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NCCN Guidelines IndexProstate Table of Contents

Discussion

NCCN.org

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NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline ) ®

Prostate Cancer

Version 1.2012





Discussion

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James L. Mohler, MD/Chair

Roswell Park Cancer Institute

The Ohio State University ComprehensiveCancer Center - James Cancer Hospitaland Solove Research Institute

Barry Boston, MDSt. Jude Children’s Research Hospital/University of Tennessee Cancer Institute

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

Anthony Victor D’Amico, MD, PhD

Dana-Farber/Brigham and Women'sCancer Center | Massachusetts GeneralHospital Cancer Center

James A. Eastham, MDMemorial Sloan-Kettering Cancer Center

Charles A. Enke, MDUNMC Eppley Cancer Center

at The Nebraska Medical Center

Thomas FarringtonPatient Advocate

Celestia S. Higano, MDFred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

Eric Mark Horwitz, MD

Fox Chase Cancer Center

Andrew J. Armstrong, MD ScMDuke Comprehensive Cancer Center

Robert R. Bahnson, MD

†

†

†

£

§

§

§

Mack Roach, III, MD

UCSF Helen Diller FamilyComprehensive Cancer Center

Eric Rohren, MD, PhDThe University of TexasMD Anderson Cancer Center

Stan RosenfeldUniversity of California San FranciscoPatient Services Committee Chair

Sandy Srinivas, MDStanford Comprehensive Cancer Center

Seth A. Strope, MD, MPHSiteman Cancer Center at Barnes-Jewish Hospital and WashingtonUniversity School of Medicine

Jonathan Tward, MD PhDHuntsman Cancer Instituteat the University of Utah

Przemyslaw Twardowski, MDCity of Hope Comprehensive Cancer Center

Patrick C. Walsh, MDThe Sidney Kimmel ComprehensiveCancer Center at Johns Hopkins

§

§

†

†

Philip W. Kantoff, MD

Dana-Farber/Brigham and Women'sCancer Center | Massachusetts GeneralHospital Cancer Center

Mark H. Kawachi, MDCity of Hope ComprehensiveCancer Center

Michael Kuettel, MD, MBA, PhD

Roswell Park Cancer Institute

Richard J. Lee, MDDana-Farber/Brigham and Women'sCancer Center | Massachusetts GeneralHospital Cancer Center

Gary R. MacVicar, MDRobert H. Lurie Comprehensive Cancer Center of Northwestern University

Arnold W. Malcolm, MD, FACR Vanderbilt-Ingram Cancer Center

David Miller, MD, MPHUniversity of MichiganComprehensive Cancer Center

Elizabeth R. Plimack, MD, MS

Fox Chase Cancer Center

Julio M. Pow-Sang, MDH. Lee Moffitt Cancer Center &Research Institute

†

†

†

†

§

§

§ Radiotherapy/Radiation oncology

Urology

Medical oncology£ Supportive Care including Palliative, Pain management,Pastoral care and Oncology social work

†

*Writing committee member NCCN Guidelines Panel Disclosure

NCCNMaria Ho, PhDDorothy A. Shead, MS

NCCN Guideline Version 1.2012 Panel MembersProstate Cancer

*

*

*

*

*

*

*

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Discussion

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 or warranties of any kind,

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. ©2012.

NCCN Prostate Cancer Panel Members

Summary of Guideline Updates

Initial Prostate Cancer Diagnosis, Staging Workup, Recurrence Risk (PROS-1)

Very Low-Risk, Low-Risk: Initial Therapy, Adjuvant Therapy (PROS-2)

Monitoring (PROS-5)

Post-Radical Prostatectomy Recurrence: Workup and Primary Therapy (PROS-6)

Post-Radiation Therapy Recurrence: Workup and Primary Therapy (PROS-7)

Advanced Disease: Systemic Therapy (PROS-8)

Advanced Disease: Additional

Principles of Life Expectancy Estimation (PROS-A)

Principles of Active Surveillance (PROS-B)

Principles of Radiation Therapy (PROS-C)

Principles of Surgery (PROS-D)

Principles of (PROS-E)

Principles of Chemotherapy/Immunotherapy (PROS-F)

Staging (ST-1)

Intermediate-Risk: Initial Therapy, Adjuvant Therapy (PROS-3)

High-Risk, Locally Advanced, and Metastatic (PROS-4)

Systemic Therapy for Castration-Recurrent Prostate Cancer (PROS-9)

Androgen Deprivation Therapy

Clinical Trials:

Categories of Evidence andConsensus:NCCN

Thebelieves that the best managementfor any cancer patient is in a clinicaltrial. Participation in clinical trials isespecially encouraged.

