The study of compairing benefit of Abiraterone low versus full dose with Docetaxel in Prostate Cancer
Phase 3
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2023/03/050180
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
participants must be hormone sensitive prostrate cancer.
Age above 18 years
ECOG permance status <2
participants must have normal organ and marrow function
Exclusion Criteria
1.participants who are receiving any other investigational agents.
2.participants who are designated as unfit for receiving Abiraterone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the non inferiority of low dose abiraterone 250mg with low fat meal compared to hogh dose abiraterone 1000mg with in fasting state to improve 3 year PSA PFS in patients with hormone sensitive metastatic prostate cancer receiving Androgen deprivation therapy+docetaxel chemotherapyTimepoint: 3 year
- Secondary Outcome Measures
Name Time Method 1. OS <br/ ><br>2.Toxicity <br/ ><br>3.QOLTimepoint: 3 years