Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
Study Details
Study Description
Brief Summary
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Enzalutamide Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules |
Drug: Enzalutamide
|
Active Comparator: Flutamide Flutamide 125 mg administered orally three times a day as one tablet after meal |
Drug: Flutamide
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 [Month 3]
Secondary Outcome Measures
- Percentage of participants whose PSA decreased 50 percent or more at month 6 [Month 6]
- Percentage of participants who showed disease progression at month 3 [Month 3]
- Percentage of participants who showed disease progression at month 6 [Month 6]
- PSA progression-free survival (PFS) [Up to 39 months]
- QOL measured by functional assessment of cancer therapy-prostate (FACT-P) [Up to 39 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Testosterone of less than 50 ng/dL
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Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
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Participants who relapsed after CAB with bicalutamide
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Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
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Aged 20 years or older
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Participants who provided written informed consent
Exclusion Criteria:
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Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
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With active double cancer
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Any prior treatment with bicalutamide within 6 weeks
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Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
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With serious complication
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History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
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History of hypersensitivity to flutamide-containing agent
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With liver dysfunction
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Participants who are considered as inadequate by the investigator
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Osaka City University Graduate School of Medicine | Osaka | Japan |
Sponsors and Collaborators
- Taro Iguchi, MD, PHD
- Astellas Pharma Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- OCUU-CRPC