Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer
NCT ID: NCT04409288
Last Updated: 2024-01-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-20
Study Completion Date
2023-10-16
Brief Summary
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This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer. The primary objective is to investigate whether there is any difference in patient preference between apalutamide and enzalutamide in patients with recurrent or metastatic hormone-sensitive prostate cancer.
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Detailed Description
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This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer The primary outcome is patient preference, which serves as an indicator covering different aspects of treatment-related effects, and this would be most important in a patient's perspective. The quality of life, psychological and cognitive changes following apalutamide and enzalutamide in a comprehensive manner will be investigated.
Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient, physician and caregiver preferences will be assessed at the end of the second treatment period. Other secondary outcomes on health-related quality of life measures, psychological assessment scores and cognitive assessment scores shall be assessed before and the end of first treatment and second treatment period.
Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient, physician and caregiver preferences will be assessed at the end of the second treatment period. Other secondary outcomes on health-related quality of life measures, psychological assessment scores and cognitive assessment scores shall be assessed before and the end of first treatment and second treatment period.
Conditions
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Prostate Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Group A
Apalutamide followed by Enzalutamide Study participants will receive 12 weeks of oral apalutamide (240mg) daily, followed by five weeks of washout period, and then 12 weeks of oral enzalutamide (160mg) daily.
Group Type
EXPERIMENTAL
Apalutamide
Intervention Type
DRUG
Androgen receptor inhibitor.
Enzalutamide
Intervention Type
DRUG
Androgern receptor inhibitor
Group B
Enzalutamide followed by Apalutamide Study participants will receive 12 weeks of oral enzalutamide (160mg) daily, followed by five weeks of washout period, and then 12 weeks of oral apalutamide (240mg) daily.
Group Type
EXPERIMENTAL
Apalutamide
Intervention Type
DRUG
Androgen receptor inhibitor.
Enzalutamide
Intervention Type
DRUG
Androgern receptor inhibitor
Interventions
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Apalutamide
Androgen receptor inhibitor.
Intervention Type
DRUG
Enzalutamide
Androgern receptor inhibitor
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. 18 years old or above with informed consent
2. Histological diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Androgen deprivation therapy started at least 28 days prior to randomization
5. Patients should be having one of the following diseases and treatment conditions:
1. Recurrent prostate cancer following radical prostatectomy or radiotherapy, which do not fall into high-risk or high-volume categories
2. Metastatic hormone-sensitive prostate cancer, which do not fall into high-risk or high-volume categories
2. Histological diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Androgen deprivation therapy started at least 28 days prior to randomization
5. Patients should be having one of the following diseases and treatment conditions:
1. Recurrent prostate cancer following radical prostatectomy or radiotherapy, which do not fall into high-risk or high-volume categories
2. Metastatic hormone-sensitive prostate cancer, which do not fall into high-risk or high-volume categories
Exclusion Criteria
1. Patients with high-volume metastatic hormone-sensitive prostate cancer, defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis
2. Patients with high-risk metastatic hormone-sensitive prostate cancer, defined by having at least two of the three following factors - a Gleason score above 7, having at least 3 bone metastasis or presence of measurable visceral metastasis
3. Presence of brain metastasis
4. Use of bisphosphonate or denosumab within 28 days prior to randomization
5. Use of older anti-androgens, including flutamide and bicalutamide, for flare protection, within 28 days prior to randomization
6. Prior use of chemotherapy, immunotherapy, radiopharmaceutical agents, CYP17 inhibitors (e.g. abiraterone acetate), enzalutamide or apalutamide for the treatment of prostate cancer or prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis
7. History of seizure or any condition that may predispose to seizure (e.g., neurological disorder, prior cortical stroke or significant brain trauma)
8. Use of an investigational agent within 4 weeks of randomization
9. Hypersensitivity reaction to the active pharmaceutical ingredient
10. Clinically significant cardiovascular disease including the following:
1. Myocardial infarction within 6 months before screening;
2. Uncontrolled angina within 3 months before screening;
3. Congestive heart failure New York Heart Association class 3 or 4, or a history of congestive heart failure New York Heart Association class 3 or 4, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before randomization demonstrates a left ventricular ejection fraction ≥ 50%;
4. History of clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
5. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
6. Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening;
7. Bradycardia as indicated by a heart rate of \< 45 beats per minute on the screening electrocardiogram and on physical examination;
8. Uncontrolled hypertension as indicated by systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg at screening
11. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within 3 months before randomization)
12. Major surgery within 28 days of randomization
13. Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator
2. Patients with high-risk metastatic hormone-sensitive prostate cancer, defined by having at least two of the three following factors - a Gleason score above 7, having at least 3 bone metastasis or presence of measurable visceral metastasis
3. Presence of brain metastasis
4. Use of bisphosphonate or denosumab within 28 days prior to randomization
5. Use of older anti-androgens, including flutamide and bicalutamide, for flare protection, within 28 days prior to randomization
6. Prior use of chemotherapy, immunotherapy, radiopharmaceutical agents, CYP17 inhibitors (e.g. abiraterone acetate), enzalutamide or apalutamide for the treatment of prostate cancer or prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis
7. History of seizure or any condition that may predispose to seizure (e.g., neurological disorder, prior cortical stroke or significant brain trauma)
8. Use of an investigational agent within 4 weeks of randomization
9. Hypersensitivity reaction to the active pharmaceutical ingredient
10. Clinically significant cardiovascular disease including the following:
1. Myocardial infarction within 6 months before screening;
2. Uncontrolled angina within 3 months before screening;
3. Congestive heart failure New York Heart Association class 3 or 4, or a history of congestive heart failure New York Heart Association class 3 or 4, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before randomization demonstrates a left ventricular ejection fraction ≥ 50%;
4. History of clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
5. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
6. Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening;
7. Bradycardia as indicated by a heart rate of \< 45 beats per minute on the screening electrocardiogram and on physical examination;
8. Uncontrolled hypertension as indicated by systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg at screening
11. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within 3 months before randomization)
12. Major surgery within 28 days of randomization
13. Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Janssen, LP
INDUSTRY
Sponsor Role
collaborator
Chinese University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Chi Fai NG
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chi Fai NG, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Shatin, , Hong Kong
Site Status
Countries
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Hong Kong
References
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Other Identifiers
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56021927PCR3012
Identifier Type: -
Identifier Source: org_study_id
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