Health Condition 1: C60-C63- Malignant neoplasms of male genital organs
Conditions
Interventions
Intervention1: Enzalutamide: 160 mg administered orally, once daily
Study drug is to be taken until disease progression, unacceptable toxicity or any other discontinuation criteria are met.
Control I
Sponsors
Astellas Pharma Inc API
Eligibility
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board Independent Ethics Committee -approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures including withdrawal of prohibited medication, if applicable 2. Subject is 18 years or more at the time of signing informed consent. 3. Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. 4. Subject with established diagnosis of metastatic castration-resistant prostate carcinoma. 5. Being newly initiated on Xtandi treatment Enzalutamide based on independent clinical judgment of treating physicians as per locally approved prescribing information. 6. Subject has an estimated life expectancy of = 6 months as assessed by the Investigator. 7. A sexually active male subject with female partners who are of childbearing potential is eligible if a. Agree to use a male condom starting at screening and continue throughout study treatment and for 3 months after the final study drug administration. b. If the male subject has not had a vasectomy or is not sterile as defined below their female partner is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment and for 3 months after the final study drug administration. c. Consistent and correct usage of established hormonal contraceptives that inhibit ovulation, d. Established intrauterine device or intrauterine system e. Bilateral tubal occlusion f. Vasectomy A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used g. Male is sterile due to a bilateral orchiectomy h. Sexual Abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant 8. Male subject with a pregnant or breastfeeding partner must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 3 months after the final study drug administration. 9. Male subject must not donate sperm starting at screening and throughout the study period, and for 3 months after the final study drug administration. 10. Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
Exclusion criteria: 1. Subject who is not eligible to receive Xtandi as per the locally approved prescribing information. 2. Subject participating or planning to participate in any interventional drug trial during the course of this trial. 3. Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening. 4. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. Timepoint: Till Death | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of enzalutamide on prostate specific antigen.Timepoint: Till Death | — |
Countries
India
Contacts
Public ContactNivedita Nimonkar
Astellas Pharma India Pvt. Ltd.
Outcome results
None listed