stop_circleTerminated/Withdrawn

Prostatic Cancer, Castration-Resistant

Bayer Identifier:

20609

ClinicalTrials.gov Identifier:

NCT04157088

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

Male

Age

18 - N/A
  • - Participant must be 18 years of age inclusive or older at the time of signing the informed consent.
    - Participants who have:
     -- Histologically or cytologically confirmed adenocarcinoma of prostate, CRPC (Castration-resistant prostate cancer) defined by disease progression despite ADT (Androgen deprivation therapy) and may present as either a confirmed rise in serum PSA (Prostate-specific antigen) levels (as defined by PCWG3 (Prostate Cancer Working Group)), the progression of pre-existing disease, and/or the appearance of new metastases. Metastatic and non-metastatic CRPC patients will be eligible.
     -- KPS (Karnofsky Performance Scale) performance status of ≥80
     -- Blood counts at screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1500/μL, platelet count ≥100,000/μL
     -- Screening values of serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN), total bilirubin ≤1.5 × ULN, creatinine ≤2.0 × ULN
     -- Life expectancy of at least 1 year
    - Sex: Male
  • - 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:
     -- Second-generation AR inhibitors, such as enzalutamide, apalutamide, or Darolutamide
     -- Other investigational AR inhibitors
     -- Progression on abiraterone acetate and discontinuation within 6 months before signing the ICF for the study
     -- For mCRPC participants: any chemotherapy, and/or >2 prior lines of systemic anticancer treatment. Treatment with an LHRH agonist, LHRH antagonists, or orchidectomy is not counted as systemic treatment with regard to this exclusion criterion.
    - 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

Trial summary

Enrollment Goal
30
Trial Dates
December 2019 - July 2022
Phase
Phase 2
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
GU Research Network, LLCOmaha, 68130, United States
Withdrawn
Henry Ford Health SystemDetroit, 48202, United States
Withdrawn
Inova Schar Cancer InstituteFairfax, 22031, United States
Withdrawn
Seattle Cancer Care AllianceSeattle, 98109, United States
Withdrawn
Spokane Urology PSSpokane, 99202, United States
Withdrawn
Manatee Medical Research InstituteBradenton, 34205, United States
Withdrawn
University of California, Los AngelesLos Angeles, 90095, United States
Withdrawn
Associated Urologists of North CarolinaRaleigh, 27612, United States
Withdrawn
Associated Medical Professionals of NY, PLLCSyracuse, 13210, United States
Completed
Carolina Urological Research CenterMyrtle Beach, 29579, United States
Completed
MidLantic Urology - Bala CynwydBala Cynwyd, 19004, United States
Completed
Bon Secours St. Francis HospitalGreenville, 29607, United States
Withdrawn
Dana-Farber Cancer InstituteBoston, 02215, United States
Completed
Montefiore Medical CenterBronx, 10461, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
New Jersey Urology, LLCVoorhees, 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 time
    date_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 minute
    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 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 discontinuation
    date_rangeTime Frame:
    Approximate 3 years
  • Number of participants with AEs of interest, including falls, fractures, and hypothyroidism
    date_rangeTime Frame:
    Approximate 3 years
  • Time to deterioration of KPS defined as at least a 10 point decline from baseline
    date_rangeTime Frame:
    Up to 52 weeks
  • Number of participants with treatment exposure of the study intervention including time on treatment
    date_rangeTime Frame:
    Up to 52 weeks
  • Number of participants with dose reductions of study intervention
    date_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 status
    date_rangeTime Frame:
    Up to 52 weeks

Trial design

A randomized, open-label, multicenter, Phase 2b study to evaluate physical function, including balance and daily activity, in participants with castration-resistant prostate cancer treated with darolutamide or enzalutamide
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2