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The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase
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Researchers in this study want 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). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with darolutamide | Experimental |
| |
| Participants treated with enzalutamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darolutamide (Nubeqa, BAY1841788) | Drug | 600mg, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Worsening in TUG Time During the 24- Week Period. | 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 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 week, 24 week and 52 week. |
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Inclusion Criteria:
Participant must be 18 years of age inclusive or older at the time of signing the informed consent.
Participants who have:
Sex: Male
Exclusion Criteria:
Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis with abnormal renal function due to prostate cancer. Participants with visceral metastasis will be excluded.
Past (within 6 months before the start of study intervention) or concurrent stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, and/or congestive heart failure (New York Heart Association Class III or IV)
Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of the skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 3 years before the start of study intervention and from which the participant has been disease free
Prior or concurrent central nervous system disease, such as epilepsy, Parkinson's disease, Alzheimer's disease, dementia, or multiple sclerosis
Non-ambulatory participants who need a wheelchair. Other assistive devices (e.g., cane or walker) are permitted.
Clinically significant limitations in cognitive function and/or physical function, such as >20 seconds in the TUG assessment
Prior treatment with any of the following:
Use of immunotherapy within 28 days before the start of study intervention
Treatment with radiotherapy/radiopharmaceuticals within 12 weeks before the start of study intervention
Previous participation in other clinical studies within 28 days before the start of study treatment or 5 half-lives of the investigational treatment of the previous study, whichever is longer Diagnostic assessments
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Maine | 97239 | United States | ||
| New Jersey Urology, LLC |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2019 | Jun 12, 2023 |
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| Enzalutamide |
| Drug |
160mg, once daily |
|
| 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. | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | Up to 52 weeks in randomization phase |
| Voorhees Township |
| New Jersey |
| 08043 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MidLantic Urology - Bala Cynwyd | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Bon Secours St. Francis Hospital | Greenville | South Carolina | 29607 | United States |
| Carolina Urological Research Center | Myrtle Beach | South Carolina | 29579 | United States |
| Received Treatment |
|
| Participants Off-Study |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Short Physical Performance Battery (SPPB) | 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) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Counts per minute (CPM) | 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'. | 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. | Mean | Standard Deviation | Mean count per minute |
| |||||||||||||||
| Cognitive function: Hopkins Verbal Learning Test Revised (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. | 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. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||
| Cognitive function: Trail Making Test (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. | 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. | Mean | Standard Deviation | seconds |
| |||||||||||||||
| Cognitive function: Controlled Oral Word Association (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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Worsening in TUG Time During the 24- Week Period. | 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 | 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. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | At 12 week, 24 week and 52 week. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | From randomization to the first date a participant had a worsening. |
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| Secondary | 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) | 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. | Posted | Number | Participants | At 12 and 24 weeks and during the 24 weeks and 52 weeks from baseline |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Mean | Standard Deviation | Mean counts per minute | At 12 week, 24 week and 52 week |
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| Secondary | 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. | 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. | Posted | At 12, 24, and 52 weeks for the randomization phase |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Number | Participants | During the 24 weeks and 52 weeks from baseline. |
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| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Number | Participants | During the 24 weeks and 52 weeks from baseline. |
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| |||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Number | Participants | During the 24 weeks and 52 weeks from baseline. |
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| |||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Number | Participants | During the 24 weeks and 52 weeks from baseline. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Up to 52 weeks in randomization phase. |
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| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Count of Participants | Participants | At 24 weeks and 52 weeks |
|
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| Secondary | 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. | 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. | Posted | Up to 52 weeks in randomization phase |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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 | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
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| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | From randomization to the first date the participant had had a decline in KPS of at least 10 points. |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set: All enrolled participants who received any quantity of study intervention, regardless of their eligibility for the study. | Posted | Number | Participants | Up to 52 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Up to 52 weeks in randomization phase |
|
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| Secondary | 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. | 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. | Posted | From randomization to the time when the criteria for PSA progression (according to PCWG3) was met, up to 52 weeks. |
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| |||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Up to 52 weeks in randomization phase |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 30 | 6 | 30 | 21 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
|
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.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2021 | Jun 12, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607739 | darolutamide |
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| HVLT-R DR |
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| HVLT-R RECOG |
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| TMTB |
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| During the 24-week period |
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