To determine the benefit of reduced dose abiraterone as compared to Standard dose in Metastatic Prostate Cancer Patients.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2020/08/026967
- 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
1.Histologically or cytologically confirmed prostate cancer with progressive disease defined as either: Radiographic progression, PSA Progression OR Evidence of castration resistance defined as disease progression despite a testosterone level � 50 ng/dL (or surgical castration)
2.Denosumab or zoledronic acid are allowed
3.ECOG 0,1,2
4.Patients must have normal hepatic function as defined below- a)Total bilirubin < 1.5 x the upper limit of normal b)AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
a)Inability to swallow capsules or gastrointestinal malabsorption
b)Patients who have taken abiraterone in the hormone sensitive prostate cancer (HSPC) setting
c)History of other malignancies with exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or curatively treated solid and hematological tumors with no evidence of disease for � 3 years from enrollment
d)Serum K+ less than 3.5 mmol/L
e)Uncontrolled intercurrent infection or other uncontrolled medical illness
f)Active psychiatric illness which would limit compliance
g)New York Heart Association (NYHA) class II, III or IV heart failure
a.NYHA Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
b.NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20ââ?¬â?100 m). Comfortable only at rest.
c.NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
h)Concurrent therapy with strong inhibitors or inducers of CYP3A4 Use of an investigational product within the prior 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the benefit of reduced dose abiraterone (post prandial state) as compared to Standard dose (fasting state) as assessed by PSA Progression Free Survival (PFS)Timepoint: 5 Years
- Secondary Outcome Measures
Name Time Method 1.To evaluate the effect of reduced dose abiraterone on the PFS & OS. Also, the benefit of reduced dose abiraterone as assessed by Radiological PFS.2.To evaluate the safety profile of reduced dose abiraterone taken in post prandial state 3.To evaluate the difference in the total expenditure of the patient in the two arms 4.Quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireTimepoint: 5 years