修訂原則參與修訂科別 : 泌尿外科腫瘤治療科放射診斷科病理科血液腫瘤科診療指引需符合以下原則 : 一依據實證醫學精神, 並於指引中註明主要參考文獻 ( 至少為 peer review article), 若引用醫院之資料庫資料, 則需提供分析及討論紀錄二參酌國情並經院內共識討論,

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1 攝護腺癌診療指引 2011 年 05 月 11 日一修 2012 年 02 月 15 日二修 2013 年 02 月 20 日三修泌尿道癌醫療團隊共同修訂

2 修訂原則參與修訂科別 : 泌尿外科腫瘤治療科放射診斷科病理科血液腫瘤科診療指引需符合以下原則 : 一依據實證醫學精神, 並於指引中註明主要參考文獻 ( 至少為 peer review article), 若引用醫院之資料庫資料, 則需提供分析及討論紀錄二參酌國情並經院內共識討論, 且有相關會議紀錄佐證三定期檢視改版 ( 至少每年一次, 且明確標示制訂或修訂日期 ) 四團隊共識後所訂之指引, 應提送癌委會核備後公告

3 圖一 : 最初診斷和追蹤觀察最初篩檢診斷及分期方法依未來可能復發之危險度分期最初治療攝護腺特異性抗原 (PSA) 肛門指檢 (DRE) 前列腺超音波檢查經直腸超音波切片檢查 ( 休息 2~4 周 ) 或經尿道攝護腺切除術 ( 休息 4~6 周 ) 格里森分級系統 (Gleason grade) 腹部 X 光檢查骨盆或腹部電腦斷層攝影或腹部核磁共振攝影或骨髂掃描 (T1PSA >20 T2PSA>10 Gleason scroce 8 T3-T4 symptomatic) 極低危險 T1c GS 6 PSA<10 <3 條 corse <50% 低危險 T1-T2a GS 6 PSA<10ng/m L 中危險 T2b-T2c or GS=7 or PSA:10-20ng/mL 高危險 T3a or GS=8-10 or PSA>20ng/m L 極高危險 T3a-T4 轉移 Any T,N1 轉移 Any T Any N M1( 多發性轉移 ) 餘命 <10 年餘命年餘命 20 年餘命 <10 年餘命 10 年餘命 <10 年餘命 10 年觀察 / 積極追蹤評估若病患拒 OP 根除性攝護腺切除術 + 骨盆淋巴結切除觀察 ( 積極 ) 追蹤評估 ± 觀察直至有症狀 ( 除非高危險因子可使用 ADT 或 R/T) 觀察 / 積極追蹤評估放射線治療 (Daily IGRT with IMRT/ 3D- CRT)± short-term 荷爾蒙治療 4-6 個月根除性攝護腺切除術 ± 骨盆淋巴結切除放射線治療 (Daily IGRT with IMRT/3DCRT)+ADT(2-3 年 ) 餘命 >10 年腫瘤不大 Selected p't no fixation 荷爾蒙治療或放射線治療 (Daily IGRT with IMRT/3DCRT) + long-term 荷爾蒙治療 (2-3years) 荷爾蒙治療 ± 合併姑息性放射線治療 Active surveillance± 觀察直至有症狀 ( 除非高危險因子可使用 ADT 或 R/T) 積極追蹤評估放射線治療 (Daily IGRT with IMRT/ 3D- CRT)± short-term 荷爾蒙治療 4-6 個月根除性攝護腺切除術 + 骨盆淋巴結切除 (1)observation if clear margin, PSA 偵測不到或 < 極低值 (2)*adverse feature: R/T or OBS (3)LN meta: ADT+R/T or ADT or OBS (1)observation if clear margin (2)adverse feature: R/T or OBS (3)LN meta: ADT+RT. ADT. OBS 見圖二 * 註 : adverse feature : 腎水腫或 T3 -T4 及 Gleason scroce 8-10

4 追蹤觀察 Active surveillance 積極追蹤評估觀察每 3-6 個月檢驗 PSA 每 12 個月肛門指檢 ( 每 6 個月, 至少不超過 12 個月 ) 必要時每年切片 (TRUS) 或是 Prostate 檢查有異常改變, 或是 PSA 有持續增加但 75 歲以後或生命餘命 ( Life expectancy <10 years 例外 ) 手術或放射線治療後每 3-6 個月檢驗 PSA 持續 5 年, 之後每年檢驗 PSA 每 12 個月肛門指檢 N1/ M1 每 3-6 個月 (1) 檢驗 PSA (2) 身體理學檢查 ( 包含 DRE) 每 3 個月肝功能檢查 ( 若使用女性荷爾蒙物 Ketoconazole Cyproterone Acetate(Androcar))

