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. 2020 Apr 25;9(12):4039–4058. doi: 10.1002/cam4.3018

TABLE 2.

Patient‐Reported Outcomes (PROs) and PRO measurements (PROMs) in the high‐quality PRO RCTs for prostate cancer

Name of study First author PCa risk category PRO PROM
PREVAIL, 2015 Loriot 27 mCRPC

HRQoL

Pain

FACT‐P

EQ‐5D

Brief Pain Inventory Short

PREVAIL, 2014 a Beer 28 mCRPC QoL FACT‐P
PREVAIL, 2017 Devlin 29 mCRPC HRQoL EQ‐5D
REACTT, 2015 Patel 30 Nonmetastatic PCa (GS ≤ 7, PSA < 10)

Erectile function

Patients’ treatment satisfaction

Self‐esteem (baseline)

Prostate‐specific QoL

IIEF‐EF

EDITS questionnaire

SEAR questionnaire

EPIC‐26

REACTT, 2013 Montorsi 31 Nonmetastatic PCa (GS ≤ 7, PSA < 10)

Erectile Function

Sexual encounter

IIEF‐EF score

SEP‐1/ SEP‐2 questions

RTOG‐0126, 2015 Bruner 32 cT1b‐2b, (+GS2‐6, PSA10‐20 OR GS7, PSA < 15)

Bladder function

Bowel function

Erectile function

FACE questionnaire

FACE questionnaire

IIEF questionnaire

RTOG‐0126, 2013 Michalski 33 cT1b‐2b, (+GS2‐6, PSA10‐20 OR GS7, PSA < 15)

Acute GI/GU toxicity

Late GI/GU toxicity

RTOG/EORTC late morbidity scoring system
RTOG‐0126, 2018 a Michalski 34 cT1b‐2b, (+GS2‐6, PSA10‐20 OR GS7, PSA < 15) / /
AFFIRM, 2014 Fizazi 35 mCRCP

Pain

HRQoL improvement

HRQoL deterioration

BPI‐SF

FACT‐P

FACT‐P

AFFIRM, 2015 Cella 36 mCRPC HRQoL FACT‐P
AFFIRM, 2012 a Scher 37 mCRPC QoL FACT‐P
AFFIRM, 2017 Armstrong 38 mCRPC / /
COU‐AA‐302 phase 3, 2013 Basch 39 mCRPC

Pain

HRQoL

BPI‐SF questionnaire

FACT‐P questionnaire

COU‐AA‐302 phase 3, 2012 a Ryan 40 mCRPC

HRQoL

Pain

FACT‐P

BPI‐SF

PROTECT, 2013 Beer 41 Nonmetastatic androgen dependent PCa with PSA relapse and GS ≥ 7 after RP QoL

BFI score

LASA score, GRoC scale, symptoms checklist

PROTECT, 2011 Beer 42 Nonmetastatic androgen dependent PCa with PSA relapse and GS ≥ 7 after RP / /
SWOG‐9346, 2013 a Hussain 43 mCRPC HRQoL QoL questionnaire (SWOG)
NR Mason 44 T2b‐T4N0M0, GS ≥ 7, or PSA ≥ 10

LUTS relief

QoL (urinary symptoms)

IPSS
TROG 03.04 RADAR, 2012 Denham 18 cT2b–4N0M0 or T2a + GS≥7 + PSA≥10 QoL EORTC QLQ‐C30 + EORTC QLQ‐PR‐25 questionnaires
TROG 03.04 RADAR, 2014 Denham 45 cT2b–4N0M0 or T2a + GS≥7 + PSA≥10 / /
TROG 03.04 RADAR, 2012 Denham 46 cT2b–4N0M0 or T2a + GS≥7 + PSA≥10 Dysfunctional rectal symptoms EORTC QLQ‐PR25 questionnaire
NCT00884273, 2012 Axcrona 47 PCa all stages

LUTS relief

QoL improvement

IPSS
CHHiP, 2015 a Wilkins 17 pT1b–T3aN0M0

Overall bowel bother

Overall urinary bother

Overall sexual bother

General HRQoL

UCLA‐PCI, EPIC instrument

FACT‐P, SF‐36, SF‐12

CHHiP, 2016 a Dearnaley 48 pT1b–T3aN0M0 Patient reported outcome UCLA‐PCI, EPIC instrument
ACTRN12611000661976 a Yaxley 15 ≤T2cN0M0

Urinary function

Sexual function

Pain

Physical and mental functioning

Fatigue

Bowel function

Cancer‐specific distress

Psychological distress

Time to return to work

EPIC score

EPIC/ IIEF score

Surgical pain scale

SF‐36

Vitality domain SF‐36

EPIC score

RIES scale

HADS score

/

NCT00866554 Gaudet 49 T1c‐T2b, GS: 6 or 7(3 + 4), PSA ≤ 15

Acute and late effects on sexual function

Urinary toxicity

IPSS + EPIC score

IPSS + EPIC score

TROG 03.06 and VCOG PR 01‐03, 2017 Duchesne 50 PSA relapse after treatment or group two of asymptomatic men unsuitable for curative treatment because of age, comorbidity, or locally advanced disease Global HRQoL EORTC QLQ‐C30, EORTC QLQ‐PR25
TROG 03.06 and VCOG PR 01‐03, 2016 a Dushesne 51 PSA relapse after treatment or group two of asymptomatic men unsuitable for curative treatment because of age, comorbidity, or locally advanced disease Global HRQoL EORTC QLQ‐C30, EORTC QLQ‐PR25
MRC PATCH trial (PR09), 2016 Gilbert 52 cT3‐4cN + M0 or TxNxM1

