Trial Outcomes & Findings for 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) (NCT NCT04157088)
NCT ID: NCT04157088
Last Updated: 2023-08-04
Results Overview
TUG: Timed Up \& Go. Worsening is defined as an increase of at least 1 second in TUG time from baseline. (The minimum clinically important difference \[MCID\] in TUG time is 1 second
TERMINATED
PHASE2
30 participants
Up to 24 weeks
2023-08-04
Participant Flow
The study was conducted at 7 centers in United States of America (USA) between 17 Dec 2019 (First participant first visit) and 08 JUL 2022 (Last participant last visit).
40 participants were screened into the study (signed informed consent form (ICF)). 10 participants failed screening as they did not meet the inclusion/exclusion criteria. None of these patients received treatment. 30 participants were enrolled in the study, all 30 participants only received the darolutamide treatment during the lead-in phase as the study was terminated prior to the initiation of the randomized phase.
Participant milestones
| Measure |
Participants Treated With Darolutamide
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Received Treatment
|
30
|
|
Overall Study
Participants Off-Study
|
30
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Participants Treated With Darolutamide
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Overall Study
Study terminated by sponsor
|
23
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 27 received this intervention.
Baseline characteristics by cohort
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 8.18 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=30 Participants
|
|
Short Physical Performance Battery (SPPB)
|
8.17 units on a scale
STANDARD_DEVIATION 1.577 • n=30 Participants
|
|
Counts per minute (CPM)
|
1900.4 Mean count per minute
STANDARD_DEVIATION 448.442 • n=27 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 27 received this intervention.
|
|
Cognitive function: Hopkins Verbal Learning Test Revised (HVLT-R)
HVLT-R TR
|
19.2 units on a scale
STANDARD_DEVIATION 6.24 • n=30 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 29 received the HVLT-R DR and HVLT-R RECOG interventions.
|
|
Cognitive function: Hopkins Verbal Learning Test Revised (HVLT-R)
HVLT-R DR
|
7.1 units on a scale
STANDARD_DEVIATION 3.14 • n=29 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 29 received the HVLT-R DR and HVLT-R RECOG interventions.
|
|
Cognitive function: Hopkins Verbal Learning Test Revised (HVLT-R)
HVLT-R RECOG
|
9.1 units on a scale
STANDARD_DEVIATION 2.48 • n=29 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 29 received the HVLT-R DR and HVLT-R RECOG interventions.
|
|
Cognitive function: Trail Making Test (TMT)
TMTA
|
50.4 seconds
STANDARD_DEVIATION 31.46 • n=30 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 30 performed the TMTA intervention, 29 received the TMTB intervention.
|
|
Cognitive function: Trail Making Test (TMT)
TMTB
|
113.0 seconds
STANDARD_DEVIATION 64.17 • n=29 Participants • The number of all enrolled participants is n=30. The full analysis set FAS considers all enrolled participants who signed the ICF, n=30. The safety analysis set SAF considers all enrolled participants that have actually received an intervention. Of 30 participants, 30 performed the TMTA intervention, 29 received the TMTB intervention.
|
|
Cognitive function: Controlled Oral Word Association (COWA)
|
31.7 units on a scale
STANDARD_DEVIATION 13.87 • n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Full analysis set: All enrolled participants (30). 2 participants were excluded from analysis due to screening assessment performed in 4 meters instead of 3 meters.
TUG: Timed Up \& Go. Worsening is defined as an increase of at least 1 second in TUG time from baseline. (The minimum clinically important difference \[MCID\] in TUG time is 1 second
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=28 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
At week 12
|
5 Participants
|
|
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
At week 24
|
5 Participants
|
|
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
During the 24-week period
|
8 Participants
|
SECONDARY outcome
Timeframe: At 12 week, 24 week and 52 week.Population: Full analysis set: All enrolled participants (30). 2 participants were excluded from analysis due to screening assessment performed in 4 meters instead of 3 meters.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=28 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 12_Stable
|
15 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 12_Worsen
|
5 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 12_ Improved
|
2 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 24_Stable
|
17 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 24_Worsen
|
5 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 24_ Improved
|
1 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 52_Stable
|
14 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 52_Worsen
|
5 Participants
|
|
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
At week 52_ Improved
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to the first date a participant had a worsening.Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 and 24 weeks and during the 24 weeks and 52 weeks from baselinePopulation: Full analysis set: All enrolled participants (30). 1 participant at week 24 visit was excluded from analysis due to being performed outside of visit window.