5 圖二 : 治療後復發的追蹤根除性攝護腺切除後復發追蹤 PSA 無降到最低值以下或無法偵測值以下術後 PSA 數值再度升高 ( 兩次 ) Work up : ± 電腦斷層 ± 核磁共振攝影 ± 骨骼掃描 ± 前列腺切片 (TRUS Bx, 前次手術區域有異常病兆 ) Postive DRE 手術邊界陰性或陽性侵犯儲精囊或淋巴結轉移遠端轉移放射線治療 ± 荷爾蒙治療或觀察放射線治療 ± 荷爾蒙治療或荷爾蒙治療單獨使用或觀察荷爾蒙治療 ± R/T 於負重之骨轉移或有症狀之病灶或觀察見圖三荷爾蒙治療或觀察放射線治療失敗 (PSA 從最低值增加 2ng/ml 以上 ) Work up : ± 電腦斷層 ± 核磁共振攝影 ± 骨骼掃描 ±Prostate Bx Postive DRE 局部復發瀰漫性遠端轉移或攝護腺根除 Cryotherapy If life >10 年,initial T1- T2, PSA<10 ADT or observation

6 圖三 : 症狀治療 M0 or M1 預計荷爾蒙治療 Orchiectomy or LHRH agonist ±antiandrogen 7days to prevent testosterone flare or LHRH agonist +antiandrogen or LHRH antagonist 復發無遠端轉移遠端轉移 ( 懷疑小細胞癌, 則安排切片確認 ) Maintain castrate serum levels of testosterone Not small cell Clinic trial(preferred) Observation 二線荷爾蒙治療 (Ketoconazole or Antiandrogen or Steroids or DES or Estrogen) Symptomatic Yes No PSA relapse or 發現轉移化學治療 (Docetaxel.Mitoxantrone) Palliative R/T for bone metastasis Clinic trial 二線荷爾蒙治療化學治療 (Docetaxel) Clinic trial 見圖四 Small cell 化學治療 (as NCCN guideline for small cell lung cancer) (1)Cisplatin + Etoposide (2)Carboplatin + Etoposide (3)Docetaxel 安寧緩和

7 圖四 : 轉移轉移 Maintain castrate serum levels of testosterone Denosumab or zoledronic acid if bone metastases 惡化持續二線荷爾蒙治療化學治療 : Docetaxel 臨床試驗觀察安寧緩和療護

8 攝護腺癌化療處方 Chemotherapy regimen 治療目的組套編碼處方內容 Advanced Metastasis P-1-1 Docetaxel 50 mg/m 2 IV over 1hr infusion, day 1 Prednisolone 10mg, Oral daily Biweekly P Docetaxel 75 mg/m 2 IV over 1hr infusion, day 1 Repeat every 21 days Prednisolone 5mg po Bid P-3 Mitoxantrone + Prednisolone 17 Mitoxantrone 12 mg/m 2 IV over 20 minutes, day 1 Repeat every 21 days Prednisolone 5mg po Bid

9 Radiation therapy Treatment type RT technique Total dose Fraction size / # Fractions Note Radical radiotherapy Conventionally Fractionated RT 45Gy to pelvic node 54Gy to periprostate area 74-82Gy to prostate 1.8-2Gy/ fraction IGRT required if >78Gy Adjuvant radiotherapy Conventionally Fractionated RT 45Gy to pelvic node 64-68Gy to tumor bed 1.8-2Gy/ fraction Indication: 1. 手術不完整 (Postive surgical margin) 2. 腫瘤侵犯儲精囊 (Seminal vesicle invasion;svi) 3. 骨盆淋巴腺轉移 (Postive pelvic node) 4. 術前 PSA 指數很高 (Higher pre-operative PSA value) 5. 腫瘤惡性度高 (Greater Gleason score 7) 6. 腫瘤侵犯超越莢膜 (Extracapsule extension;epe) Adjuvant radiotherapy For high risk disease Salvage R/T for biological relapse Conventionally Fractionated RT IGRT 45Gy to pelvic node 70Gy to tumor bed 1.8-2Gy/ fraction 註 : 實際治療分次劑量總治療次數, 應與處方劑量差異在 ±1Gy 內註 : 放射治療詳細流程清參照攝護腺癌放射治療標準政策與執行規範註 :High risk disease:pt3 disease,postive margin,gleason score 8-10 or Seminal vesicle involvement

