Is Radical Prostatectomy in Thai Men a High Morbidity Surgery for Localized or Locally Advanced Prostate Cancer?

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Is Radical Prostatectomy in Thai Men a High Morbidity Surgery for Localized or Locally Advanced Prostate Cancer? Sunai Leewansangtong MD*, Suchai Soontrapa MD*, Chaiyong Nualyong MD*, Sittiporn Srinualnad MD*, Tawatchai Taweemonkongsap MD*, Teerapon Amornvesukit MD* * Division of Urology, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University Objective: To assess the morbidity of radical prostatectomy in Thai patients with localized or locally advanced prostate cancer. Material and Method: A total of 151 patients with prostate cancer underwent radical prostatectomy at Faculty of Medicine Siriraj Hospital, Bangkok, between 1994 to 2003. Operative complications and long term morbidity were evaluated with clinical stage T1, T2 and T3. Results: Mean operative duration, blood loss and blood transfusion were 162 minutes (range 71-540), 1088 ml (range 200-4000) and 1.7 unit (range 0-12), respectively. Of 151 patients, 139 (92.6%) did not have perioperative complications and 42 (27.8%) did not have blood transfusion. Of 12 patients with morbidity, all patients were safely managed. There was no mortality. Of 140 patients with follow up results, 131 (93.7%) had no incontinence. Seven patients had mild stress incontinence. Only 2 patients had a significant incontinence. Eight patients had stricture of anatomosis. Strictures were simply managed with dilatation. There was no significant difference of operative time, blood loss, blood transfusion, incontinence and stricture parameters among clinical T stage (all p value > 0.05). Conclusion: Radical prostatectomy in Thai men is not a high morbidity surgery in terms of immediate complications and long term morbidity. For clinical T3 prostate cancer, morbidity is not significantly higher than in patients with clinical localized disease. Keywords: Prostate, Prostatic neoplasm, Radical prostatectomy J Med Assoc Thai 2005; 88 (12): 1833-7 Full text. e-journal: http://www.medassocthai.org/journal Correspondence to : Leewansangtong S, Division of Urology, Department of Surgery, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkoknoi, Bangkok 10700, Thailand. Phone: 0-2419-8010, Fax: 0-2411-2011, E-mail; sislt@ mahidol.ac.th At present, prostate cancer in Thailand has been changed for a decade. More prostate cancer awareness with prostate-specific antigen (PSA) and digital rectal examination (DRE) causes more prostatic biopsy procedures resulting in more early detection with clinical localized prostate cancer. Since there are many options for localized prostate cancer and each option has different side effects or different morbidity, the decision for therapy would depend on the outcomes against morbidity. Radical prostatectomy is one option therapy for clinical localized disease. Overwhelming popularity of radical prostatectomy has been addressed in Western countries for more than two decades (1). In Asia, where the incidences of prostate cancer are less than in the west, radical prostatectomy has also gained popularity (2). This includes Thailand due to more localized prostate cancer being detected (3). It is well known that the results of radical prostatectomy are excellent in terms of cancer control and survival (4). However, there is morbidity of radical prostatectomy shown in Western series (5-7). To assess the morbidity of radical prostatectomy in Thai patients, the present retrospective study was conducted. J Med Assoc Thai Vol. 88 No. 12 2005 1833