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)
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
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.
At week 12
|
3 Participants
|
|
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.
At week 24
|
8 Participants
|
|
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.
At week 52
|
7 Participants
|
SECONDARY outcome
Timeframe: At 12 week, 24 week and 52 weekPopulation: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
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.
At week 12
|
60.04 Mean counts per minute
Standard Deviation 266.480
|
|
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.
At week 24
|
83.74 Mean counts per minute
Standard Deviation 455.580
|
|
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.
At week 52
|
-37.73 Mean counts per minute
Standard Deviation 304.621
|
SECONDARY outcome
Timeframe: At 12, 24, and 52 weeks for the randomization phasePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the 24 weeks and 52 weeks from baseline.Population: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R TR_At week 24
|
5 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R TR_At week 52
|
5 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R DR_At week 24
|
4 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R DR_At week 52
|
3 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R RECOG_At week 24
|
5 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
HVLT-R RECOG_At week 52
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 24 weeks and 52 weeks from baseline.Population: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
TMTA_At week 24
|
5 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
TMTA_At week 52
|
3 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
TMTB_At week 24
|
6 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
TMTB_At week 52
|
4 Participants
|
SECONDARY outcome
Timeframe: During the 24 weeks and 52 weeks from baseline.Population: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by COWA.
At week 24
|
3 Participants
|
|
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by COWA.
At week 52
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 24 weeks and 52 weeks from baseline.Population: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With a Decline Using a Selected Domain of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).
During the 24-week period
|
0 Participants
|
|
Number of Participants With a Decline Using a Selected Domain of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).
During the 52-week period
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks in randomization phase.Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 weeks and 52 weeksPopulation: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
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)
During the 12 week period
|
10 Participants
Interval 17.9 to 54.3
|
|
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)
During the 24 week period
|
12 Participants
Interval 23.5 to 61.1
|
|
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)
During the 52 week period
|
13 Participants
Interval 26.4 to 64.3
|
SECONDARY outcome
Timeframe: Up to 52 weeks in randomization phasePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation
TEAEs
|
26 Participants
|
|
Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation
AEs leading to study intervention discontinuation
|
3 Participants
|
|
Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation
SAEs
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
AEs of interest were followed up regardless of causality or relationship to study intervention.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
Falls
|
1 Participants
|
|
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
Fractures
|
1 Participants
|
|
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
Hypothyroidism
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to the first date the participant had had a decline in KPS of at least 10 points.Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study.
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.
Outcome measures
| Measure |
Participants Treated With Darolutamide
n=30 Participants
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Number of Participants With Treatment Exposure of the Study Intervention Including Time on Treatment
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks in randomization phasePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the time when the criteria for PSA progression (according to PCWG3) was met, up to 52 weeks.Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeks in randomization phasePopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Participants Treated With Darolutamide
Serious adverse events
| Measure |
Participants Treated With Darolutamide
n=30 participants at risk
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Cardiac disorders
Aortic valve disease
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Infections and infestations
COVID-19
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Nervous system disorders
Spinal cord compression
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.3%
1/30 • Number of events 1 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
Other adverse events
| Measure |
Participants Treated With Darolutamide
n=30 participants at risk
Participants treated with darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
General disorders
Fatigue
|
26.7%
8/30 • Number of events 8 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
General disorders
Oedema peripheral
|
6.7%
2/30 • Number of events 3 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Infections and infestations
COVID-19
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • Number of events 3 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
3/30 • Number of events 3 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Number of events 4 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
5/30 • Number of events 5 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
3/30 • Number of events 3 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Number of events 4 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
|
Vascular disorders
Hot flush
|
6.7%
2/30 • Number of events 2 • Timeframe for TEAEs: after the first dose of study drug until 30 days after last dose, with a maximum duration of 815 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with a maximum duration of 847 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER