Real world prospective multi-centre study of Low-dose Abiraterone with meals in Indian patients.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034741

Enrollment

250

Registered

2021-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Tab Abiratarone 250 mg ,: Tab abiratarone 250 mg daily metastatic carcinoma of prostate till progression Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Metastatic castrate sensitive prostate cancer Metastatic castrate resistant prostate cancer ECOG â?? PS 0,1,2,3,4

Exclusion criteria

Exclusion criteria: Severe coronary artery disease Uncontrolled hypertension Uncontrolled Diabetes mellitus Metabolic disorders Patients who received Bicalutamide for > 3 months.

Design outcomes

Primary

Measure	Time frame
To study the effect of a lower dose (250mg) of abiraterone acetate in the prandial state. Timepoint: 8 to 12 weeks	—

Secondary

Measure	Time frame
1. To estimate progression-free survival 2. To estimate overall survival 3. To study safety profile of abiraterone acetate. 4. To evaluate the effect of prandial states on the pharmacokinetic properties (TMax, CMax means and variability) 5. To evaluate pharmacodynamic properties (change in extra- gonadal androgen levels), Timepoint: 1 year	—

Countries

India

Contacts

Public ContactAbhishek Pathak

Indian Army

drabhipat@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026