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) (DaroAcT)
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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.
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
Actual Study Start Date :
December 17, 2019
Estimated Primary Completion Date :
December 31, 2022
Estimated Study Completion Date :
December 31, 2022
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Proportion of participants with a worsening in TUG (Time Up and Go) time [ Time Frame: 24-week period from baseline ]
Secondary Outcome Measures :
Proportion of participants with an increase of at least 1 second in TUG time [ Time Frame: Up to 52 weeks ]
Proportion of participants with a worsening in Short Physical Performance Battery (SPPB) total score [ Time Frame: Up to 52 weeks ]
Mean change from baseline in daily physical activity as assessed by accelerometry [ Time 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 [ Time Frame: Up to 52 weeks ]
Proportion of participants with a decline in cognitive function [ Time Frame: Up to 52 weeks ]
Proportion of participants with a decline using a selected domain of FACT-Cog [ Time Frame: Up to 52 weeks ]
Proportion of participants with a worsening of fatigue [ Time Frame: Up to 52 weeks ]
Proportion of participants with an increase of at least 1 point in fatigue interference [ Time Frame: Up to 52 weeks ]
Proportion of participants with a worsening in scores in the PHQ-9 [ Time Frame: Up to 52 weeks ]
Number of participants with emergent AEs, SAEs, and AEs leading to study intervention discontinuation [ Time Frame: Approximate 3 years ]
Number of participants with AEs of interest, including falls, fractures, and hypothyroidism [ Time Frame: Approximate 3 years ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
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Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male