一 本 共 識 依 下 列 參 考 資 料 修 改 版 本 : 1. NCCN Clinical Practice Guidelines in Oncology- Prostate cancer V

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1 一 本 共 識 依 下 列 參 考 資 料 修 改 版 本 : 1. NCCN Clinical Practice in Oncology- Prostate cancer V

2 二 制 訂 人 員 : 泌 尿 外 科 : 鍾 旭 東 醫 師 蔡 宗 佑 醫 師 洪 順 發 醫 師 腫 瘤 內 科 : 蕭 吉 晃 醫 師 放 射 腫 瘤 : 熊 佩 韋 醫 師 解 剖 病 理 : 蔡 建 誠 醫 師 影 像 醫 學 : 曾 旭 明 醫 師 黃 俊 傑 醫 師 三 guidelines 內 容 :

3 RISK GROUP Very Low: T1c Gleason sce 6 PSA <10 ng/ml Fewer than 3 prostate biopsy ces positive, 50% cancer in any ce PSA density<0.15 ng/ml/g 亞 東 紀 念 醫 院 EXPECTED PATIENT SURVIVAL 20 y INITIAL THERAPY RT Active surveillance PSA no me often than every 6 mo unless clinically indicated DRE no me often than every 12 mo unless clinically indicated Repeat prostate biopsy no me often than every 12 mo unless clinically indicated Radical prostatectomy (RP) ± pelvic lymph node dissection (PLND) if predicted probability of lymph node metastasis 2% ADJUVANT THERAPY Adverse features: RT Lymph node metastasis: ADT ± RT See Moniting (PROS-5) < 20 y Active surveillance PSA as often as every 6 mo DRE as often as every 12 mo PROS-1

4 RISK GROUP Low: T1-T2a and Gleason sce 6 and PSA < 10 ng/ml < 10 y 10 y EXPECTED INITIAL THERAPY PATIENT SURVIVAL Active surveillance RT cryotherapy Active surveillance RT RP ± PLND if predicte probability of lymph node metastasis 2% ADJUVANT THERAPY Adverse features: RT Lymph node metastasis: ADT ± RT See Moniting (PROS-5) NOTE: Organ-confined disease: Symptomatic (LUTS hematuria) high-risk patients unfit f definitive treatments (RRP, RT even TUR-P) PROS-2

5 RISK GROUP EXPECTED INITIAL THERAPY PATIENT SURVIVAL 10 y RP + PLND if predicted probability of lymph node metastasis 2% ADJUVANT THERAPY Adverse features: RT Lymph node metastasis: ADT ± RT Undetectable PSA nadir See Moniting (PROS-5) See Radical Prostatectomy Biochemical Failure (PROS- 6) Intermediate: T2b-T2c Gleason sce 7 PSA ng/ml <10 y RT ± ADT (4-6 mo) PSA failure See Radiation Therapy Recurrence (PROS-7) PROS-3

6 RECURRENCE RISK EXPECTED INITIAL THERAPY PATIENT SURVIVAL ADJUVANT THERAPY High: T3a Gleason sce 8-10 PSA >20 ng/ml RT+Long-term ADT (2-3 y) RP + PLND cryotherapy Surveillance Positive margins: RT Undetectable PSA See Moniting (PROS-5) Locally Advanced Very high: T3b-T4 Metastatic: Any T, N1 Any T, Any N, M1 RT+Long- term neoadjuvant/concomitant/adjuvant ADT(2-3 y) Long-term ADT (2-3 y) RP + PLND (in select patients: with no fixation) ADT RT + long-term neoadjuvant/concomitant/adjuvant ADT (2-3y) Long-term ADT (2-3 y)± Palliative RT Lymph node metastasis: ADT ± pelvic RT Active surveillance Positive margins: RT Lymph node metastasis: ADT Active surveillance Or ADT ± pelvic RT Detectable PSA See Moniting (PROS-) Undetectable PSA Detectable PSA See Moniting (PROS-5) See Post- Radical Prostatectomy Recurrence(PROS-6) See Moniting (PROS-5) See Post- Radical Prostatectomy Recurrence (PROS-6) PROS-4

