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)

Stopped early · Phase 2

Conditions studied: Prostatic Cancer, Castration-Resistant

In brief

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 facts

Study ID: NCT04157088
Run by: Bayer
People needed: 30
Starts: 2019-12-17
Expected to finish: 2022-07-08
Last updated by the study team: 2023-08-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Oregon Health and Science University — Portland, Maine, United States
New Jersey Urology, LLC — Voorhees Township, New Jersey, United States
Montefiore Medical Center — The Bronx, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
MidLantic Urology - Bala Cynwyd — Bala-Cynwyd, Pennsylvania, United States
Bon Secours St. Francis Hospital — Greenville, South Carolina, United States
Carolina Urological Research Center — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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