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Brief Title: Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin
Official Title: Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin
Study ID: NCT04536805
Brief Summary: 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
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Institut de Cancerologie de L'Ouest, Angers, , France
CHRU de BREST - HOPITAL MORVAN, Brest, , France
Societe de Recherche Oncologique Clinique 37 (Roc 37), Chambray-lès-Tours, , France
Centre GEORGES FRANCOIS LECLERC, Dijon, , France
Clinique Victor Hugo, Le Mans, , France
Centre OSCAR LAMBRET, Lille, , France
Centre LEON BERARD, Lyon, , France
Centre Eugene Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancerologie de L'Ouest, Saint Herblain, , France
ICANS - Institut de cancérologie Strasbourg Europe, Strasbourg, , France
Chru Bretonneau, Tours, , France
Name: Valentine GUIMAS, MD
Affiliation: Institut de Cancérologie de l'Ouest
Role: PRINCIPAL_INVESTIGATOR