stage and PSA level, the PPB group had a lower stage and a lower average PSA level. In addition, the Gleason score was lower in the PPB group. Neoadjuvant androgen deprivation therapy was performed in 18 patients from the PPB group and in eight patients from the RRP group. All of these patients discontinued hormone therapy after RRP or PPB. Nerve-sparing surgery was performed in 22 patients. Only one patient used EBRT in PPB. After 12 months, nine patients demonstrated recurrence in RRP and one patient in PPB. The former was PSA failure only (PSA above 0.2 ng/ml) and the latter was clinical failure (lymph node metastasis) (Table 1). However, the general and disease-specific QOL among these recurrence patients in both groups was the same as in patients without the recurrence. We therefore included all cases in this analysis.
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The general HRQOL scores are listed in Table 2. There is no significant difference for the baseline QOL scores in each group except for in mental health. Mental health was worse in the RRP group than in the PPB group. In the RRP group, the QOL scores at 1 month were worse than the baseline score except for that of general health and mental health. These worse scores recovered until 3 months, but the score of role physical and body pain remained worse at 3 months. Only the mental health score improved over the baseline after 3 months. In the PPB group, the QOL scores did not change except for body pain and mental health. Mental health improved above the baseline at 6 months. Comparing the RRP and PPB, there were significant differences in the physical function, role physical, body pain, vitality, social function, role emotion and mental health at 1 month after treatment. These QOL scores were better in the PPB group than in the RRP group. The general health was the only area with the same score at 1 month in both the groups. After 3 months, the QOL score recovered gradually and there were no significant differences between the RRP and PPB groups.
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The results of the UCLA-PCI are listed in Table 3. For the baseline score, there was no significant difference between the RRP and PPB groups except for urinary function that was worse in the RRP group at baseline. At 1 month, the urinary function, urinary bother, bowel function, sexual function and sexual bother were worse in the RRP group than in the PPB group. The urinary function, sexual function and sexual bother in the RRP group were worse than in the PPB group until 12 months. Urinary bother was not different after 3 months in each group. The degree of bowel bother was not different, but at 6 months the PPB group was worse than the RRP group. In the RRP group, urinary function, urinary bother, bowel function and bowel bother had returned to baseline after 6 months, but urinary function had not returned to baseline at 12 months. Sexual function did not recover. In the PPB group, the change of the QOL scores was mild and recovery was soon in comparison to the RRP group. Only urinary bother was worse up until 6 months. Moreover, the sexual function did not change in the PPB group.
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Concerning sexual function and bother, the effect of nerve sparing was examined. In the RRP group, if nerve sparing was performed, sexual function recovered gradually better than in the non-nerve-sparing group. However, the nerve-sparing group did not recover to the baseline at 12 months. On the other hand, sexual bother was worse in the nerve-sparing group than in the non-nerve-sparing group. Comparing the PPB group, the sexual function was worse in the nerve-sparing and non-nerve sparing groups, except for the nerve-sparing group at 12 months. Sexual bother was also worse in each group (Table 4).
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DISCUSSION |
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TOPAbstractINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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There are several treatment options for localized prostate cancer, such as surgery, EBRT and PPB. Which treatment is selected is due to the preference of the oncologist or the patient. However, the treatment outcomes have recently been reported to be equal and good for low-risk localized prostate cancer between both surgery and radiotherapy (1,2). As a result, the QOL after treatment has therefore become increasingly important.
In Japan, PPB was initiated in 2003 for the treatment of localized prostate cancer (6). So, the selection of treatment for localized prostate cancer was more difficult for patients and oncologists, as well. Therefore, the QOL after the treatment increased in importance, and many investigators reported on the QOL (10–12). Namiki et al. reported the general HRQOL to be mostly unaffected by RRP after 6 months despite reports of problems with sexuality and urinary continence. The RRP had a favourable impact on mental health. Although the urinary function did not completely return to the baseline level even at 2 years after the RRP, the recovery from urinary bother was rapid. The RRP had serious consequences on the libido, erectile function and sexual activity. In the second year, the sexual function of those who underwent a RRP with a bilateral nerve-sparing procedure continued to improve (11). Other investigators also reported the same results (13,14).
