TABLE 2.
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.
Included in the EAU prostate cancer guidelines.