A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Interventions
- Drug: Androgen deprivation therapy (ADT)
- Registration Number
- NCT03641560
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
- Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
- Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
- Subject is being newly initiated on Xtandi treatment (Enzalutamide).
- Subject has an estimated life expectancy of ≥ 6 months.
- Subject agrees not to participate in another interventional study while participating in the present study.
- Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
- Subject participating or planning to participate in any interventional drug trial during the course of this trial.
- Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enzalutamide Enzalutamide Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met. Enzalutamide Androgen deprivation therapy (ADT) Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment- Emergent Adverse Events (TEAEs) From first dose of study drug until 30 days after last dose (Up to 1899 days) An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899) Confirmed PSA response rate was defined as the percentage of participants with \>= 50% decline in PSA from baseline to the lowest postbaseline PSA result, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response.
Trial Locations
- Locations (8)
Site IN00003
🇮🇳Nashik, India
Site IN00002
🇮🇳Ahmedabad, India
Site IN00008
🇮🇳Kolkata, India
Site IN00004
🇮🇳Hubli, India
Site IN00010
🇮🇳New Delhi, India
Site IN00001
🇮🇳Pune, India
Site IN00011
🇮🇳Surat, India
Site IN00007
🇮🇳Nashik, India