To find clinical trials online at NCCNmember institutions,

All recommendationsare Category 2A unless otherwisespecified.

See

NCCN

click here:nccn.org/clinical_trials/physician.html

NCCN Categories of Evidenceand Consensus

NCCN Guideline Version 1.2012 Table of ContentsProstate Cancer



http://www.nccn.org/clinical_trials/physician.html












Discussion

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.

Preferred treatment for any therapyis approved clinical trial.

INITIAL PROSTATE

CANCER DIAGNOSIS

INITIAL CLINICAL

ASSESSMENT

STAGING WORKUP

( )7th Edition of the AJCC Staging Manual

RECURRENCE RISK

DREPSAGleasonprimary andsecondarygrade

Life expectancy5 y and

asymptomatic

a

Life expectancy>5 y or symptomatic

a

No further workup or treatment untilsymptoms except for high-risk patient b

Bone scan if T1 andPSA >20 or T2 andPSA >10 or Gleason score 8or

T3, T4 or symptomatic

Pelvic CT or MRI if T3,T4 or T1-T2 andnomogram indicatedprobability of lymphnode involvement >20%

Suspiciousnodes

Consider biopsy

Intermediate:

c

T2b-T2c or

Gleason score 7 or

PSA 10-20 ng/mL

High:c

T3a or

Gleason score 8-10 or

PSA >20 ng/mL

See InitialTherapy

(PROS-2)

See InitialTherapy(PROS-4)

a

bIn selected patients where complications such as hydronephrosis or metastasis can be expected within 5 y,androgen deprivation therapy (ADT) or radiation therapy (RT) may be considered. High risk factors includebulky T3-T4 disease or Gleason score 8-10.

c

Patients with multiple adverse factors may be shifted into the next higher risk group.

See Principles of Life Expectancy (PROS-A).

PROS-1

All others; noadditional imaging

Very low:

T1c

Gleason score 6

PSA <10 ng/mL

Fewer than 3 prostate

biopsy cores positive,

50% cancer in each

corePSA density

<0.15 ng/mL/g

Low:

T1-T2a

Gleason score 2-6

PSA <10 ng/mL

Very high:T3b-T4

Metastatic:Any T, N1Any T, Any N, M1

See InitialTherapy(PROS-3)

Clinically Localized:

Locally Advanced:

NCCN Guidelines Version 1.2012Prostate Cancer


P i t d b Al d Bi ti 3/9/2012 6 03 24 AM F l l N t d f di t ib ti C i ht © 2012 N ti l C h i C N t k I All Ri ht R d







Discussion



RECURRENCE RISK EXPECTED

PATIENTSURVIVALa

<10 yd

10 y

INITIAL THERAPY

Active surveillancee

PSA at least as often as every 6 moDRE at least as often as every 12 moRepeat prostate biopsy as often as every 12 mo


PSA at least as often as every 6 moDRE at least as often as every 12 mo

Radical prostatectomy± pelvic lymph node dissection if predictedprobability of lymph node metastasis 2%

g

a

d

e

The Panel remains concerned about the problems of over-treatment related tothe increased diagnosis of early prostate cancer from PSA testing.

. Active surveillance isrecommended for these subsets of patients.

Active surveillance involves actively monitoring the course of disease with theexpectation to intervene if the cancer progresses

.

See Principles of Life Expectancy (PROS-A).

See Principles of Active

Surveillance (PROS-B)

See NCCNGuidelines for Prostate Cancer Early Detection

PROS-2


f

g

h

i

j

.

.

Criteria for progression are not well defined and require physician judgement;however, a change in risk group strongly implies disease progression.

Adverse laboratory/pathologic features include: positive margins, seminal vesicleinvasion, extracapsular extension or detectable PSA.

See Principles of Radiation Therapy (PROS-C

See Principles of Surgery (PROS-D

See Principles of Androgen Deprivation Therapy (PROS-E

)

)

).