7 INITIAL MANAGEMENT OR PATHOLOGY Initial-definitive therapy MONITORING PSA every 6-12 mo f 5 y, then every year DRE every year, but may be omitted if PSA undetectable RECURRENCE Post--RP Post-RT Failure of PSA to fall to undetectable levels (PSA persistence) Undetectable PSA after RP with a subsequent detectable PSA that increases on 2 me determinations (PSA recurrence) Rising PSA Positive DRE See Post- Radical Prostatectomy Recurrence (PROS-6 ) See Post-Radiation Therapy Recurrence (PROS-7) N1 M1 Physical exam + PSA every 3-6 mo Advanced disease See Advanced Disease (PROS-9) PROS-5

8 RADICAL PROSTATECTOMY BIOCHEMICAL FAILURE Studies negative f distant RT ± neoadjuvant/concomitant /adjuvant ADT Failure of PSA to fall to undetectable levels (PSA persistence) Undetectable PSA after RP with a subsequent detectable PSA that increases on 2 me Determinations (PSA recurrence) ± Bone Scan ± CT/MRI TRUS ± PSADT ±Prostate bed biopsy(especially Ifimaging suggest localrecurrence) Progression See Advanced Disease (PROS-8) Studies positive f distant ADT ± RT to site of if in weight-bearing bones, symptomatic Or Hospice care PROS-6

9 RADIATION THERAPY RECURRENCE TRUS biopsy positive, studies negative f distant RP Cryosurgery Biochemical failure Or Positive DRE Candidate f local therapy: Original clinical stage T1-T2, NX N0 Life expectancy >10 y PSA now <10 ng/ml Not a candidate f local therapy TRUS biopsy Bone scan ± Abdominal/pelvic CT/MRI Prostate MRI TRUS biopsy negative, studies negative f distant Studies positive f distant ADT Clinical trial Me aggressive wk-up f local recurrence (eg, repeat biopsy, MR spectroscopy, Prostate MRI) ADT Hospice care Progression See Advanced Disease (PROS-8) PROS-7

10 ADVANCED DISEASE: SYSTEMIC THERAPY Orchiectomy LHRH agonist ± antiandrogen 7 days to prevent testosterone flare Studies negative b f distant See Additional Systemic Therapy f Castration-Recurrent Prostate Cancer (PROS-9) ADT naive (M0 M1) LHRH agonist + antiandrogen LHRH antagonist Relapse Studies positive f distant Consider biopsy if small cell suspected Not small cell Small cell See Additional Systemic Therapy f Castration-Recurrent Prostate Cancer (PROS-10) Cisplatin/etoposide Carboplatin/etoposide Docetaxel-based regimen, Clinical trial PROS-8

11 ADVANCED DISEASE: ADDITIONAL SYSTEMIC THERAPY FOR CASTRATION-RECURRENT PROSTATE CANCER Studies negative f distant Maintain castrate serum levels of testosterone Clinical trial (perferred) especially if PSADT ³10 mo Secondary hmone therapy especially if PSADT <10 mo > Antiandrogen > Antiandrogen withdrawal > Ketoconazole > Cticosteroids > DES other estrogen PSA relapse, no Metastases (M1) Repeat pathway See Additional Systemic Therapy f Castration-Recurrent Prostate Cancer (PROS-10) PROS-9

12 ADVANCED DISEASE: ADDITIONAL SYSTEMIC THERAPY FOR CASTRATION-RECURRENT PROSTATE CANCER Studies positive f distant Maintain castrate serum levels of testosterone and Denosumad zoledronic acid if bone Symptomatic Yes No Mitoxantrone Palliative RT radionuclide f symptomatic bone Clinical trial Best supptive care Secondary hmone therapy > Antiandrogen > Antiandrogen withdrawal > Abiraterone acetate > Ketoconazole > Cticosteroids > DES other estrogen Docetaxel Clinical trial Abiraterone acetate enzalutamide ( post-docetaxel therapy ) Cabazitaxel (post-docetaxel) Salvage chemotherapy Docetaxel rechallenge Mitoxantrone Other secondary hmone therapy > Antiandrogen > Antiandrogen withdrawal > Ketoconazole > Cticosteroids > DES other estrogen Clinical trial Best supptive care PROS-10

