NCT03641560CompletedPhase 4
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
A Multicenter Phase 4, Open-label, Single-arm, Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 20 Aug 2018
- Start date
- 19 Sept 2018
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Astellas Pharma Inc
- Diseases
- Prostate cancer
- NCT number
- NCT03641560
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 52
- From 19 Sept 2018 to the primary completion date, 20 Feb 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subject has any condition which makes the subject unsuitable for study participation.
Other
- Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Site IN00002 Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Site IN00004 Coordinator of this site? Confirm its status | Hubli | India | Unknown status |
| Site IN00008 Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Site IN00007 Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Site IN00003 Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Site IN00010 Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Site IN00001 Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Site IN00011 Coordinator of this site? Confirm its status | Surat | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.