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NCCN Guidelines IndexTable of Contents

Discussion

Version 2.2012, 05/02/12 © National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN .®®

NCCN Guidelines Version 2.2012Prostate Cancer Early Detection

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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) ®

Prostate Cancer

Early DetectionVersion 2.2012

www.NCCN.org




Discussion



Joseph C. Presti, MD/Chair

Stanford Cancer Institute

Gerald Andriole, MDSiteman Cancer Center at Barnes-JewishHospital and Washington University Schoolof Medicine

Robert R. Bahnson, MD

The Ohio State University ComprehensiveCancer Center - James Cancer Hospital andSolove Research Institute

Daniel A. Barocas, MD, MPH Vanderbilt-Ingram Cancer Center

Michael Barry, MDMassachusetts General Hospital Cancer

Center

J. Erik Busby, MDUniversity of Alabama at BirminghamComprehensive Cancer Center

H. Ballentine Carter, MD

The Sidney Kimmel Comprehensive Cancer

Center at Johns Hopkins

William J. Catalona, MDRobert H. Lurie Comprehensive Cancer Center of Northwestern University

Þ

Peter R. Carroll, MDUCSF Helen Diller Family Comprehensive

Cancer Center

John W. Davis, MD

The University of Texas MD AndersonCancer Center

Jonathan I. Epstein, MDThe Sidney Kimmel ComprehensiveCancer Center at Johns Hopkins

Ruth B. Etzioni, PhDFred Hutchinson Cancer ResearchCenter/Seattle Cancer Care Alliance

Veda N. Giri, MDFox Chase Cancer Center

George P. Hemstreet, III, MD, PhDUNMC Eppley Cancer Center at TheNebraska Medical Center

Mark H. Kawachi, MDCity of Hope Comprehensive Cancer Center

Paul H. Lange, MDUniversity of Washington MedicalCenter/Seattle Cancer Care Alliance

Kevin R. Loughlin, MDDana-Farber/Brigham and Women’sCancer Center

&

†

James Mohler, MD

Roswell Park Cancer Institute

Judd Moul, MD

Duke Cancer Institute

Robert B. Nadler, MDRobert H. Lurie Comprehensive Cancer Center of Northwestern University

Antoinette M. Stroup, PhD &Huntsman Cancer Institute at the University of Utah

Andrew J. Vickers, PhDMemorial Sloan-kettering Cancer Center

Robert Wake, MDSt. Jude Children’s Research Hospital/Universityof Tennessee Cancer Institute

Jingsong Zhang, MD, PhDH. Lee Moffitt Cancer Center & ResearchInstitute

Maria Ho, PhDDorothy A. Shead, MS

††

NCCN Staff

† Medical oncology

§ Radiotherapy/Radiation oncology

* Writing committee member

Urology

Þ Internal Medicine

Pathology

& Epidemiology†† Biostatistician

¥ Patient advocacyContinue

NCCN Guidelines Panel Disclosures

Panel Members

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Discussion



It is neither the intent nor the suggestion of the panel that all men diagnosed with prostate cancer require treatment. It is inherent 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.

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.

See Talking Points About the Pros and Cons of PSA Testing (PROSD-A).

INTRODUCTION

PROSD-1

See Baseline Evaluation(PROSD-2)

Note: All recommendations are category 2Aunless 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.







Discussion



PROSD-3

EARLY DETECTION EVALUATION FOLLOW-UP

PSA 1.0 ng/mLe

or

African Americanor Family historyor Men taking 5- alpha-reductase

inhibitors (5ARI)

PSA <1.0 ng/mLe Repeat at age 45

PSA ng/mL1.0

PSA 1.0 ng/mL>Annual follow-up:

DRE

PSA

Annual follow-up : f

DRE

PSA

Offer early detection

testing at age 50g

See Early Detection

Results (PROSD-4)

See Early DetectionResults (PROSD-4)

See DiagnosticEvaluation

(PROSD-4)

e

g

The reported median PSA values for men age 40-49 y range from 0.5-0.7 ng/mL, and the 75th percentile values range from 0.7-0.9 ng/mL; therefore, the PSA value of 1.0 ng/mL selects for the upper range of PSA values. Men who have a PSA above the median for their age group are at a higher risk for prostate cancer and for theaggressive form of the disease, and the higher above the median, the greater the risk.

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.

f



PSA 1.0 ng/mLRepeat at

age 45

PSA 1.0 ng/mL>Annual follow-up:

DRE

PSA

If PSA ,

offer early detection

testing at age 50

1.0 ng/mL

g

See DiagnosticEvaluation(PROSD-4)


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Discussion



PROSD-4

DIAGNOSTIC EVALUATION

h

In patients using finasteride or dutasteride, failure to have a substantial decrease (approximately 50%) inPSA or an increase while on medication can be associated with an increased risk for prostate cancer.

DREOffer total PSAh

See Early Detection

Results and Follow-Up(PROSD-6)

See Follow-Up(PROSD-5)

DRE positive

regardless of

PSA results

Transrectal

ultrasound

(TRUS)-guided

biopsy

(See PROSD-5)

RESULTS FOLLOW-UP

DRE negative

PSA performed



PSA

Ejaculation:Results are more reliable if the patient

has abstained from ejaculation for 48 h.

