Table 3.

Assessment tools and patient-reported outcomes in recent clinical trials with patients with CRPC.

Trial	Assessment tools				AEs†	Significant assessment outcomes (drug vs PBO)‡
	Cognitive	QoL	Fatigue	Pain
Enzalutamide
PROSPER [50, 90] NCT02003924		FACT-P EQ-5D-5L EQ-VAS EORTC QLQ-PR25		BPI-SF	Weight decrease Decreased appetite Fatigue Asthenia Fall Mental impairment disorders	BPI-SF (pain severity): time to progression 36.83 months vs NR; HR 0.75 (95% CI 0.57–0.97; P = 0.028) FACT-P total score: time to deterioration in HRQoL 22.11 vs 18.43 months; HR 0.83 (95% CI 0.69–0.99; P = 0.037) EORTC QLQ-PR25: time to deterioration in HRQoL Bowel symptoms and function: 33.15 vs 25.89 months; HR 0.72 (95% CI 0.59–0.89; P = 0.0018) Hormonal treatment-related symptoms: 33.15 vs 36.83 months; HR 1.29 (95% CI 1.02–1.63; P = 0.035) Urinary symptoms: 36.86 vs 25.86 months; HR 0.58 (95% CI 0.46–0.72; P < 0.0001) EQ-VAS: time to deterioration in HRQoL 22.11 vs 14.75 months; HR 0.75 (95% CI 0.63–0.90; P = 0.0013)
PREVAIL [52, 105] NCT01212991		EQ-5D-3L EQ-VAS FACT-P			Fatigue Arthralgia Asthenia Weight loss Back pain Decreased appetite Fall	EQ-5D-3L (total score): average decline −0.042 vs −0.070 points (P < 0.0001) EQ-VAS: average decline −1.3 vs −4.4 points (P < 0.0001) FACT-P total score: time to deterioration in HRQoL 11.3 vs 5.6 months; HR 0.63 (95% CI 0.54–0.72; P < 0.001)
AFFIRM [53] NCT00974311		FACT-P		BPI-SF	Fatigue Musculoskeletal pain	BPI-SF (question no. 3; <4 vs ≥4): mean pain score HR for death 0.79 (95% CI 0.65–0.97; P = 0.02) FACT-P: quality of life response (10-point improvement in total score compared with baseline) 43% vs 18% (P < 0.001)
Apalutamide
SPARTAN [54, 89] NCT01946204		FACT-P EQ-VAS EQ-5D-3L			Weight decrease Arthralgia Fatigue Fracture Fall	FACT-P: change in total score from baseline to 29 months −0.99 ± 0.98 vs −3.29 ± 1.97 EQ-VAS: change in total score from baseline to 29 months 1.44 ± 0.87 vs 0.26 ± 1.75 EQ-5D-3L (total score): similar preservation of HRQoL from baseline
Darolutamide
ARAMIS [56] NCT02200614		FACT-P EQ-5D-3L EORTC QLQ-PR25		BPI-SF	Fatigue║	BPI-SF (pain inference): least-squares mean, time-adjusted AUC 1.1 vs 1.3 points; difference −0.2 (95% CI − 0.3 to −0.1) BPI-SF (pain severity): least-squares mean time-adjusted AUC 1.3 vs 1.4 points; difference −0.2 (95% CI − 0.3 to −0.1) FACT-P (total score): least-squares means, time-adjusted AUC 112.9 vs 111.6 points; difference 1.3; 95% CI 0.4–2.1

^†AEs that are likely to affect the physical activity of patients and occurred with a ≥ 2% incidence in patients in the treatment group compared with the placebo group (arthralgia, asthenia, bone pain, decreased appetite, dizziness, falls, fatigue, fractures, mental impairment disorders, pain, weight loss).

^‡Only significant results are reported in this table.

^§None of the AEs reported met the inclusion criteria for this table.

^║Grouped terms, for more information, see ref. [56].

ADT androgen deprivation therapy, AE adverse event, AUC area under the curve, BFI-SF Brief Fatigue Inventory Short Form, BPI-SF Brief Pain Inventory Short Form, C30 30-item core questionnaire, CI confidence interval, CRPC castration-resistant prostate cancer, EORTC QLQ European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire,  EQ-5D-3L EuroQol 5-Dimensions 3-Levels health questionnaire, EQ-5D-5L EuroQoL 5-Dimensions 5-Levels health questionnaire, EQ-VAS EuroQoL 5-Dimensions 5-Levels health questionnaire visual analog scale, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue, FACT-Cog Functional Assessment of Cancer Therapy-Cognition, FACT-P Functional Assessment of Cancer Therapy-Prostate, HRQoL health-related quality of life, PBO placebo, PHQ-9 Patient Health Questionnaire-9, PR25 prostate cancer-specific 25-item questionnaire, QoL quality of life.