Material and Method A total of 151 patients with prostate cancer underwent radical prostatectomy at Faculty of Medicine Siriraj Hospital, Bangkok, from 1994 to 2003. Data of all patients were reviewed in both inpatient records for operative surgery and outpatient records for follow-up results by computerized database. Of 151 patients, 128 (84.9%) patients were diagnosed by transrectal ultrasound guide biopsy (TRUS). Abnormal prostate-specific antigen (PSA) level of more than 4 ng/ml and abnormal digital rectal examination (DRE) were criteria for prostatic biopsy. Twenty-three patients (15.1%) were diagnosed with incidental finding from transurethral resection prostatectomy (TURP). Gleason Score was used to classify for histological grading. The 1997 TNM classification was used for staging (8). All patients had negative bone scan. Options of therapies were made after discussion of results and morbidity between patients and physicians including urologist, radiotherapist or oncologist. Of 151 patients, 148 underwent retropubic radical prostatectomy. If the patients had low risk prostate cancer, bilateral nerve sparing radical prostatectomy was performed. Three underwent laparoscopic radical prostatectomy. Two of them were converted to retropubic radical prostatectomy. After radical prostatectomy, PSA was used to monitor for follow up. Mean time of follow up in the present series was 30 months (median = 27 months, range = 10-85 months). Eleven patients were lost to follow up. Thus, 140 patients were evaluated for follow up results. Results in terms of cancer control and survival were reported (9). Data of patients characteristic information, operative data, operative morbidity, long term morbidity and complications were evaluated with clinical stage by frequency, tables and percentage. Chi-squared test was used to compare the categorical variables. Statistical analysis (mean, median, range) was calculated by SPSS program. Results Mean age was 66.2 years (range 51 to 82 years). Table 1 shows the patients characteristic of clinical T stage, preoperative PSA and tumor grading. The mean and median of preoperative PSA were 27.3 ng/ml and 16 ng/ml, respectively (range 1.2 to 225 ng/ml). Table 2 shows operative data of radical prostatectomy. The present data shows that radical prostatectomy is an operation taking less than 3 hours, blood loss approximately 1000 ml and less than two units of blood transfusion. Table 3 shows immediate complications. Of 151 patients with radical prostatectomy, 139 (92.6%) did not have perioperative complications. Of 12 patients with morbidity, all patients were safely managed. There was no mortality in the present series. All patients with significant bleeding were operated on in the authors early experiences. At present, bleeding has become much less as we gain more experiences. Of 151 patients, 42 (27.8%) did not have a blood transfusion. Radical prostatectomy is an operation for clinical localized prostate cancer (clinical T1 or clinical T2). However, some patients with clinical T3 had potential to have benefit from radical prostatectomy in terms of local control or survival when combined to other adjuvant therapy (10). In our hospital policy, an option of therapy was discussed in terms of outcomes and morbidity between patients and physicians. The patients finally made the decisions. Of 151 patients with radical prostatectomy, 58, 63 and 52 had clinical T1, clinical T2 and clinical T3, respectively. Table 4 shows the immediate operative data of radical pros- Table 1. Distribution of patients characteristic in clinical T stage, preoperative PSA and tumor grading Patients characteristic Number patients (%) (N=151) Clinical T stage T1 58 (38.4) T2 63 (41.7) T3 30 (19.9) Preoperative PSA (ng/ml) 0-4 8 (5.3) More than 4-10 37 (24.5) More than 10-20 43 (28.5) More than 20-50 37 (24.5) More than 50 18 (11.9) Missing 8 (5.3) Gleason Score 2-4 20 (13.2) 5-7 107 (70.9) 8-10 24 (15.9) Table 2. Operative data of a total 151 radical prostatectomy Operative data Mean Median Range Operative time (minutes) 162.0 150 71-540 Blood loss (ml) 1088.0 1000 200-4000 Blood transfusion (units) 1.7 1 0-12 Hospital stay (days) 10.8 9 4-30 1834 J Med Assoc Thai Vol. 88 No. 12 2005

