2010NCCN指南-前列腺癌检查

Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. Continue NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer Early Detection V.2.2010 www.nccn.org Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection NCCN Prostate Cancer Early Detection Panel Members Mark H. Kawachi, MD/Chair City of Hope Cancer Center Richard J. Babaian, MD The University of Texas M.D. Anderson Cancer Center Robert R. Bahnson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University Michael Barry, MD Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center J. Erik Busby, MD University of Alabama at Birmingham Comprehensive Cancer Center Peter R. Carroll, MD UCSF Comprehensive Cancer Center H. Ballentine Carter, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins William J. Catalona, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Michael S. Cookson, MD Vanderbilt-Ingram Cancer Center � � � � � � � Þ Jonathan I. Epstein, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Ruth B. Etzioni, PhD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Veda N. Giri, MD Fox Chase Cancer Center George P. Hemstreet, III, MD, PhD UNMC Eppley Cancer Center at The Nebraska Medical Center Richard J. Howe, PhD Consultant Paul H. Lange, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Hans Lilja, MD, PhD Memorial Sloan-Kettering Cancer Center Kevin R. Loughlin, MD Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center James Mohler, MD Roswell Park Cancer Institute � †† † † � � � ¥ Judd Moul, MD Duke Comprehensive Cancer Center Robert B. Nadler, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Stephen G. Patterson, MD H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida Joseph C. Presti, MD Stanford Comprehensive Cancer Center Antoinette M. Stroup, PhD & Huntsman Cancer Institute at the University of Utah Robert Wake, MD St. Jude’s Children’s Research Hospital/University of Tennessee Cancer Institute John T. Wei, MD, MS University of Michigan Comprehensive Cancer Center � � � � � † † Medical oncology § Radiotherapy/Radiation oncology * Writing committee member � Urology Þ Internal Medicine Pathology & Epidemiology †† Biostatistician � ¥ Patient advocacy Continue NCCN Guidelines Panel Disclosures Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection Table of Contents NCCN Prostate Cancer Early Detection Panel Members Summary of Guidelines Updates (UPDATES) Introduction (PROSD-1) Baseline Evaluation (PROSD-2) Diagnostic Evaluation, Screening Results (PROSD-3) DRE Positive (PROSD-4) DRE Negative, PSA Performed (PROSD-5) Screening Results; PSA 4-10 ng/mL (PROSD-6) Screening Results; PSA > 10 ng/mL (PROSD-7) Guidelines Index Print the Prostate Cancer Early Detection Guidelines TRUS-Guided Biopsy Results (PROSD-8) Talking Points About the Pros and Cons of PSA Testing (PROSD-A) These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2009. Clinical Trials: Categories of Evidence and Consensus: NCCN The believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. To find clinical trials online at NCCN member institutions, All recommendations are Category 2A unless otherwise specified. See NCCN click here: nccn.org/clinical_trials/physician.html NCCN Categories of Evidence and Consensus For help using these documents, please click here Discussion References Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. UPDATES Summary of changes in the 1.2010 version of the Prostate Cancer Early Detection Guidelines include: ) � � � � � The Guidelines are specifically for men opting to participate in an early detection program (after receiving the appropriate counseling on the pros and cons of early detection). Under Screening and Follow-Up, the PSA value was changed from 0.6 ng/mL to 1.0 ng/mL with the addition of a footnote. Footnote “e” states “The PSA value of 1.0 ng/mL selects for the upper range of PSA values for 40-49 year-old men.” Footnote “g” is new to the page. “Less frequent PSA/DRE follow-up in the older patient may be appropriate based on their individual risk stratification.” Level 1 evidence for PSA screening is now available through a European study released in 2009. The European Randomized Study of Screening for Prostate Cancer (ERSPC) was initiated in the early 1990's to evaluate the effect of prostate-specific antigen (PSA) testing on death rates from prostate cancer. The trial involved 182,000 men between the ages of 50 and 74 in 7 European countries, randomly assigned to a group that was offered PSA screening at an average of once every 4 years or to a control group that did not receive such screening. The predefined core group included 162,243 men of ages of 55-69 years. Death from prostate cancer was the primary outcome. During a median follow-up of 9 years, the cumulative incidence of prostate cancer was 8.2% in the screening group and 4.8% in the control group. There were 214 prostate