Effect of food on abiraterone in prostate cancer patients
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: null- Metastatic castration resistant prostate cancer
- Registration Number
- CTRI/2018/07/014859
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
1.Patients in age >=18 years
2.Patients with histologically confirmed adenocarcinoma of the prostate
3.Patients with metastatic disease based on a positive bone scan or objective imaging on CT scan
4.mCRPC patients (defined as disease progression despite androgen deprivation therapy i.e., either a luteinizing hormone-releasing hormone agonist or bilateral orchiectomy) who are taking abiraterone 1000 mg for a minimum period of one month.
1.Patients who are not willing to participate and will not provide signed informed consent
2.Uncontrolled DM, defined as HbA1c >=7.5%
3.Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal at baseline
4.Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal
5.Patients with serum potassium less than 3.5 mEq/dl
6.Patients taking CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)
7.Patients taking drugs which are substrates of CYP2D6 (dextromethorphan, thioridazine) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)
8.Autoimmune disease requiring corticosteroid therapy. Active infection or other medical condition that would contraindicate the use of prednisone/prednisolone (corticosteroid)
9.Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
10.Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease
11.Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy
12.Administration of an investigational therapeutic agent within 30 days of screening
13.Prior radiation therapy completed < 4 weeks prior to enrollment
14.Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g., as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that >1 year has passed since the administration of the last chemotherapy dose
15.Any currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next year
16.Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
17.Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated
18.Thyrotoxicosis patients
19.Known brain metastasis
20.History of pituitary or adrenal dysfunction
21.Patients with BMI 18.5 â?? 27.4 kg/m2
22.Patients with lactose intolerance or allergy to milk protein
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method