10 攝護腺癌 Reference 1.Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351: Buch-Hansen TZ, Bentzen L, Hansen S, et al. Phase I/II study on docetaxel, gemcitabine and prednisone in castrate refractory metastatic prostate cancer. Cancer Chemother Pharmacol. 2010;66: Harzstark AL, Rosenberg JE, Weinberg VK, et al. Ixabepilone, mitoxantrone, and prednisone for metastatic castration-resistant prostate cancer after docetaxel-based therapy: a phase 2 study of the department of defense prostate cancer clinical trials consortium. Cancer NCCN Clinical Practice Guidelines in Oncology Prostate cancer, Version Kupelian PA, et al: Radical prostatectomy, external beam radiotherapy <72 Gy, external beam radiotherapy > or = 7 Gy, permanent seed implantation, or combined seeds/external beam radiotherapy for stage T1-T2 prostate cancer. Int J Radiat Oncol Biol Phys 2004; 58: Tward JD, et al: Survival of men with clinically localized prostate cancer treated with prostatectomy, brachytherapy, or no definitive treatment. Impact of age at diagnosis. Cancer 2006; 107: Merglen A, et al: Short- and long-term mortality with localized prostate cancer. Arch Intern Med 2007; 167: Shipley WU, et al: Radiation therapy for clinically localized prostate cancer. A multi-institutional pooled analysis. JAMA 1999; 281: Kupelian PA, et al: Effect of increasing radiation doses on local and distant failures in patients with localized prostate cancer. Int J Radiat Oncol Biol Phys 2008; 71: Wiegel T, et al: Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pt3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol 2009; 27: Bolla M, et al: Postoperative radiotherapy after radical prostatectomy. A randomised controlled trial (EORTC trial 22911).Lancet 2005; 366: Roscigno M, et al: A reappraisal of the role of vesicourethral anastomosis biopsy in patient candidates for salvage radiation therapy after radical prostatectomy. Radiother Oncol 2007; 82: Horwich A, Parker C, Kataja V: Prostate cancer: ESMO clinical recommendations for diagnosis, treatment and followup.ann Oncol 2009; 20(Suppl 4):76-78.

11 攝護腺癌 Reference 14.Van Poppel H, et al: Efficacy and tolerability of radiotherapy as treatment for bicalutamide-induced gynaecomastia and breast pain in prostate cancer. Eur Urol 2005; 47: Perdona S, et al: Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer. A randomised controlled trial. Lancet Oncol 2005; 6: PROSTY study group. Pirkko-Liisa Kellokumpu-Lehtinen et al:2-weekly versus 3-weekly docetaxel to treat castractionresistant advanced prostate cancer: raddomiced phase 3 trial. Lancet Oncology 2013;14(2); Tannock IF et al:docetaxel plus prednisolone or mitoxantrone plus prednisolone for advanced prostate cancer NEJM 2004;351(15); NCCN Clinical Practice Guidelines in Oncology Prostate cancer, Version Perez and Braddy s Principle and Practice of Radiation Oncology, Fifth Edition. 20.Shih, M. Harisinghani and A. Zietman et al. Mapping of nodal disease in locally advanced prostate cancer: Rethinking the clinical target volume for pelvic nodal irradiation based on vascular rather than bony anatomy, Int J Radiat Oncol Biol Phys 63 (4) (2005), pp Gluck I, Vineberg KA, Ten Haken RK, Sandler HM, Evaluating the Relationships Between Rectal Normal Tissue Complication Probability and the Portion of Seminal Vesicles Included in the Clinical Target Volume in Intensity-Modulated Radiotherapy for Prostate Cancer, Int J Radiat Oncol Biol Phys Feb 1;73(2): Lawton CA, Michalski J, El-Naqa I, Buyyounouski MK, Lee WR, Menard C, O'Meara E, Rosenthal SA, Ritter M, Seider M. RTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer, Int J Radiat Oncol Biol Phys Jun 1;74(2):383-7.

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