In this study, our results in the RRP patients were the same as those of the other investigators (10–14). The general QOL was good except at 1 month after surgery, but the disease-specific QOL was worse. The urinary function was worse because of urinary incontinence.
On the other hand, PPB began in 2003, and the results such as the QOL came to be reported in the past few years. Okaneya et al. (15) reported PPB to be a feasible and effective option for the treatment of prostate cancer in Japanese men. Urinary retention was rare, but voiding symptoms were persistent. Ohashi et al. (16) reported that IPSS after PPB peaked at 1 month and gradually returned approximately to baseline level at 12 months. The manifestations of rectal morbidity are acceptable events after PPB. The manifestations of acute urinary morbidity, especially frequency and retention, are relatively common but acceptable events after PPB.
Litwin et al. (3) reported the QOL after both RRP and PPB. They reported the general QOL to be the same in both groups, but the urinary function was better in the PPB group. Moreover, the sexual function was better in the PPB group, but bowel function was worse. Other investigators reported the same results (4,5). However, there are few reports comparing the PPB and RRP in Japan. Only one report was found by Namiki et al. (7). They concluded that the PPB and RRP groups have meaningfully different profiles in the recovery of the general QOL. The differences in the recovery of the disease-specific QOL were pronounced during the first 12 months after treatment. Our results in a single institution revealed that the general HRQOL usually recovered after 3 months in the RRP group, but this change was not observed in the PPB patients. The urinary function and sexual function were better in the PPB group than in the RRP group. In the RRP group, it is thought that urinary incontinence has an influence on most QOL scores. Therefore, the general HRQOL improves as urinary incontinence is restored. In the PPB group, urinary incontinence does not become a problem after treatment, so the QOL scores were better in the PPB group than in the RRP group. According to the sexual function and bother, the function in the RRP group was much worse but the degree of bother was not as bad. This result is different from previous reports from Western countries (3–5). The reason is because there were a few patients who underwent the nerve-sparing procedure and want to preserve their sexual function. However, in the report of Namiki et al. (7) the nerve-sparing rate was 84%, and the recovery of the sexual function was better as a result in this study. However, it was still inferior to the results of PPB.
There are some limitations associated with our study. First, the survey of the disease-specific QOL was used for the UCLA-PCI. For urinary function, the UCLA-PCI focused mainly on urinary incontinence. Therefore, urinary irritability might have been underestimated. Recently, the QOL survey varied from the UCLA-PCI to the Expanded Prostate Cancer Index Composite (EPIC) (17,18). The EPIC contained more questions for urinary and bowel function, including, for example, urinary and bowel irritation. The results from the EPIC were emphasized for urinary function. Frank et al. (19) reported that the radiation caused a significantly worse bowel function and bother than did the RRP. Although the RRP had significantly worse urinary incontinence than the PPB or EBRT, the PPB had more urinary irritation than the EBRT or RRP. The PPB had a significantly better sexual function than the EBRT or RRP. We now use the EPIC and will analyze those data in a future study. The differences in the QOL after treatment will be estimated in detail using the EPIC. Second, there were some differences in the backgrounds between RRP and PPB. This study is a prospective study not a randomized one. Indeed, the PPB group tended to have a high age, and the RRP group included more high-risk patients. If there are many high-risk patients, then recurrence and the need to perform additional treatment would also increase, thus influencing the QOL. However, because this study focused on the outcomes only until 12 months from the start of treatment, only a few patients with recurrence were thus observed and they did not affect the results. Finally, this survey was only until 12 months and the observation period was thus short. The results of the QOL may therefore change during the long-term follow-up.
Despite these limitations, the change and difference in the QOL until 12 months became clear in this study. These results and other published results will therefore be useful and provide important information when selecting the optimal treatments for localized prostate cancer, although long-term observations and further surveys are still necessary in the future.
Conflict of interest statement None declared.
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