Prostate Cancer Active Surveillance Metformin Trial

Exclusion Criteria

• •Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues)
• •Diabetes including type 1 diabetes. Patients with known type 2 diabetes are eligible provided they have not been on metformin during the previous 12 months and are not on any other pharmacological agents.
• •Concurrent or previous use of anabolic steroids or drugs with anti androgenic properties including 5-ARIs (dutasteride and finasteride)
• •Prostate volume greater than 80 cc. (as per TRUS biopsy report)
• •Prostatic surgery or procedure within 3 months of screening visit
• •Severe BPH symptoms (IPSS ≥25, or ≥20 if already on α-blocker therapy)
• •Other malignancies, with the exception of adequately treated nonmelanoma skin cancer, NMIBC or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• •Planned or concurrent participation in other interventional randomized trials including exercise
• •The presence of any other coexistent medical condition that in the opinion of the investigator would have the potential to significantly limit adherence to medication, or ability to absorb the medication including but not limited to psychiatric conditions, malabsorption syndromes or severe ischemic heart disease
• •Known hypersensitivity or intolerance to metformin
• •Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or PI3K inhibitors.