DaroAcT: 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)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Participants treated with darolutamide
|
Drug: Darolutamide(Nubeqa, BAY1841788)
600mg, twice daily
|
| Experimental: Participants treated with enzalutamide
|
Drug: Enzalutamide
160mg, once daily
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with a worsening in TUG (Time Up and Go) time [24-week period from baseline]
Secondary Outcome Measures
- Proportion of participants with an increase of at least 1 second in TUG time [Up to 52 weeks]
- Proportion of participants with a worsening in Short Physical Performance Battery (SPPB) total score [Up to 52 weeks]
- Mean change from baseline in daily physical activity as assessed by accelerometry [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 [Up to 52 weeks]
- Proportion of participants with a decline in cognitive function [Up to 52 weeks]
- Proportion of participants with a decline using a selected domain of FACT-Cog [Up to 52 weeks]
- Proportion of participants with a worsening of fatigue [Up to 52 weeks]
- Proportion of participants with an increase of at least 1 point in fatigue interference [Up to 52 weeks]
- Proportion of participants with a worsening in scores in the PHQ-9 [Up to 52 weeks]
- Number of participants with emergent AEs, SAEs, and AEs leading to study intervention discontinuation [Approximate 3 years]
- Number of participants with AEs of interest, including falls, fractures, and hypothyroidism [Approximate 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be 18 years of age inclusive or older at the time of signing the informed consent.
-
Participants who have:
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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
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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:
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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.
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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)
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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
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Prior or concurrent central nervous system disease, such as epilepsy, Parkinson's disease, Alzheimer's disease, dementia, or multiple sclerosis
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Non-ambulatory participants who need a wheelchair. Other assistive devices (e.g., cane or walker) are permitted.
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Clinically significant limitations in cognitive function and/or physical function, such as >20 seconds in the TUG assessment
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Prior treatment with any of the following:
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Second-generation AR inhibitors, such as enzalutamide, apalutamide, or Darolutamide
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Other investigational AR inhibitors
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Progression on abiraterone acetate and discontinuation within 6 months before signing the ICF for the study
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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.
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Use of immunotherapy within 28 days before the start of study intervention
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Treatment with radiotherapy/radiopharmaceuticals within 12 weeks before the start of study intervention
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health and Science University | Portland | Maine | United States | 97239 |
| 2 | New Jersey Urology, LLC | Voorhees | New Jersey | United States | 08043 |
| 3 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
| 4 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 5 | MidLantic Urology - Bala Cynwyd | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 6 | Bon Secours St. Francis Hospital | Greenville | South Carolina | United States | 29607 |
| 7 | Carolina Urological Research Center | Myrtle Beach | South Carolina | United States | 29579 |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20609