Progressive diseaseh

See Initial ClinicalAssessment (PROS-1)

Adverse features:RT

Observation

i

f

or

Lymph node metastasis:Observationor Androgen deprivation therapy j

SeeMonitoring(PROS-5)

RT (3D-CRT/IMRT with dailyIGRT or brachytherapy)

f

Very Low:

T1c

Gleason score 6

PSA <10 ng/mL

Fewer than 3 prostate

biopsy cores positive,

50% cancer in any

corePSA density

<0.15 ng/mL/g

Low:

T1-T2a

Gleason score 6

PSA <10 ng/mL

<20 yd

Active surveillance (category 2B)e

PSA at least as often as every 6 moDRE at least as often as every 12 moRepeat prostate biopsy as often as every 12 mo

20 y See Initial Therapy for Low recurrence risk below


ADJUVANT THERAPY


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Discussion

<10 y

10 yk

RT 3D-CRT/IMRT with daily IGRT)± short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo)± brachytherapy)

f

(

Radical prostatectomy + pelvic

lymph node dissection if predictedprobability of lymph nodemetastasis 2%

g

RT 3D-CRT/IMRT with daily IGRT)± short-term neoadjuvant/concomitant/adjuvant ADT (4-6 mo)

± brachytherapy

f (

RECURRENCE RISK EXPECTED

PATIENTSURVIVALa

INITIAL THERAPY


Progressive diseaseh

See Initial Clinical Assessment (PROS-1)

Adverse features:RTor Observation

i

f

Lymph node metastasis:Observationor Androgen deprivation therapy j

See(PROS-6)

a

c

ePatients with multiple adverse factors may be shifted into the next higher risk group.

Active surveillance involves actively monitoring the course of disease with the expectationto intervene if the cancer progresses. .

f

g

h

.

.

Criteria for progression are not well defined and require physician judgement; however, a

change in risk group strongly implies disease progression.

See Principles of Life Expectancy (PROS-A



).

)

)

See Principles of Active Surveillance (PROS-B)

i

j

Adverse laboratory/pathologic features include: positive margins, seminalvesicle invasion, extracapsular extension or detectable PSA.

k Active surveillance of intermediate and high risk clinically localizedcancers is not recommended in patients with life expectancy > 10 years

(category 1).

See Principles of Androgen Deprivation Therapy (PROS-E).

PROS-3



Intermediate:c

T2b-T2c or

Gleason score 7 or

PSA 10-20 ng/mL


PSA as often as every 6 moDRE as often every 12 mo


Undetectable

PSA

Detectable

PSA

SeeMonitoring(PROS-5)

ADJUVANT THERAPY


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Discussion

Very High:T3b-T4

Any T, N1

Any T,Any N, M1

RECURRENCE RISK INITIAL THERAPY ADJUVANT THERAPY

RT (3D-CRT/IMRT with daily IGRT) + long-termneoadjuvant/concomitant/adjuvant ADT (2-3 y)(category 1)

or

Radical prostatectomy + pelvic lymph nodedissection (selected patients with no fixation)

f

j

g

or RT (3D-CRT/IMRT with daily IGRT) +brachytherapy ± short-termneoadjuvant/concomitant/adjuvant ADT (4-6 mo)

f

RT (3D-CRT/IMRT with RT) + long-termneoadjuvant/concomitant/adjuvant ADT (2-3y)(category 1)or

Radical prostatectomy + pelvic lymph nodedissection (selected patients: with no fixation)or ADT

f

j

g

j l

RT (3D-CRT/IMRT with daily IGRT) +

brachytherapy ± short-termneoadjuvant/concomitant/adjuvant ADT (4-6 mo)or

in select patients

f

daily IG

ADT j

or RT f (3D-CRT/IMRT with T) + long-term

neoadjuvant/concomitant/adjuvant ADT (2-3y) j

(category 1)

daily IGR

ADT j

See

Monitoring

(PROS-5)

Undetectable

PSA

Detectable

PSA

See Post-RadicalProstatectomyRecurrence(PROS-6)

PROS-4

cPatients with multiple adverse factors may be shifted into the next higher risk group.

.

.

f

gSee Principles of Radiation Therapy (PROS-C


)

)



Locally Advanced:

Metastatic:

See Monitoring (PROS-5)



jLymph node metastasis:ADT

or Observation

High:c

T3a or

Gleason

score 8-10 or

PSA >20

ng/mL

i

j

l

Adverse laboratory/pathologic features include: positive margins, seminalvesicle invasion, extracapsular extension or detectable PSA.

Primary therapy with ADT should be considered only for patients who are not

candidates for definitive therapy.

See Principles of Androgen Deprivation Therapy (PROS-E).