cancer deaths in the screening group, and 326 in the control group. The rate ratio for death from prostate cancer in the screening group, compared to the control group, was 0.80 (95% confidence interval [CI], 0.65-0.98; adjusted P=0.04). The researchers concluded that PSA-based screening reduced the rate of death from prostate cancer by 20%. However, they also concluded that this was associated with a high risk of over-diagnosis. Statistically, 1,410 men would need to be screened and 48 men would need to be treated to prevent one death from prostate cancer Footnote “a” has been modified. “Screening in men over 75 y should be considered individually.” Previously recommended individualized screening in men over 80 y. PROSD-1 PROSD-2 PROSD-A (page 2 of 3 Summary of changes in the 2.2010 version of the Prostate Cancer Early Detection Guidelines include: The addition of the updated .Discussion section Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection It is neither the intent nor the suggestion of the panel that all men diagnosed with prostate cancer require treatment. It is inhe The guidelines are continuously in a state of evolution and the panel will incorporate changes based on new evidence and expert opinion and provide a rating of consensus with respect to each recommendation. rent that as we maximize the detection of early prostate cancer we will increase the detection of both non-aggressive (slow growing) and aggressive (faster growing) prostate cancers. The challenge is to identify the biology of the cancer that is detected and thus identify cancers that, if treated effectively, will result in a significant decrease in morbidity and mortality. This variability in prostate tumor behavior is unlike any other cancer and, consequently, causes major concern with the problem of over treatment resulting in potentially significant adverse implications on quality of life issues (eg, urinary, bowel and erectile dysfunction). The natural history of prostate cancer is that it will progress over time, but the unanswerable question is over what period of time. The Prostate Cancer Early Detection guidelines do not address the treatment of prostate cancer. The guidelines are specifically for men opting to participate in an early detection program (after receiving the appropriate counseling on the pros and cons). It is the majority opinion of the Prostate Cancer Early Detection panel members that there is a growing population of men currently being diagnosed with prostate cancer who can, and should, be monitored for their disease as presented in the Prostate Cancer Treatment Guidelines. The guidelines for a baseline PSA and lowering the PSA thresholds for biopsy were recommended by most panel members, but a consensus was not reached. See Suggested “talking points” to cover in a discussion with a potential screenee about the pros and cons of PSA testing (PROSD-A). INTRODUCTION PROSD-1 See Baseline Evaluation (PROSD-2)Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection Return to Prostate Cancer Early Detection Table of Contents PROSD-2 BASELINE EVALUATION SCREENING EVALUATION FOLLOW-UP Start risk and benefit discussion and Offer baseline DRE and PSA at age 40 (category 2B) PSA 1.0 ng/mL � e or African American or Family history PSA < 1.0 ng/mLe Repeat at age 45 PSA ng/mL� 1.0 PSA 1.0 ng/mL> Annual follow-up (category 2B): � � DRE PSA Annual follow-up (category 2B):f � � DRE PSA Offer regular screening at age 50g See Screening Results (PROSD-3) See Screening Results (PROSD-3) See Diagnostic Evaluation (PROSD-3) a c d e g Screening in men over 75 y should be considered individually. PSA Velocity: For men with PSA < 4 ng/mL, data suggest that a PSA velocity of 0.35 ng/mL/y is suspicious for the presence of cancer (Carter HB, Ferrucci L, Kettermann A at el. Detection of Life-Threatening Prostate Cancer With Prostate-Specific Antigen Velocity During a Window of Curability. J Natl Cancer Inst 2006;98(21):1521-1527); for men with PSA 4-10 ng/mL, a PSA velocity of 0.75 ng/mL/y is suspicious for cancer. PSA velocity in men with PSA > 10 ng/mL has not been determined useful. Measurement should be made on at least three consecutive specimens drawn over at least an 18-24 mo interval. There is variability. Longer time periods increase reliability, but, as calculation of PSA velocity over longer prior time intervals usually decreases the PSA velocity estimate, it might decrease predictive power. It is also important to remember that biologic variability and/or prostatitis may be confounding factors in determining PSA velocity; therefore, antibiotic therapy and repeated PSA measurements may be considered to minimize these sources of confusion. The PSA value of 1.0 ng/ml selects for the upper range of PSA values for 40-49 year-old men. There is no evidence in the literature to support the follow-up recommendations listed; they