Clinical trial · Interventional
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
NCT03641560CI-TRIAL-00115737completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy (ADT) | Drug | — | UNRESOLVED |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzalutamide
- description
- 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.
- interventionNames
- Drug: Enzalutamide
- Drug: Androgen deprivation therapy (ADT)
Primary outcomes (1)
- measure
- Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
- timeFrame
- From first dose of study drug until 30 days after last dose (Up to 1899 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.