tatectomy among clinical T stage. Comparing the patients characteristic parameters of age, preoperative PSA level, Gleason Score, operative time, blood loss and blood transfusion, the authors found that only preoperative PSA level had a significant difference (all p values < 0.002). There was no significant difference of operative time, blood loss, blood transfusion and hospital stay among clinical T stage (all p value > 0.05). Long term morbidity of incontinence and impotence after radical prostatectomy were concerned. Results of postoperative incontinence were acceptable as shown in Table 5. Of 140 patients who had follow up results, 131 (93.7%) had no incontinence. Seven patients had mild stress incontinence. Only two patients had significant incontinence. They needed diapers. Of 140 patients, 8 patients had stricture of anatomosis. The Table 3. Immediate complications in a total of 151 patients with radical prostatectomy Complications Number patients (%) Significant bleeding up to 2000 ml 5 (3.2) Wound infection 3 (1.8) Prolonged lymphatic leakage 2 (1.2) Prolonged urinary leakage 1 (0.6) Scortal hematoma 1 (0.6) No immediate complication 139 (92.6) strictures were simply managed with dilatation. The risks of incontinence and stricture of anatomosis among patients with clinical stage T1, T2 and T3 are also shown in Table 5. Of 53 patients with clinical T1, 2 (3.7%) and 3 (5.6%) had incontinence and stricture of anatomosis, respectively. Of 60 patients with clinical T2, 4 (6.6%) and 4 (6.6%) had incontinence and stricture of anatomosis, respectively. Of 27 patients with clinical T3, 3 (8.1%) and 1 (3.7%) had incontinence and stricture of anatomosis, respectively. Comparing risks of incontinence and stricture of anatomosis among patients with clinical T1, T2 and T3, no significant differences were found (all p values > 0.2). The present data suggested that risks of incontinence and stricture of anatomosis in the patients with clinical T3 were not higher than patients with clinical T1 or patients with clinical T2. Potency after radical prostatectomy was difficult to evaluate in the present series. A lot of patients had impotence before surgery. Bilateral nerve sparing radical prostatectomy was operated on in selected patients who had low PSA and low Gleason Score. Some patients still had potency in bilateral nerve sparing radical prostatectomy. Discussion The outcome of radical prostatectomy has been well known to be excellent. However, this operation is a major surgery, morbidity and long term morbidity should be concerned. The morbidity in the Table 4. Means and standard deviations of patient s characteristic and operative data among clinical T stage Parameters Clinical T1 Clinical T2 Clinical T3 Age (years) 66.4 (+7.6) 66.7 (+5.8) 64.8 (+6.7) PSA level (ng/ml) 10.6 (+7.5) 25.5 (+25.7) 62.0 (+62.7) Gleason Score 6.0 (+1.4) 6.5 (+1.5) 7.2 (+1.4) Operative time (minutes) 156.9 (+79.1) 159.8 (+64.9) 176.0 (+51.1) Blood loss (ml) 931.98 (+590.8) 1153.2 (+775.8) 1253.3 (+565.5) Blood transfusion (units) 1.3 (+1.5) 1.9 (+2.0) 2.0 (+1.7) Hospital stay (days) 10.8 (+5.3) 11.1 (+5.3) 10.2 (+4.5) Table 5. Risks of incontinence and stricture of anatomosis after radical prostatectomy Side effects Number patients (%) Clinical T1 Clinical T2 Clinical T3 Total Incontinence 2 (3.7) 4 (6.6) 3 (8.1) 9 (6.3) No incontinence 51 (96.3) 56 (93.4) 24 (91.9) 131 (93.7) Stricture of anatomosis 3 (5.6) 4 (6.6) 1 (3.7) 8 (5.7) J Med Assoc Thai Vol. 88 No. 12 2005 1835

