To study whether maintenance treatment with Abiraterone after docetaxel chemotherapy leads to further improvement in metastatic hormone sensitive prostate cancer.
Phase 2
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: N508- Other specified disorders of malegenital organs
- Registration Number
- CTRI/2020/02/023447
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Participants must be hormone sensitive prostate cancer for a histologically confirmed adenocarcinoma of prostate.
2. ECOG performance status <=2.
3. 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 based chemotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For Phase II: <br/ ><br> <br/ ><br>PSA PFS: The interval between randomization and the date of documented progression or death before documented progression or treatment stopped due to any reason. Patients who have not progressed or died at their last follow ups would be censored. <br/ ><br> <br/ ><br>For Phase III: <br/ ><br> <br/ ><br>OS : OS will be defined as time period between date of randomization to date of death due to any cause. Patients alive at their last follow ups would be censored.Timepoint: 5 years
- Secondary Outcome Measures
Name Time Method Toxicity: To compare CTCAE version 4.03 worst grade toxicity between the 2 arms during any period of chemotherapy. <br/ ><br>Overall Quality of Life: The Functional Assessment of Cancer Therapy-Prostate (FACIT-P) is a self report measure of both general and disease specific quality of life. <br/ ><br>Timepoint: 5 years