13 四 Staging: T2 T3 T4 T1c T1b T2a T2b T2c T3a T3b 亞 東 紀 念 醫 院 Table 1. TNM Staging System F Prostate Cancer Primary Tum (T) Clinical TX T0 T1 T1a Primary tum cannot be assessed No evidence of primary tum Clinically inapparent tum neither palpable n visible by imaging Tum incidental histologic finding in 5% less of tissue resected Tum incidental histologic finding in me than 5% of tissue resected Tum identified by needle biopsy (e.g., because of elevated PSA) Tum confined within prostate* Tum involves one-half of one lobe less Tum involves me than one-half of one lobe but not both lobes Tum involves both lobes Tum extends through the prostatic capsule ** Extracapsular extension (unilateral bilateral) Tum invades the seminal vesicle(s) Tum is fixed invades adjacent structures other than seminal vesicles: bladder, levat muscles, and/ pelvic wall. *Note: Tum found in one both lobes by needle biopsy, but not palpable reliably visible by imaging, is classified as T1c. **Note: Invasion into the prostatic apex into (but not beyond) the prostatic capsule is not classified as T3, but as T2. *Note: There is no pathologic T1 classification. M1a M1b M1c Pathologic(pT)* pt2 Organ confined pt2a Unilateral, involving one-half of one side less pt2b Unilateral, involving me than one-half of one side but not both sides pt2c Bilateral disease pt3 Extraprostatic extension pt3a Extraprostatic extension microscopic invasion of the bladder neck** pt3b Seminal vesicle invasion pt4 Invasion of bladder, rectum **Note: Positive surgical margin should be indicated by an R1 descript (residual microscopic disease). Regional Lymph Nodes (N) Clinical NX Regional lymph nodes were not assessed N0 No regional lymph node metastasis N1 Metastasis in regional lymph node(s) Pathologic PNX Regional nodes not sampled pn0 No positive regional nodes pn1 Metastases in regional nodes(s) Distant Metastasis (M)* M0 No distant metastasis M1 Distant metastasis Non-regional lymph node(s) Bone(s) Other site(s) with without bone disease *Note: When me than one site of metastasis is present, the most advanced categy is used. pmic is most advanced. Continue Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The iginal and primary source f this infmation is the AJCC Cancer Staging Manual, Seventh Edition (2010), published by Springer Science+Business Media, LLC (SBM). (F complete infmation and data suppting the staging tables, visit Any citation quotation of this material must be credited to the AJCC as its primary source. The inclusion of this infmation herein does not authize any reuse further distribution without the expressed, written permission of Springer SBM, on behalf of the AJCC. ST-1

14 ANATOMIC STAGE/PROGNOSTIC GROUPS * Group T N M PSA Gleason I T1a-c N0 M0 PSA < 10 Gleason 6 T2a N0 M0 PSA < 10 Gleason 6 T1-2a N0 M0 PSA X Gleason X IIA T1a-c N0 M0 PSA < 20 Gleason 7 T1a-c N0 M0 PSA 10 <20 Gleason 6 T2a N0 M0 PSA < 20 Gleason 7 T2b N0 M0 PSA < 20 Gleason 7 T2b N0 M0 PSA X Gleason X IIB T2c N0 M0 Any PSA Any Gleason T1-2 N0 M0 PSA 20 Any Gleason T1-2 N0 M0 Any PSA Gleason 8 III T3a-b N0 M0 Any PSA Any Gleason IV T4 N0 M0 Any PSA Any Gleason Any T N1 M0 Any PSA Any Gleason Any T Any N M1 Any PSA Any Gleason *Note: When either PSA Gleason is not available, grouping should be determined by T stage and/ either PSA Gleason as available. Histopathologic Type This classification applies to adenocarcinomas and squamous carcinomas, but not to sarcoma transitional cell carcinoma of the prostate. Adjectives used to describe variants of prostate adenocarcinomas include mucinous, signet ring cell, ductal, adenosquamous and neuroendocrine small cell carcinoma. Transitional cell (urothelial) carcinoma of the prostate is classified as a urethral tum. There should be histologic confirmation of the disease. Histopathologic Grade (G) Gleason sce is recommended because as the grading system of choice, it takes into account the inherent mphologic heterogeneity of prostate cancer, and several studies have clearly established its prognostic value. A primary and a secondary pattern (the range of each is 1 5) are assigned and then summed to yield a total sce. Sces of 2 10 are thus theetically possible. The vast majity of newly diagnosed needle biopsy detected prostate cancers are graded Gleason sce 6 above. (If a single pattern of disease is seen, it should be repted as both grades. F example, if a single focus of Gleason pattern 3 disease is seen, it is repted as Gleason sce = 6.) In a radical prostatectomy, if a tertiary pattern is present, it is commented upon but not reflected in the Gleason sce. It is recommended that radical prostatectomy specimens should be processed in an ganized fashion where a determination can be made of a dominant nodule separate tum nodules. If a dominant nodule/s is present, the Gleason sce of this nodule should be separately mentioned as this nodule is often the focus with highest grade and/ stage of disease. Gleason X Gleason sce cannot be processed Gleason 6 Gleason 7 Gleason 8-10 Well differentiated (slight anaplasia) Moderately differentiated (moderate anaplasia) Poly differentiated/undifferentiated (marked anaplasia) Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The iginal and primary source f this infmation is the AJCC Cancer Staging Manual, Seventh Edition (2010), published by Springer Science+Business Media, LLC (SBM). (F complete infmation and data suppting the staging tables, visit Any citation quotation of this material must be credited to the AJCC as its primary source. The inclusion of this infmation herein does not authize any reuse further distribution without the expressed, written permission of Springer SBM, on behalf of the AJCC. ST-2

