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)

NCT ID: NCT04157088

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2022-07-08

Brief Summary

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.

Conditions

Prostatic Cancer, Castration-Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants treated with darolutamide

Group Type: EXPERIMENTAL

Darolutamide (Nubeqa, BAY1841788)

Intervention Type: DRUG

600mg, twice daily

Participants treated with enzalutamide

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

160mg, once daily

Interventions

Darolutamide (Nubeqa, BAY1841788)

600mg, twice daily

Intervention Type: DRUG

Enzalutamide

160mg, once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

20609

Identifier Type: -

Identifier Source: org_study_id