If this condition is not met repeat after

48 h abstention, if the original sample

was marginally elevated.

Medicines that affect PSA:

Ketoconazole

5ARIsdutasteridefinasteride

h

h








Discussion





PROSD-5

Managementof biopsyresults

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 for prostate cancer.

Cancer See NCCN Prostate Cancer Treatment Guidelines

Atypia,

suspiciousfor cancer

Extended pattern rebiopsy (within 6 mo) with

increased sampling of the atypical small acinar

proliferation (ASAP) site and adjacent areas. If nocancer is found, close follow-up with PSA and DRE

is recommended

High-grade

prostatic

intraepithelial

neoplasia

(PIN)

Benign

Follow-up, based on DRE and PSA findings:

Positive DRE (See PROSD-4)

High Risk (See PROSD-5)

PSA 4-10 (See PROSD-7)

PSA > 10 (See PROSD-8)

TRUS-GUIDED BIOPSY

Initial and Repeat

Number of cores:Sextant (6) ,Lateral peripheral zone (6), andLesion-directed at palpable nodule or

suspicious imageAnteriorly directed biopsy is not supported in

routine biopsy. However, the addition of a

transition zone biopsy to an extended biopsyprotocol may be considered in a repeat

biopsy if PSA is persistently elevated.After 2 negative extended TRUS biopsies,

prostate cancer is not commonly found at

repeat biopsy. Additional MRI imaging (T2

plus diffusion weighting) may help identify

regions of cancer missed on prior biopsies

and should be considered in selected cases.

For high-risk men with multiple negativebiopsies, consideration can be given to a

saturation biopsy strategy.Local anesthesia can decrease

pain/discomfort associated with prostate

biopsy.

Extended-pattern biopsy (12 cores)

If initial sextant biopsy used,

rebiopsy using extended pattern

Repeat biopsy within the first

year, if high-grade PIN is

multi-focal ( 2 cores)

If no cancer is

found, close

follow-up with

PSA and DRE is

recommended

MANAGEMENT OF BIOPSY RESULTS

y y p y pp py g p , , g


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Discussion





PROSD-8

Biopsy

Benign Negative

Re-evaluate with PSAand DRE

Consider rebiopsy

timing interval 3-

to12-mo based on

doctor-patient

discussion

Positive

See NCCN Prostate Cancer Treatment Guidelines

See NCCN Prostate

Cancer TreatmentGuidelines

PSA >10 ng/mL

EARLY DETECTION RESULTS FOLLOW-UP

Cancer

Atypia,

suspicious

for cancer or

high-grade

PIN

See TRUS-guided biopsy (PROSD-5)

6- to 12-mo follow-up withDRE, and total or percent-free PSA including PSAV;c

Consider a third biopsybased on individual patientparameters and choice

cPSA velocity: For men with a PSA <4 ng/mL, data suggest that a continuously increasing PSA velocity ( 0.35 ng/mL/y) is suspicious for the possible presence of life-threatening cancer (Carter HB, Ferrucci L, Kettermann A et al. Detection of Life-Threatening Prostate Cancer With Prostate-Specific Antigen Velocity During a Window

of Curability. 2006;98(21):1521-1527) and a biopsy should be considered; for men with a PSA 4-10 ng/mL, a PSA velocity of 0.75 ng/mL/y issuspicious for cancer. PSA velocity in men with a PSA >10 ng/mL is not useful. Measurement should be made on at least three consecutive specimens drawn over atleast an 18- to 24- mo interval. There is some variability between different laboratories and different assays. Longer time periods increase reliability, but, as calculationof PSA velocity over longer prior time intervals usually decreases the PSA velocity estimate, it might decrease predictive power. It is also important to remember thatbiologic variability and/or prostatitis may be confounding factors in determining PSA velocity; therefore, an abnormal PSA should be repeated and a course of antibiotic

may be considered to minimize these sources of confusion.

J Natl Cancer Inst.

Biopsy

not done

Repeat PSA and DRE

in 6-12 mo











NCCN Guidelines IndexProstate Early Detection TOC

NCCN Guidelines Version 2.2012P t t C E l D t ti






Version 2.2012, 05/02/12 © National Comprehensive Cancer Network, Inc. 2012, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any for m without the express written permission of NCCN®. REF-8

Prostate Early Detection TOCDiscussionProstate Cancer Early Detection

intraepithelial neoplasia is associated with high likelihood of prostate

cancer, independent of change in prostate specific antigen levels. JUrol 2002;168:1415-1418. Available at:http://www.ncbi.nlm.nih.gov/pubmed/12352407 .

104. Chan TY, Epstein JI. Follow-up of atypical prostate needlebiopsies suspicious for cancer. Urology 1999;53:351-355. Available at:http://www.ncbi.nlm.nih.gov/pubmed/9933053 .

105. Mian BM, Naya Y, Okihara K, et al. Predictors of cancer in repeat

extended multisite prostate biopsy in men with previous negativeextended multisite biopsy. Urology 2002;60:836-840. Available at:http://www.ncbi.nlm.nih.gov/pubmed/12429311 .

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