15 六 Updated Reference from NCCN V , difference as following: 1) Page2, 本 院 因 無 Brachytherapy, 故 對 於 Intermediate risk patient 的 治 療 無 此 選 擇, 和 NCCN V 包 含 Brachytherapy 不 同 2) Page3, 對 於 Initial-definitive therapy 後 的 surveillance, PSA 本 院 定 every 6 months follow 直 到 5 years 後 再 改 為 every year, 和 NCCN 6-12 months 不 同 3) Page3, N1 M1 的 PSA follow 定 為 every 6 months, 和 NCCN every 3-6 months 不 同 4) Page4, failure of PSA to fall 的 檢 查 去 除 ProstaScint 的 選 擇 5) Page 5, 本 院 因 無 Brachytherapy and Cryosurgery 故 將 選 項 取 消 ; 另 外 可 以 使 用 antiandrogen Reference from NCCN V ,difference as following: 1) Page 5, 因 本 院 新 引 進 Cryosurgery 設 備, 故 加 入 此 項 治 療 2) Page 6, Metastasis stage 加 入 Palliative Radiotherapy f local symptoms including bladder outlet obstruction, pending bowel obstruction, pending cd compression and pain control Reference from NCCN V , updated on100/2/17,difference as following: 1) Page5, Life expectancy< 10 y 加 入 Cryotherapy 2) Long-term cancer-specific and overall survival f men followed me than 10 years after primary and salvage cryoablation of the prostate Cheetham P, Truesdale M, Chaudhury S, Wenske S, Hruby GW, Katz A. J Endourol Jul;24(7): ) Page8-10, SALVAGE Distant 加 入 Hospice care Reference from NCCN V , updated on 101/7/12,difference as following: 1) Page5, Intermediate :Life expectancy< 10 y 刪 除 Radical prostatectomy + pelvic lymph node dissection 2) Page8, POST-RADICAL PROSTATECTOMY RECURRENCE Page9, POST-RADIATION THERAPY RECURRENCE 依 NCCN 修 改

16 Reference from NCCN V , updated on 102/2/07,difference as following: 1) Page6, high grade 增 列 Cryotherapy 2) Kristofer L.Prepelica,Zephaniah Okeke,Alana Murphy,Aaron E.Katz. (2005) cryosurgical ablation of the prostate :high -risk patient outcomes American Cancer Society. dio /cncr ) Page5, Low and Intermediate:Under expected patient survival ³10 y; radical prostatectomy with lymph node metastasis, added ADT + RT Reference from NCCN V , updated on 103/5/01,difference as following: 1) PROS-1:Very Low grade 增 列 20y->INITIAL THERAPY AND ADJUVANT THERAPY 2) PROS-3 4, Low and Intermediate:Under expected patient survival >10 y; radical prostatectomy with lymph node metastasis, added ADT ± RT 3) PROS-5 6,Initial management pathology, N1 M1, moniting; removed(including DRE). Post-RP recurrence, failure of PSA to fall to undetectable levels;added (PSA persistence). Post-RP recurrence, undetectable PSA after RP with a subsequent detectable PSA that increases on 2 me determinations; added(psa recurrence). Changed Post-radical prostatectomy recurrence to RadicalProstatectomy Biochemical Failure. 4) PROS-7: Changed Post-radiation therapy recurrence to Radiation Therapy Recurrence. Changed prostate biopsy to TRUS biopsy. Changed endectal MRI to prostate MRI. Added ± C-11 choline PET.( 本 院 無 此 檢 查 故 不 加 ) 5) PROS8~10: 增 列 ADVANCED DISEASE: SYSTEMIC THERAPY 並 把 本 院 沒 有 藥 物 的 項 目 刪 除