Adverse features:i

RTor Observation

f

jLymph node metastasis:ADT

or Observation

Adverse features:i

RTor

Observation

f


SeeMonitoring

(PROS-5)

UndetectablePSA

Detectable

PSA











Discussion



MONITORING

Initial-definitive therapy

N1 or M1

PSA every 6-12 mo for 5 y,then every year DRE every year, but maybe omitted if PSAundetectable

Physical exam (including

DRE) + PSA every 3-6 mo

RECURRENCE

Post-radicalprostatectomy

Post-RT

Advanced disease

Failure of PSA to fall toundetectable levels

Detectable PSA that increaseson 2 subsequent measurements

Rising PSAor Positive DRE

m

See Advanced DiseasePROS-8( ) and ( )PROS-9

RTOG-ASTRO (Radiation Therapy Oncology Group - American Society for Therapeutic Radiology and Oncology) Phoenix Consensus - (1) PSA rise by 2 ng/ml or moreabove the nadir PSA is the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure is determined "at call" (not backdated). Theyrecommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (with no hormonal therapy) with strict adherence to guidelines asto "adequate follow-up" to avoid the artifacts resulting from short follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited.

Retaining a strict version of the ASTRO definition allows comparison with a large existing body of literature.

m

INITIAL MANAGEMENT

OR PATHOLOGY

See Post-RadiationTherapy RecurrencePROS-7( )

PROS-5



y p y pp py g p , , g








Discussion



Failure of PSAto fall toundetectable

PSA detectableand rising on 2

or moresubsequentdeterminations

± Bone scan± CT/MRI± PSADT± Prostatebed biopsy

POST-RADICAL PROSTATECTOMY RECURRENCE

f

j.

.



)

)

PROS-6

Studies positive

for distant

metastases

RTADT

f j

± neoadjuvant/concomitant/adjuvantor Observation

ADT ± RT to site of metastases,

if in weight-bearing bones, or

symptomaticor Observation

j

f

Studies n

for distant

metastases

egative

Progression


See Advanced DiseasePROS-8( ) and ( )PROS-9








Discussion

Progression



Observationor Radicalprostatectomyor Cryosurgeryor Brachytherapy

g

f

Post-RTrising PSAor Positive DRE

l

Prostate biopsyBone scan± Abd/pelvic CT/MRI± Endorectal MRI± PSADT

Candidate for local

therapy:

Original clinical stage

T1-T2, NX or N0

Life expectancy >10 y

PSA now <10 ng/mL

Not a candidate

for local therapy

or ADT

Observation

j

Prostate biopsy

positive,

studies

for distant

metastases

negative

Studies positive

for distant

metastases

f

g

j

.

.

.

RTOG-ASTRO Phoenix Consensus - (1) PSA rise by 2 ng/ml or more above the nadir PSA is the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure is determined "at call" (not backdated).They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (with no hormonal therapy) with strict adherence toguidelines as to "adequate follow-up" to avoid the artifacts resulting from short follow-up. For example, if the median follow-up is 5 years, control rates at 3 yearsshould be cited. Retaining a strict version of the ASTRO definition allows comparison with a large existing body of literature.

m (Radiation Therapy Oncology Group - American Society for Therapeutic Radiology and Oncology)




)

)

)

PROS-7

Prostate biopsy

negative,

studies

for distant

metastases

negative

Observationor ADTor Clinical trialor More aggressive

work-up for local

recurrence(eg, repeat biopsy,

MR spectroscopy,

endorectal MRI)

j

POST-RADIATION THERAPY RECURRENCE


See AdvancedDiseasePROS-8( )

and( )PROS-9








Discussion

ADT naive(M0 or M1)

Relapsen

Relapsen

Relapsen

Orchiectomy

or

LHRH agonistalone ±antiandrogen7 d to preventtestosteroneflare

or

LHRH agonist+ antiandrogen

or

LHRHantagonist

Consider biopsyif small cellsuspected

Cisplatin/etoposideor

Carboplatin/etoposideor Docetaxel-based regimen

o,p

o,p

o,p

Small cell

Not small cell

n Assure castrate level of testosterone.o

pSee Principles of Chemotherapy/Immunotherapy (PROS-F).

See NCCN Guidelines for Small Cell Lung Cancer.

