Clinical trial NCT03641560: A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Enzalutamide
Xtandi
MDV3100
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
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)
Secondary outcomes:
measure: Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response
timeFrame: Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899)
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Site IN00002
city: Hubli
country: India
facility: Site IN00004
city: Kolkata
country: India
facility: Site IN00008
city: Nashik
country: India
facility: Site IN00003
city: Nashik
country: India
facility: Site IN00007
city: New Delhi
country: India
facility: Site IN00010
city: Pune
country: India
facility: Site IN00001
city: Surat
country: India
facility: Site IN00011
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References: