Phase 4
N=52
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
Metastatic Castration Resistant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03641560 ↗Enrolled (actual)
52
Serious AEs
19.2%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Treatment- Emergent Adverse Events (TEAEs) — 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Enzalutamide (Drug); Androgen deprivation therapy (ADT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment- Emergent Adverse Events (TEAEs) |
36 | — |
| SECONDARY Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response |
46 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03641560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.