drugset / Trial / NCT02614859

Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients

NCT02614859

Phase 2 Completed 29 enrolled Fox Chase Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer.

Timeline

Start
2015-12-01
Primary completion
2020-01-24
Completion
2020-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicalutamide Other / unclassified 50 mg Oral
Subject Metformin Small molecule 1000 mg

Indications