None listed
Conditions
Interventions
Drug : 1. Experimental group
Xtandi soft capsule 40mg(enzalutamide)
160mg/day, Once per day
Continue until radiographic progression as specified in the protocol.
oral
2. Control group
Xtandi sof
Sponsors
Novotech Asia Korea
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older and willing and able to provide informed consent; 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features; 3. Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration); 4. Testosterone = 50 ng/dL (= 1.73 nmol/L) at screening; 5. For patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization; 6. Progressive disease on androgen deprivation therapy at enrollment defined as a minimum of 3 rising PSA values (PSA1 < PSA2 < PSA3) assessed by a local laboratory (local PSA) with an interval of = 1 week between each determination; and so on.
Exclusion criteria
Exclusion criteria: 1. Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo); 2. Treatment with hormonal therapy (eg, androgen receptor inhibitors, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization; 3. Use of an investigational agent within 4 weeks of randomization; 4. Known or suspected brain metastasis or active leptomeningeal disease; 5. History of another invasive cancer within 3 years of randomization, with the exception of fully treated cancers with a remote probability of recurrence in the opinion of both the medical monitor and investigator; and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| metastasis-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to pain progression;Time to opiate use for prostate cancer pain;Time to pain progression or opiate use for prostate cancer pain;Time to first use of cytotoxic chemotherapy;Time to first use of new antineoplastic therapy;Time to prostate-specific antigen (PSA) progression;PSA response rates;Time to functional status deterioration as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) global score;Quality of life as assessed by the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) health questionnaire and Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) module | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong Juhn
Novotech Asia Korea
Outcome results
None listed