Castration-resistant Prostate Cancer
Conditions
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.
Interventions
DRUGEnzalutamide
DRUGFlutamide
Sponsors
Astellas Pharma Inc
Taro Iguchi, MD, PHD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Testosterone of less than 50 ng/dL * 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.) * Participants who relapsed after CAB with bicalutamide * Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1 * Aged 20 years or older * Participants who provided written informed consent
Exclusion criteria
* Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy * With active double cancer * Any prior treatment with bicalutamide within 6 weeks * 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 * With serious complication * History of hypersensitivity to enzalutamide or any other excipient of enzalutamide * History of hypersensitivity to flutamide-containing agent * With liver dysfunction * Participants who are considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 | Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| QOL measured by functional assessment of cancer therapy-prostate (FACT-P) | Up to 39 months |
| 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 |
Countries
Japan
Outcome results
None listed