Insulin Resistance and Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

Official title: Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy

Status Withdrawn

Clinical Trial Summary

Prostate cancer is the most common malignancy amongst men in United States. Androgen deprivation therapy (ADT) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. Since ADT induces insulin resistance and diabetes, it is important that cellular and molecular effects of ADT are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. Pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.

Clinical Trial Description

Investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving ADT with long acting GnRH agonist (study group). Study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. They will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. Blood samples will be drawn 2 and 4 months following the initiation of the study drug. The final study visit will be at 6 months. Subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study. ;

Related Conditions & MeSH terms

• Insulin Resistance
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04995978
• Study type: Interventional
• Source: St. Louis University
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2021
• Completion date: January 18, 2023