Global health status/QoL

Urinary, bowel and sexual symptoms and function and hormone‐related symptoms

EORTC QLQ‐C30,

QLQ‐PR25

MRC PATCH trial (PR09), 2013 Langley 53 cT3‐4cN + M0 or TxNxM1 Adverse events (not patient reported) Not applicable
MRC PATCH trial (PR09), 2016 Langley 54 cT3‐4cN + M0 or TxNxM1 / /
ASCENDE‐RT trial, 2016 Rodda 55 High‐risk PCa: T3aN0M0, GS 8‐9, PSA > 20 HRQoL SF36v2
ASCENDE‐RT trial, 2013 a Morris 56 High‐risk PCa: T3aN0M0, GS 8‐9, PSA > 20 / /
PROSPER, 2018 a Hussain 57 nmCRPC QoL assessments /
PROSPER, 2019 Tombal 58 nmCRPC

Pain progression

HRQoL

BPI‐SF questionnaire

EORTC QLQ‐PR25

RTOG 0938, 2018 Lukka 59 Low risk PCa (cT1‐2aN0M0, PSA < 10, GS 2‐6)

Bowel and urinary PROs

% of patients with >5 point reduction in the EPIC bowel domain at 1 y

% of patients with >2 point reduction in EPIC urinary domain at 1 y

Sexual and hormonal toxicity

Acute/Late GI/GU toxicity

EPIC‐50

EPIC 50

EPIC 50

EPIC 50

EPIC 50

COMET‐2, 2018 Basch 60 mCRPC Rate of pain response BPI reports
SPARTAN, 2018 Saad 16 nmCRPC

HRQoL: PCa symptoms, pain‐related symptoms, and overall QoL

HRQoL: mobility, self‐care, usual activities, pain, discomfort, and anxiety or depression

EQ‐5D‐3L

FACT‐P

SPARTAN, 2018 a Smith 61 nmCRPC / /
NCT 02135357, 2018 Khalaf 62 mCRPC

Patient reported HRQoL

Depression symptoms

Cognitive function

FACT‐P

PHQ‐9

MoCA

NCT 02135357, 2018 Annala 63 mCRPC / /
SWOG S0421, 2018 Unger 64 mCRPC

Palliation of worst pain

Improvement of functional status

Vitality

General QoL

Analgesic use

BPI inventory

FACT‐P TOI

SF‐36 Energy/vitality scale

EORTC QLQ‐C30

(Pain medication logs)

SWOG S0421, 2013 Quinn 65 mCRPC / /
CHAARTED, 2015 a Sweeney 66 Metastatic hormone‐sensitive PCa / /
CHAARTED, 2018 Morgans 67 Metastatic hormone‐sensitive PCa

Overall QoL

Treatment and disease‐related QoL

Adverse effect of taxanes treatment

Fatigue

Pain

FACT‐P

FACT‐Taxane

FACIT‐Fatigue

BPI

LATITUDE, 2017 a Fizazi 68 Metastatic hormone‐sensitive PCa Time to pain progression BPI‐SF
LATITUDE, 2018 Chi 69 Metastatic hormone‐sensitive PCa

Pain

Fatigue

Disease‐related QoL

HRQoL

BPI‐SF

BFI

FACT‐P

EQ‐5D‐5L

Abbreviations: BPI, Brief Pain Inventory; EDITS, Erectile Dysfunction Inventory of Treatment Satisfaction; EORTC QLQ‐C30, European Organization for Research and Treatment of Cancer Quality of life questionnaire‐Core 30; EORTC QLQ‐PR25, European Organization for Research and Treatment of Cancer Quality of life questionnaire‐Prostate 25; EPIC, Expanded Prostate Index Composite questionnaire; EQ‐5D, EuroQol 5‐dimension; EQ‐5D‐3L, EuroQol 5‐dimension, 3‐level questionnaire; FACE, Functional Alterations due to Changes in Elimination; FACT‐P, Functional assessment of Cancer Therapy‐Prostate Cancer; HADS, Hospital Anxiety and Depression Scale; IIEF‐EF, International Index of Erectile Function‐Erectile Function; IPSS, International Prostate Symptom Score; MoCA, Montreal Cognitive Assessment;PHQ‐9, Patient Health Questionnaire‐9; RIES, Revised Impact of Events; SEAR, Self‐Esteem and Relationship questionnaire; SF‐36, Short‐Form 36; UCLA‐PCI, UCLA Prostate Cancer Index.

a

Included in the EAU prostate cancer guidelines.

HHS Vulnerability Disclosure