Insulin Resistance and Androgen Deprivation Therapy

NCT ID: NCT04995978

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-01-18

Brief 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.

Detailed 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.

Conditions

Prostate Cancer; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pioglitazone

Group Type: EXPERIMENTAL

Pioglitazone 30 mg

Intervention Type: DRUG

Subjects will self-administer a 30 mg pioglitazone oral tablet daily for 6 months.

For patient taking a diabetic regimen of gemfibrozil, the dose will be 15 mg daily.

placebo

Group Type: PLACEBO_COMPARATOR

placebo tablet

Intervention Type: DRUG

Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.

Interventions

Pioglitazone 30 mg

Subjects will self-administer a 30 mg pioglitazone oral tablet daily for 6 months.

For patient taking a diabetic regimen of gemfibrozil, the dose will be 15 mg daily.

Intervention Type: DRUG

placebo tablet

Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Singh Dhindsa, M.D., F.A.C.E

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Louis Univeristy

St Louis, Missouri, United States

Countries

United States

Other Identifiers

31991

Identifier Type: -

Identifier Source: org_study_id