Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin

Exclusion Criteria23

• Metastatic disease (bone, lymph node or other)
• Late radiotherapy urinary or gastrointestinal toxicity (grade ≥ 2) (after radiotherapy of prostate lodge)
• History of cancer in the 5 years prior to trial entry other than cutaneous basal cell carcinoma
• Inflammatory bowel disease
• Contraindications for performing MRI
• Rectal surgery history
• Patient treated for Diabetes
• Creatinine clearance \< 45 mL/min
• Treatment with metformin in the last 3 months prior to inclusion
• Severe comorbidity that may affect treatment, for example :
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of inclusion.
• Unstable angina, myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months
• Myocardial infarction in the last 6 months.
• Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or other respiratory conditions requiring hospitalization or preventing metformin therapy at the time of inclusion.
• Any condition associated with an increased risk of lactic acidosis (e.g., alcohol abuse, New York Heart Association (NYHA) III or IV congestive heart failure).
• Clinically significant history of hepatopathy with Child-Pugh B or C score, including viral infection or hepatitis, alcohol abuse or cirrhosis.
• Any acute or chronic condition that may result in tissue hypoxia (e.g. heart or respiratory failure, shock).
• Bilateral hip prosthesis
• Treatment with any investigational drug or participation in a clinical trial within 30 days prior to inclusion.
• Known hypersensitivity to metformin or any of its components
• Inability or reluctance to swallow oral medications
• Persons deprived of liberty, under a measure of safeguard of justice, under guardianship or under the tutor authority
• Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.