Clinical trial

Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy

Name
31991
Description
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.
Trial arms
Trial start
2021-12-01
Estimated PCD
2023-01-18
Trial end
2023-01-18
Status
Withdrawn
Phase
Early phase I
Treatment
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.
Arms:
Pioglitazone
placebo tablet
Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.
Arms:
placebo
Primary endpoint
insulin sensitivity
6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-06-23

1 organization

2 products

2 indications

Indication
Prostate Cancer
Product
Placebo