Insulin Resistance and Androgen Deprivation Therapy

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Prostate cancer, non-metastatic

• Have been on ADT with long acting GnRH agonist continuously for last 3 months, AND planning to continue ADT for at least 6 months

Exclusion Criteria:

• Used pioglitazone in last 6 months

• Heart Failure NYHA Class 3 or 4

• Known to have osteoporosis at this time.

• history of bladder cancer

• Hemoglobin <8 g/dl

• eGFR <15 ml/min/1.73m2

• liver enzymes (ALT or AST) >3 times the upper limit of normal