Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Abiraterone Acetate: Patient will received 250 mg dose along with low fat meal.
Control Intervention1: Abiraterone Acetate: Patient will received 1000 mg dose in fasting state which is
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 ââ?°Â¥ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Centre
Outcome results
None listed