Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Vitamin K2: Vitamin K2 is a naturally occurring form of vitamin K and is an approved drug in India. Vitamin K2 100 mcg will be administered in oral capsule formulation once daily for a
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age=18 years 2. Biopsy proven prostate cancer patients on ADT
Exclusion criteria
Exclusion criteria: a. Patients who are not willing to participate and will not provide signed informed consent b. Patients with gastrointestinal disorders such as peptic ulcer disease c. History of hematemesis, hemoptysis, melena or hematuria d. Patients with bleeding diathesis e. Patients with connective tissue disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis and other autoimmune disorders f. History of any bone fracture or metabolic bone disease or bone tumor g. Use of any anticoagulant or warfarin h. Thyrotoxicosis patients i. 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 j. Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal k. Patients with congestive cardiac failure, severe or unstable angina l. Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy m. Administration of an investigational therapeutic agent within 30 days of screening n. Prior radiation therapy completed o. 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 p. Active psychiatric illnesses/social situations that would limit compliance with protocol requirements q. Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated r. Visceral metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density measured by DEXATimepoint: Day 1 and at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Levels of following vitamin K dependent markers in serum using ELISA a) Undercarboxylated osteocalcin (ucOC) b) Total osteocalcin (OC) c) Ratio of OC and ucOC 2. Subgroup analysis to compare bone mineral density measured with DEXA scan in following two subgroups of prostate cancer patients I. with bone metastasis II. without bone metastasis Timepoint: Day 1 and day 365 | — |
Countries
India
Contacts
Public ContactAmlesh Seth
AIIMS, New Delhi
Outcome results
None listed