Titre A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study
Protocole ID PRIME
ClinicalTrials.gov ID NCT03031821
Type(s) de cancer Prostate
Phase Phase III
Stade Maladie avancée ou métastatique
Type étude Support
Médicament Metformine
Institution CIUSSS DE LA MAURICIE-ET-DU-CENTRE-DU-QUEBEC
   CHAUR
      1991 Boulevard du Carmel, Trois-Rivières, QC, G8Z 3R9
Ville Trois-Rivières
Investigateur(trice) principal(e) Dr François Vincent
Coordonnateur(trice) Marie-Ève Caron
 819-697-3333 poste 63238
Statut Fermé
Critètes d'éligibilité
  • Pathologically confirmed adenocarcinoma of the prostate.
  • Eligible for initiating intermittent androgen deprivation therapy with either:
  • Asymptomatic metastatic disease; or
  • Biochemical recurrence of prostate cancer:
  • PSA > 3 ng/mL after prior curative intent local therapy (i.e. prostatectomy); or
  • PSA ≥ 2 ng/mL above their nadir if previously treated with definitive radiotherapy.
  • Serum testosterone > 5 nmol/L.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Protocol treatment is to begin within 7 working days of patient randomization.
Critètes d'exclusion
  • Prior androgen deprivation therapy within 12 months of enrolment.
  • Prior androgen deprivation therapy associated with definitive treatment is permitted, if it has been completed at least 12 months prior to enrolment (i.e. last injection or tablet taken 12 months prior to enrolment).
  • Patients that meet ≥ 1 of the Canadian Diabetes Association criteria for the diagnosis of diabetes within 28 days of enrolment:
  • Fasting plasma glucose of ≥ 7 mmol/L; or
  • HbA1C ≥ 6.5%.
  • Patients currently taking metformin or who have taken metformin within 28 days or enrolment.
  • History of lactic acidosis or conditions that predispose to lactic acidosis:
  • Impaired Renal Function (eGFR < 45 mL/minute/1.73 m2); or
  • Liver disease, including alcoholic liver disease, as demonstrated by any of the following parameters:
  • AST >1.8 x the upper limit of normal
  • ALT > 1.8 x the upper limit of normal
  • Alkaline Phosphatase > 2x the upper limit of normal
  • Serum total bilirubin > 1.5 x the upper limit of normal (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin levels).
  • Alcohol abuse (habitual intake of ≥3 alcoholic beverages per day) sufficient to cause hepatic toxicity; or
  • Severe infection.
  • Congestive heart failure (defined as New York Heart Association Class III or IV functional status).
  • Patients with a history of other invasive malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.