Pioglitazone and Insulin Resistance in ADT
Prostate Cancer, Insulin Resistance, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Male, age ≥18 years of age.
- Body Mass Index of > 25 kg/m2
- Biopsy-confirmed prostate adenocarcinoma currently on androgen deprivation therapy (ADT) for minimum of 3 months for the ADT group and biopsy-confirmed prostate adenocarcinoma not on ADT for control group
5. Hemoglobin > 11 g/dL, Creatinine < 1.5x ULN and liver function tests < 2x ULN 6. Participant must be able to read, write, and understand the English language and be able to provide written consent 7. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Known clinically significant severe COPD, ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
- Any patient with known diabetes (A1c > 6.4%) or an anti-diabetic drug
- Any condition contraindicating additional blood collection beyond standard of care
- Subjects with known allergy to lidocaine (this is used to anesthetize area for fat biopsy)
- Subjects with known allergy to pioglitazone or other thiazolidinediones
- Subjects with pioglitazone use in last 6 months
- Subjects with congestive Heart Failure Class 3 or 4
- Subjects with osteoporosis, including history of fragility fracture
- Subjects with history of bladder cancer
- Subjects on chronic use of androgens, or opiates in the last 6 months or with panhypopituitarism, congenital HH (hypogonadotropic hypogonadism), prolactinoma, head trauma
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo study procedures.
Sites / Locations
- Diabetes and Endocrinology Research Center of WNY
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
No Intervention
Prostate cancer on ADT receiving pioglitazone
Prostate cancer on ADT receiving placebo
Prostate cancer not on ADT
Subjects will receive a 12-week supply of pioglitazone 30 mg dose 1 tab daily
Subjects will receive a 12 week supply of placebo pills containing cellulose
No intervention will be done in this group