present series was acceptable. More than 92% of patients did not have immediate complications. Furthermore, 12 patients with morbidity were safely managed. There was no mortality. Radical prostatectomy is an operation that needs an experienced surgical team. In the authors early experience, bleeding was a major morbidity. As we have gained more experience, bleeding has been less. Median blood transfusion was 1 unit and more than 27% of patients did not have a blood transfusion. In the patients who had auto blood transfusion, they did not need a blood transfusion from other people. This could decrease the risks of blood transmitted infections. Not only blood loss, but also duration of surgery was decreased when we gained more experience. Median duration of surgery was 2 hours and 30 minute. This was not too long for major surgery. There were no complications of anesthesia in the present series. The present data suggested that radical prostatectomy does not have a high morbidity in terms of immediate complications. For long term morbidity of incontinence and stricture of anastomosis, the authors found that the risks of incontinence and stricture were acceptable. More than 93% of patients had no incontinence. Importantly, most patients who had incontinence had mild stress incontinence. The patients could soon be back to normal living as usual. Only 2 patients from 151 patients had significant incontinence that bothered their quality of life. Eight patients from 151 patients had stricture of anastomosis. Fortunately, it could be treated with dilatation. However, some patients needed to be dilated more than one time. Overall the present results of incontinence and stricture were satisfactory as well as Western series. (6) Impotence is another concern for patients with radical prostatectomy. It was a disadvantage issue for the present series. Impotence was very difficult to evaluate in the presented patients since lots of the patients had some degree of impotence before surgery. Bilateral nerve sparing radical prostatectomy underwent in selected patients who had low risk prostate cancer and good potency. PSA less than 10 ng/ml, low Gleason Score and clinical T1 or T2 were criteria for bilateral nerve sparing radical prostatectomy. However, some patients maintained potency status after bilateral nerve sparing radical prostatectomy. Radical prostatectomy is standard therapy for clinical localized disease. For clinical T3, radical prostatectomy is an option for selected patients. Benefit should be discussed against morbidity that clinical T3 would have a higher morbidity than clinical localized disease. Comparing morbidity among clinical T1, T2 and T3, the authors found that there was no significantly different morbidity in terms of both immediate complications and long term morbidity. For blood loss, radical prostatectomy in the patients with clinical T3 seemed to be more than in the patients with clinical T1 and clinical T2. However, this was not statistical significant difference. For long term morbidity, incontinence and stricture in the patients with clinical T3 was less than 10%. These were also not significantly different. Conclusion Radical prostatectomy in Thai men is not a high morbidity surgery in terms of immediate complications and long term morbidity. It maintains an excellent option for clinical localized prostate cancer. For clinical T3 prostate cancer, radical prostatectomy can be done in selected patients. Morbidity in the patients with clinical T3 is not significantly higher than in the patients with clinical localized disease in terms of immediate complications and long term morbidity. References 1. Walsh PC. Anatomic radical prostatectomy: evolution of the surgical technique. J Urol 1998; 160: 2418-24. 