The document describes standardized outcome measures for localized prostate cancer developed with input from 300 experts globally. It includes measures for acute complications, survival rates, disease control, patient-reported health status, and hormonal therapy side effects. For patient-reported health status, it specifically describes the Expanded Prostate cancer Index Composite-26 (EPIC-26) questionnaire which measures quality of life across domains of urinary, bowel, and sexual function and hormonal therapy side effects.

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0 10 20 30 40 50 60 70 80
Salomon et al. 2003
Bianco et al.2005
Saranchuk et al.2005
Pierorazio et al.2007
Eastham et al. 2008
Shikanov et al. 2009
Ploussard et al. 2010
Xylinas et al. 2010
Percent of prostatectomy patients who are continent, potent and cancer-free 2 years aftersurgery
53%
54%
44%
62%
76%*
42%
60%
20%
Source: Xylinas et al., Urologic Oncology 31 (2013) Copyright © 2015 by ICHOM; All rights reserved
* low-risk group

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Australia 2
Canada 2
Europe 24
Israel 1
Taiwan 1
USA 18
EPAD 2015

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• University Hospitals Leuven
• Erasmus Medical Center Rotterdam
• Istituto Clinico Humanitas Milan
• NHS England
• The Scottish Government
• Great Ormond Street Hospital London
• St. Erik Eye Hospital Stockholm
• Ordem dos Enfermeiros Lisbon
• Macular Society UK
• Retina patient support oranization
Suisse
EPAD 2015
• Sahlgrenska Universitetssjukhuset Gothenburg
• Leiden University Cancer Center Leiden/Den Haag
• British Heart Foundation
• Stichting Benchmark GGZ Bilthofen
• NHS Camden
• CCG Hampstead
• Générale de Santé Paris
• Carl Bennet AB Gothenburg
• DICA Leiden
• Aneurin Bevan University Health Board Newport
• Santeon Eindhoven, Nijmwegen, Groningen,
Amsterdam
Europe

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With support from 300 experts from around the world standard sets
outcomes have been developed for 12 conditions
 Localized Prostate Cancer
 Advanced Prostate Cancer
 Coronary Artery Disease
 Low Back Pain
 Cataracts
 Parkinson‘s Disease
EPAD 2015
 Depression and Anxiety
 Cleft Lip and Palate
 Hip & Knee Osteoarthritis
 Lung Cancer
 Stroke
 Macular Degeneration

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For these 7 conditions standard sets are in progress
 Pregnancy and Childbirth
 Colorectal Cancer
 Breast Cancer
 Heart Failure
 Dementia
 Craniofacial Microsomia
 Primary and Preventive Care for older persons
EPAD 2015

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Measure Details Timing Data Source
Acute
Complications
(within 6
months of
treatment)
Surgery patients:
Clavien
Classification
Presence or absence of ≥
Grade III
At 6 months
after treatment
initiation
Clinical or
patient
reported
Radiation patients:
CTCAE
Classification
Presence or absence of ≥
Grade 3 including name of the
Adverse Event
Survival and
disease
control
Overall survival Date of death Evaluated at
least annually
until death
Administrative data
Cause-specific
survival
Was death attributed to
prostate cancer on death
certificate
Administrative data
Metastasis-free
survival
Indicated date of metastatic
disease if applicable and
whether it was diagnosed
clinically or radiographically
Clinical or patient
reported
Biochemical
recurrence-free
survival
Indicate date of PSA
recurrence21,22 if applicable
All PSAs and dates following
treatment should be recorded
Clinical or patient
reported

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Measure Details Timing Data Source
Patient-
reported
health status
Urinary
incontinence
domain scores
EPIC-26 urinary incontinence
domain
At baseline, 6
months after
treatment and
then annually
following
treatment until
10 years or the
diagnosis of
metastatic
disease
Patient reported
Urinary
irritative/obstructiv
e scores
EPIC-26 urinary
irritative/obstructive domain
Bowel symptom
scores
EPIC-26 bowel domain
Sexual symptom
scores
EPIC-26 sexual domain;
Question 50 from the EORTC
QLQ PR25 scale30; Outlined
in the text34
Hormonal
symptom scores
(for men receiving
androgen
deprivation
therapy)
EPIC-26 hormonal domain

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The questionnaire measures Quality of Life issues in patients with prostate
cancer. 13 questions (within past 4 weeks) about 4 domains:
EPAD 2015
 urinary function
leaking urine, urinary control. use of pads or adult diapers, pain
or burning on urination, bleeding with urination, weak urine
stream or incomplete emptying, need to urinate frequently during
the day

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 bowel habits
urgency to have a bowel movement, increased frequency of
bowel movements, losing control of your stools, bloody stools,
abdominal/ Pelvic/Rectal pain
EPAD 2015

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 ability to function sexually
usual QUALITY of erections, ability to have an erection, ability to
reach orgasm (climax), FREQUENCY of erections
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 hormonal therapy side effects
hot flashes, breast tenderness/enlargement, feeling depressed,
lack of energy, change in body weight
EPAD 2015