Status and phase
Conditions
Treatments
About
This phase I/II escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation (SBRT) of relapses within the prostatectomy bed, potentiated by metformin
Full description
The purpose of this escalation study is, first to select the recommended dose of re-irradiation SBRT in combination with Metformin (based on treatment toxicity monitoring) and then to estimate the efficacy of re-irradiation SBRT in combination with Metformin.
Five or six fractions, at a level of 5 or 6 Gray (Gy) per session (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy), will be delivered over a maximum of 12 days (from day 1 to day 10 or 12) to provide a total dose of 25 to 36 Gy.
Patient receive oral Metformin treatment from Day -15 and Day 75.
Patient will be followed for 5 years: patients visits will be planned at week 2; 4; 8; 12; and month M6; M9; M12; M18; M24; M36; 4 years and 5 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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 :
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.
Primary purpose
Allocation
Interventional model
Masking
44 participants in 3 patient groups
Loading...
Central trial contact
Valentine GUIMAS, MD; Nadia ALLAM, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal