stop_circleTerminated/Withdrawn
Prostatic Cancer, Castration-Resistant
Bayer Identifier:
20609
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
30Trial Dates
December 2019 - July 2022Phase
Phase 2Could I Receive a placebo
NoProducts
Nubeqa (Darolutamide, BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | GU Research Network, LLC | Omaha, 68130, United States |
Withdrawn | Henry Ford Health System | Detroit, 48202, United States |
Withdrawn | Inova Schar Cancer Institute | Fairfax, 22031, United States |
Withdrawn | Seattle Cancer Care Alliance | Seattle, 98109, United States |
Withdrawn | Spokane Urology PS | Spokane, 99202, United States |
Withdrawn | Manatee Medical Research Institute | Bradenton, 34205, United States |
Withdrawn | University of California, Los Angeles | Los Angeles, 90095, United States |
Withdrawn | Associated Urologists of North Carolina | Raleigh, 27612, United States |
Withdrawn | Associated Medical Professionals of NY, PLLC | Syracuse, 13210, United States |
Completed | Carolina Urological Research Center | Myrtle Beach, 29579, United States |
Completed | MidLantic Urology - Bala Cynwyd | Bala Cynwyd, 19004, United States |
Completed | Bon Secours St. Francis Hospital | Greenville, 29607, United States |
Withdrawn | Dana-Farber Cancer Institute | Boston, 02215, United States |
Completed | Montefiore Medical Center | Bronx, 10461, United States |
Completed | Oregon Health and Science University | Portland, 97239, United States |
Completed | Duke University Medical Center | Durham, 27710, United States |
Completed | New Jersey Urology, LLC | Voorhees, 08043, United States |
Primary Outcome
- Number of participants with a worsening in TUG time during the 24- week period.date_rangeTime Frame:24-week period from baseline
Secondary Outcome
- Number of participants with an increase of at least 1 second in TUG time at 12 and 24 weeks and during the 52 weeks.date_rangeTime Frame:Up to 52 weeks
- Time to worsening (increase of at least 1 second) in TUG timedate_rangeTime Frame:Up to 52 weeks
- 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.date_rangeTime Frame:Up to 52 weeks
- Mean change from baseline in daily physical activity at 12 and 24 weeks, and during the 24 weeks and 52 weeks from baseline.date_rangeTime Frame:Up to 52 weeks
- 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 minutedate_rangeTime Frame:Up to 52 weeks
- Number of participants with a decline in cognitive function during the 24 weeks and 52 weeks from baseline, as assessed by Hopkins Verbal Learning Test Revised (HVLT-R).date_rangeTime Frame:Up to 52 weeks
- Number of participants with a decline in cognitive function during the 24 weeks and 52 weeks from baseline, as assessed by Trail Making Test (TMT).date_rangeTime Frame:Up to 52 weeks
- Number of participants with a decline in cognitive function during the 24 weeks and 52 weeks from baseline, as assessed by Controlled Oral Word Association (COWA).date_rangeTime Frame:Up to 52 weeks
- Number of participants with a decline using a selected domain of FACT-Cog.date_rangeTime Frame:Up to 52 weeks
- Number of participants with a worsening of fatigue during the 24 weeks and 52 weeks.date_rangeTime Frame:Up to 52 weeks
- 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)date_rangeTime Frame:Up to 52 weeks
- Number of participants with a worsening in scores in the PHQ-9 during the 24 weeks and 52 weeks from baseline.date_rangeTime Frame:Up to 52 weeks
- Number of participants with treatment emergent AEs, SAEs, and AEs leading to study intervention discontinuationdate_rangeTime Frame:Approximate 3 years
- Number of participants with AEs of interest, including falls, fractures, and hypothyroidismdate_rangeTime Frame:Approximate 3 years
- Time to deterioration of KPS defined as at least a 10 point decline from baselinedate_rangeTime Frame:Up to 52 weeks
- Number of participants with treatment exposure of the study intervention including time on treatmentdate_rangeTime Frame:Up to 52 weeks
- Number of participants with dose reductions of study interventiondate_rangeTime Frame:Up to 52 weeks
- Time to prostate-specific antigen (PSA) progression (as per Prostate Cancer Working Group [PCWG3] criteria)date_rangeTime Frame:Up to 52 weeks
- Survival statusdate_rangeTime Frame:Up to 52 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2