Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.

Worsening was defined as an increase of at least 1 second in TUG time from baseline. Improved was defined at least 1 second decrease from baseline. Stable was defined as change from baseline between less than 1 second increase and less than 1 second decrease.

Time frame: At 12 week, 24 week and 52 week.

Time to Worsening (Increase of at Least 1 Second) in TUG Time

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: From randomization to the first date a participant had a worsening.

Number of Participants With a Worsening in SPPB Total Score at 12 and 24 Weeks and During the 24 Weeks and 52 Weeks From Baseline.

The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance)

Time frame: At 12 and 24 weeks and during the 24 weeks and 52 weeks from baseline

Mean Change From Baseline in Daily Physical Activity as Assessed by CPM, at 12 and 24 Weeks, and During the 24 Weeks and 52 Weeks From Baseline.

Participants required at least 2 valid days to be included in the analysis at each visit. 'Valid' is defined as at least 10 awake wear hours. CPM for each valid day is defined as 'awake wear-filtered total vector magnitude counts' divided by 'awake wear minutes''. A participant's CPM at each visit is the average of daily CPM.

Time frame: At 12 week, 24 week and 52 week

Mean Change From Baseline in Accelerometer-assessed Proportion of Time Spent in Light to Vigorous Physical Activity Based on a Threshold of >100 Activity Counts Per Minute.

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: At 12, 24, and 52 weeks for the randomization phase

Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.

The HVLT-R is a learning and memory test, in which the participant is asked to learn and recall a list of 12 words over three trials. The HVLT-R TR (total score) score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall. The HVLT-R DR (delayed recall) score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall. The HVLT-R RECOG (Delayed Recognition) score ranges from -12 to 12, where higher scores indicated better performance.

Time frame: During the 24 weeks and 52 weeks from baseline.

Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.

TMT Part A (TMTA) is timed up to a maximum of 3 minutes, and TMT Part B (TMTB) is timed up to a maximum of 5 minutes. The lower score indicated the better performance.

Time frame: During the 24 weeks and 52 weeks from baseline.

Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by COWA.

The COWA test assessed lexical fluency. Given a specific letter of the alphabet, participants were required to produce as many words as possible that begin with that letter. There were two alternate forms of the COWA, each with three unique letter exemplars. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function.

Time frame: During the 24 weeks and 52 weeks from baseline.

Number of Participants With a Decline Using a Selected Domain of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).

FACT-Cog with a range of 0-28 points, higher score is better. Decline was defined as a decrease of \>10 points during the 24 weeks and 52 weeks from baseline.

Time frame: During the 24 weeks and 52 weeks from baseline.

Number of Participants With a Worsening of Fatigue During the 24 Weeks and 52 Weeks.

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: Up to 52 weeks in randomization phase.

Number of Participants With an Increase of at Least 1 Point in Fatigue Interference by 24 Weeks and 52 Weeks From Baseline (Based on Items 4A-F of the BFI)

Fatigue Interference decline is defined as an increase of at least 1 point in any Fatigue Interference from baseline. BFI: Brief Fatigue Inventory. BFI is a 5 minute self-assessment tool that identifies fatigue in cancer participants over a 24-hour period.

Time frame: At 24 weeks and 52 weeks

Number of Participants With a Worsening in Scores in the PHQ-9 During the 24 Weeks and 52 Weeks From Baseline.

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: Up to 52 weeks in randomization phase

Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation

Treatment-Emergent Adverse Events (TEAEs) were defined as any events arising or worsening after the first dose of study drug until 30 days after last dose. SAEs: Serious adverse events

Time frame: Up to 52 weeks

Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism

AEs of interest were followed up regardless of causality or relationship to study intervention.

Time frame: Up to 52 weeks

Time to Deterioration of Karnofsky Performance Scale (KPS) Defined as at Least a 10 Point Decline From Baseline.

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: From randomization to the first date the participant had had a decline in KPS of at least 10 points.

Number of Participants With Treatment Exposure of the Study Intervention Including Time on Treatment

A total of 30 participants received treatment with darolutamide 600 mg twice daily in the lead-in phase of the study, comprising the safety evaluable population. No participant received either darolutamide or enzalutamide in the randomized phase of the study as the study was terminated prematurely prior to the initiation of the randomized phase of the study.

Time frame: Up to 52 weeks

Number of Participants With Dose Reductions of Study Intervention

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: Up to 52 weeks in randomization phase

Time to Prostate-specific Antigen (PSA) Progression (as Per Prostate Cancer Working Group [PCWG3] Criteria)

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: From randomization to the time when the criteria for PSA progression (according to PCWG3) was met, up to 52 weeks.

Survival Status

At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.

Time frame: Up to 52 weeks in randomization phase