PROS-8

Studies

negative for

distantmetastases

Studies

positive for

distant

metastases

See Additional Systemic Therapy for

(PROS-9)Castration-Recurrent Prostate Cancer

See Additional

Systemic Therapy for

(PROS-9)

Castration-RecurrentProstate Cancer



ADVANCED DISEASE: SYSTEMIC THERAPY


Relapsen



http://sclc.pdf/

http://sclc.pdf/






Discussion

Symptomatic

Yes

No

Docetaxel (category 1)

Mitoxantrone

Palliative RT or radionucleide

for symptomatic bone

metastases

o

o,r

Clinical trial

Abiraterone acetate

(category 2B)

j,r

Sipuleucel-T (category 1)

Steroids

q

Secondary hormoneAntiandrogenAntiandrogen withdrawalKetoconazole or abiraterone acetate (category 2B)

DES or other estrogen

Docetaxel

Clinical trial

therapy

j

s

Studies

positivefor

metastases

Maintain castrate

serum levels of

testosteroneand

Denosumab

(category 1) or

zoledronic acid

(category 1) if

bone metastases

Abiraterone acetate

(category 1, post-docetaxel therapy )

Cabazitaxel (category 1, post-docetaxel)Salvage chemotherapy

Docetaxel rechallenge

Mitoxantrone

Other secondary hormone therapyAntiandrogen

Clinical trial

j

o

o

o

q

Antiandrogen withdrawalKetoconazole

SteroidsDES or other estrogen

Sipuleucel-T

Clinical trial (preferred)Observation

Secondary hormoneAntiandrogenAntiandrogen withdrawalKetoconazoleSteroidsDES or other estrogen

therapy

Studies

negative for

metastases

ADVANCED DISEASE: ADDITIONAL SYSTEMIC THERAPY FOR CASTRATION-RECURRENT PROSTATE CANCER (CRPC)

PSA relapse or

metastases (M1)

Follow

pathway below

j

q

o .

Sipuleucel-T is appropriate for asymptomatic or minimallysymptomatic patients with ECOG performance status 0-1.Sipuleucel-T islife expectancy <6 months.

r ocetaxel-based regimens.


See Principles of Chemotherapy/Immunotherapy (PROS-F)

).

not indicated in patients with hepatic metastases or

For patients who are not candidates for d



PROS-9

Maintain castrate

serum levels of

testosterone


s Although most patients without symptoms are not interested in chemotherapy, thesurvival benefit reported for docetaxel applies to those with or without symptoms.D patients with signs of rapid progression or hepatic

metastases despite lack of symptoms.

ocetaxel may be considered for



















http://nextpage/




http://nextpage/






Discussion

Monitor/SurveillanceADT has a variety of adverse effects including hot flashes, hot flushes, vasomotor instability, osteoporosis, greater incidence of clinical

fractures, obesity, insulin resistance, alterations in lipids, and greater risk for diabetes and cardiovascular disease. Patients and their

medical providers should be advised about these risks prior to treatment.

Screening and treatment for osteoporosis are advised according to guidelines for the general population from the National Osteoporosis

Foundation (www.nof.org). The National Osteoporosis Foundation guidelines include recommendations for (1) supplemental calcium (1200

mg daily) and vitamin D3 (800-1000 IU daily) for all men over age 50 y and (2) additional treatment for men when the 10 y probability of hip

fracture is 3% or the 10 y probability of a major osteoporosis-related fracture is 20%. Fracture risk can be assessed using the recently

released algorithm called FRAX® by the World Health Organization (www.shef.ac.uk/FRAX/index.htm). ADT should be considered “secondary

osteoporosis” using the FRAX® algorithm.

Denosumab (120 mg SQ monthly), zoledronic acid (4 mg IV annually) and alendronate (70 mg PO weekly) increase bone mineral density, a

surrogate for fracture risk, during ADT for prostate cancer. Treatment with either denosumab, zoledronic acid or alendronate sodium is

recommended when the absolute fracture risk warrants drug therapy.

Screening for and intervention to prevent/treat diabetes and cardiovascular disease are recommended in men receiving ADT. These medical

conditions are common in older men and it remains uncertain whether strategies for screening, prevention, and treatment of diabetes and

cardiovascular disease in men receiving ADT should differ from the general population.



PROS-E3 of 3

PRINCIPLES OF ANDROGEN DEPRIVATION THERAPY (page 3 of 3)






































































































Discussion







Version 1.2012, 02/22/12 © National Comprehensive Cancer Network, Inc. 2012, All rights reserved. The NCCN Guidelines® and this illustr ation may not be reproduced in any for m without the express written permission of NCCN®. MS-26

o

all men with metastatic CRPC, given the limited improvements in

outcomes seen with approved systemic options.