2. Arai Y, Egawa S, Tobisu K, Sagiyama K, Sumiyoshi Y, Hashine K, et al. Radical retropubic prostatectomy: time trends, morbidity and mortality in Japan. BJU Int 2000; 85: 287-94. 3. Leewansangtong S, Tantiwong A, Ratanarapee S, Nualyong C, Soontrapa S. The risks of prostate cancer detection by transrectal ultrasound guide biopsy in Thai men with abnormal prostate-specific antigen or abnormal digital rectal examination. J Med Assoc Thai 2000; 83: 1519-24. 4. Zincke H, Oesterling JE, Blute ML, Bergstralh EJ, Myers RP, Barrett DM. Long-term (15 years) results after radical prostatectomy for clinically localized (stage T2c or lower) prostate cancer. J Urol 1994; 152:1850-7. 5. Walsh PC. Anatomic radical retropubic prostatectomy. In: Walsh PC, Retik AB, Vaughan ED Jr, Wein AJ, editors. Campbell s urology. 8 th ed. Philadelphia: WB Saunders, 2002: 3107-29. 6. Steiner MS, Morton RA, Walsh PC. Impact of anatomical radical prostatectomy on urinary continence. J Urol 1991; 145: 512-5. 7. Quinlan DM, Epstein JI, Carter BS, Walsh PC. Sexual function following radical prostatectomy: influence of preservation of neurovascular bundles. J Urol 1991; 145: 998-1002. 1836 J Med Assoc Thai Vol. 88 No. 12 2005

8. Flemming ID, Cooper JS, Hemson DE. American joint committee on cancer staging manual. 5 th ed. Philadelphia: Lippincott; 1997: 219-22. 9. Leewansangtong S, Soontrapa S, Nualyong C, Srenualnad S, Taweemonkongsap T, Amornvesukit T. Outcomes of radical prostatectomy in Thai men with prostate cancer. Asian J Surg 2005; 28: 286-90. 10. Ward JF, Slezak JM, Blute ML, Bergstralh EJ, Zincke H. Radical prostatectomy for clinically advanced (ct3) prostate cancer since the advent of prostate-specific antigen testing: 15-year outcome. BJU Int 2005; 95: 751-6. การผ าต ดต อมล กหมากออกท งหมดในผ ป วยชายไทยท เป นโรคมะเร งต อมล กหมากระยะท ย งไม ล กลาม และระยะท ล กลามเฉพาะท ม ความเส ยงส งหร อไม ส น ย ล ว นแสงทอง, ส ชาย ส นทราภา, ไชยยงค นวลยง, ส ทธ พร ศร นวลน ด, ธว ชช ย ทว ม นคงทร พย, ธ ระพล อมรเวชส ก จ ว ตถ ประสงค : เพ อศ กษาความเส ยงของการผ าต ดต อมล กหมากออกท งหมด (radical prostatectomy) ในชายไทย ท เป นมะเร งต อมล กหมากในระยะท ย งไม ล กลามหร อระยะล กลามเฉพาะท ว สด และว ธ การ: ศ กษาผ ป วยมะเร งต อมล กหมาก จำนวน 151 คนท ได ร บการผ าต ดต อมล กหมากออกท งหมด ในโรงพยาบาลศ ร ราช ต งแต ป พ.ศ. 2537 จนถ งป พ.ศ. 2546 ความเส ยงและภาวะแทรกซ อนในระยะผ าต ด หร อ หล งผ าต ด และผลข างเค ยงระยะยาว ได ถ กนำมาว เคราะห ก บระยะของโรคทางคล น ก T 1, T 2 และ T 3 ผลการศ กษา: ระยะเวลาในการผ าต ดโดยเฉล ย 162 นาท เส ยเล อดขณะผ าต ดเฉล ย 1,088 ม ลล ล ตร ได ร บการถ าย เล อดเฉล ย 1.7 ย น ต ในจำนวนผ ป วย 151 ราย พบว า 139 ราย (92.6%) ไม ม ภาวะแทรกซ อนในขณะผ าต ด หร อหล งผ าต ด ผ ป วยจำนวน 42 ราย (27.8%) ไม จำเป นต องได ร บการถ ายเล อด ผ ป วย 12 ราย ท ม ภาวะแทรกซ อน สามารถได ร บการแก ไขอย างปลอดภ ย ไม ม ผ ป วยรายใดเส ยช ว ตจากการผ าต ด ในจำนวนผ ป วย 140 ราย ท ได ร บ การต ดตามผลการร กษาพบว า 131 ราย (93.7%) สามารถกล นป สสาวะได ผ ป วย 7 รายกล นป สสาวะไม ได แบบ Stress ซ งเป นเพ ยงเล กน อย ม ผ ป วยจำนวน 2 ราย ท ม ภาวะการกล นป สสาวะไม ได อย างช ดเจนท รบกวนช ว ตประจำว น ม ผ ป วยจำนวน 8 ราย ท ม ภาวะ การอ ดก นของรอยต อระหว างกระเพาะป สสาวะและท อป สสาวะ แต สามารถร กษา โดยง ายโดยการขยายท อป สสาวะ เม อเปร ยบเท ยบความเส ยงของการผ าต ดและผลข างเค ยงในระยะยาวของ การผ าต ดในผ ป วยระยะของโรคทางคล น ก T 1, T 2 และ T 3 พบว าไม ม ความแตกต างก น สร ป: การผ าต ดต อมล กหมากออกท งหมดในผ ป วยชายไทยท เป นมะเร งต อมล กหมาก ไม เป นการผ าต ดท ม ความเส ยง ส งในเร องของภาวะแทรกซ อนหล งผ าต ดและผลข างเค ยงระยะยาว การผ าต ดต อมล กหมากออกท งหมดในผ ป วยระยะ ของโรคทางคล น ก T 3 ไม ได ม ความเส ยงมากกว าการผ าต ดล กหมากออกท งหมดในผ ป วยระยะของโรคทางคล น ก T 1 และ T 2 J Med Assoc Thai Vol. 88 No. 12 2005 1837