represent the consensus-based opinions of the panel based upon their clinical experience. Less frequent PSA/DRE follow-up in the older patient may be appropriate based on their individual risk stratification. bFamily history may affect a decision to biopsy. The closer the relative, the earlier the onset and the more affected family members, the higher the risk. � � f See Introduction (PROSD-1) RISK ASSESSMENTd �H&P including:a � � � � Family history Medications History of prostate disease and screening, including prior PSA and/or isoforms, exams and biopsies PSA velocity, if available b c Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. PSA 1.0 ng/mL� Repeat at age 45 PSA 1.0 ng/mL> Annual follow-up (category 2B): � � DRE PSA If PSA , offer screening at age 50 � 1.0 ng/mL g See Diagnostic Evaluation (PROSD-3) Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection PROSD-3 DIAGNOSTIC EVALUATION hIn patients using finasteride or dutasteride, failure to have a substantial decrease (approximately 50%) in PSA or an increase while on medication can be associated with an increased risk of prostate cancer. DRE Offer total PSA See Screening Results and Follow- up (PROSD-5) See Follow-up (PROSD-4) DRE positive regardless of PSA results TRUS-guided biopsy (See PROSD-8) SCREENING RESULTS FOLLOW-UP DRE negative PSA performed Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. PROSD-4 See NCCN Prostate Cancer Treatment Guidelines Benign See Screening Results (PROSD-5) FOLLOW-UP DRE positive Regardless of PSA result: Findings from TRUS-guided biopsy (See PROSD-8) hIn patients using finasteride or dutasteride, failure to have a substantial decrease (approximately 50%) in PSA or an increase while on medication can be associated with an increased risk of prostate cancer. Cancer Atypia, suspicious for cancer or High-grade PIN See Follow-up for TRUS- guided biopsy (PROSD-8) PSA � � � � � � h h Ejaculation: Results are more reliable if patient has abstained from ejaculation for 48 hr. If this condition is not met, repeat after 48 hr abstention, if the original sample was marginally elevated. Medicines that affect PSA: Finasteride Androgen receptor blockers Dutasteride Version 2.2010, 08/07/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN ® Practice Guidelines in Oncology – v.2.2010 Guidelines Index Prostate Early Detection TOC Discussion, ReferencesProstate Cancer Early Detection Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. PROSD-5 SCREENING RESULTS FOLLOW-UP DRE negative PSA performed PSA Velocity < ng/mL/y0.35 c Continue follow-up PSA Velocity ng/mL/y� 0.35 c Consider initial TRUS- guided biopsy (See PROSD-8) TRUS-guided biopsy performed (See PROSD-8) PSA 4-10 ng/mL PSA > 10 ng/mL See NCCN Prostate Cancer Treatment Guidelines Benign � � � PSA 2.6-4 ng/mL or PSA velocity 0.35 ng/mL/yc when PSA 2.5 ng/mL � � � PSA 2.5 ng/mL and PSA velocity < 0.35 ng/mL/y if available � See PSA 4 to 10 ng/mL (PROSD-6) See PSA > 10 ng/mL (PROSD-7) 6-12 mo follow-up with DRE Consider percent free PSA c cPSA Velocity: For men with PSA < 4 ng/mL, data suggest that a PSA velocity of 0.35 ng/mL/y is suspicious for the presence of cancer (Carter HB, Ferrucci L, Kettermann A at el. Detection of Life-Threatening Prostate Cancer With Prostate-Specific Antigen Velocity During a Window of Curability. J Natl Cancer Inst 2006;98(21):1521-1527) and biopsy is recommended; for men with PSA 4-10 ng/mL, a PSA velocity of 0.75 ng/mL/y is suspicious for cancer. PSA velocity in men with PSA > 10 ng/mL is not available. Measurement should be made on at least three consecutive specimens drawn over at least an 18-24 mo interval. There is variability. Longer time periods increase reliability, but, as calculation of PSA velocity over longer prior time intervals usually decreases the PSA velocity estimate, it might decrease predictive power. It is also important to remember that biologic variability and/or prostatitis may be confounding factors in determining PSA velocity; therefore, antibiotic therapy and repeated PSA measurements should be used to minimize these sources of confusion. Factors to consider: age (men over 75 y should be considered individually), comorbid conditions, percent free PSA, prostate exam/size, strength of family history, African American. � � j kFree PSA is not generally used in deciding whether or not to perform an initial biopsy. However, in selected circumstances, it may be considered employing the following recommendations: > 25%, no biopsy; 10% biopsy; > 10% 25% indeterminate, consider biopsy.� � Consider biopsyj TRUS-guided biopsy not performed Use of free PSA in considering initial biopsy: 10% Biopsy > 10 25% Consider biopsy > 25% Consider deferring biopsy k � � � � � Annual DRE and PSA Cancer Atypia, suspicious for cancer or High-grade PIN See Follow-up for TRUS- guided biopsy (PROSD-8) Version 2.2010, 08/07/09 © 2009 National