The decision to initiate therapy with abiraterone acetate with

prednisone or cabazitaxel with prednisone in the post-docetaxel CRPC

setting should be based on the available high-level evidence of safety,

efficacy, and tolerability of these agents and the application of this

evidence to an individual patient. There are no randomized trials

comparing these two agents, and there are currently no predictive

models or biomarkers that are able to identify patients who are likely to

benefit from either approach. Choice of therapy is based largely on

clinical considerations which include patient preferences. The NCCN

recommends that patients be monitored closely with radiologic imaging

(CT, bone scan), PSA tests, and clinical exams for evidence of

progression. In cases where PSA or bone scan changes may indicate

flare rather than true clinical progression, therapy should be continued

until clinical progression or intolerability.223 The sequential use of these

agents is reasonable in a patient who remains a candidate for further

systemic therapy.

Summary

The intention of these guidelines is to provide a framework on which to

base treatment decisions. Prostate cancer is a complex disease, with

many controversial aspects of management and with a dearth of sound

data to support treatment recommendations. Several variables

(including life expectancy, disease characteristics, predicted outcomes,

and patient preferences) must be considered by the patient and

physician in tailoring prostate cancer therapy to the individual patient.


Discussion







Version 1.2012, 02/22/12 © National Comprehensive Cancer Network, Inc. 2012, All rights reserved. The NCCN Guidelines® and this illustr ation may not be reproduced in any for m without the express written permission of NCCN®. MS-27

Table 1. Act ive surveillance experience in North America

Center Toronto55 Johns

Hopkins51, 56, 57

UCSF54

No. patients 450 769 531

Age (yr) 70 66 63

Follow-up (mo) 82 36 43

Overall survival 68% 98% 98%

CSS 97% 100% 100%Treatment 30% 33% 24%

Reason for reclassification

Grade change 8% 14% 38%

PSA increase 14%* - 26%†

Positive node 1% - -

Anxiety 3% 9% 8%

CSS = cancer-specific survival* PSA doubling time < 3 years†PSA velocity >0.75 ng/mL/y















































Discussion


d d f t t t N E l J M d 2004 351 1513

S l i R Cli C R 2011 A il bl t






Version 1.2012, 02/22/12 © National Comprehensive Cancer Network, Inc. 2012, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express writ ten permission of NCCN®.REF-16

advanced refractory prostate cancer. N Engl J Med 2004;351:1513-1520. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15470214.

217. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisoneor mitoxantrone plus prednisone for advanced prostate cancer. N EnglJ Med 2004;351:1502-1512. Available at:http://www.ncbi.nlm.nih.gov/pubmed/15470213.

218. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisoneor mitoxantrone plus prednisone for advanced prostate cancer: updated

survival in the TAX 327 study. J Clin Oncol 2008;26:242-245. Availableat: http://www.ncbi.nlm.nih.gov/pubmed/18182665.

219. Machiels JP, Mazzeo F, Clausse M, et al. Prospective randomizedstudy comparing docetaxel, estramustine, and prednisone withdocetaxel and prednisone in metastatic hormone-refractory prostatecancer. J Clin Oncol 2008;26:5261-5268. Available at:http://www.ncbi.nlm.nih.gov/pubmed/18794543.

220. Attard G, Reid AH, A'Hern R, et al. Selective inhibition of CYP17with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol 2009;27:3742-3748. Availableat: http://www.ncbi.nlm.nih.gov/pubmed/19470933.

221. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone andincreased survival in metastatic prostate cancer. N Engl J Med2011;364:1995-2005. Available at:http://www.ncbi.nlm.nih.gov/pubmed/21612468.

222. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone pluscabazitaxel or mitoxantrone for metastatic castration-resistant prostatecancer progressing after docetaxel treatment: a randomised open-labeltrial. Lancet 2010;376:1147-1154. Available at:http://www.ncbi.nlm.nih.gov/pubmed/20888992.

223. Ryan CJ, Shah SK, Efstathiou E, et al. Phase II Study of Abiraterone Acetate in Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer Displaying Bone Flare Discordant With

Serologic Response. Clin Cancer Res 2011. Available at:http://www.ncbi.nlm.nih.gov/pubmed/21632851.

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