This phase II trial studies how well oligomeric procyanidin complex works in treating patients with prostate cancer receiving androgen deprivation therapy. Oligomeric procyanidin complex may reduce advanced glycation endproduct levels in patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02946996.
PRIMARY OBJECTIVES:
I. To determine if the test agent reduces advanced glycation endproducts (AGE) levels by 30% (or greater) in 50% or more of test subjects
SECONDARY OBJECTIVES:
I. Identify correlations between AGE level changes and baseline, changes in clinical parameters (body mass index [BMI], PSA, insulin resistance [HOMA-IR], A1C, testosterone, lipids, diet) and quality of life measures (American Urological Association [AUA] symptom index, Functional Assessment of Cancer Therapy- Prostate [FACT-P]).
II. Identify toxicities of the test agent in prostate cancer (PCa) subjects.
III. Identify correlations between AGE level changes and baseline, changes in laboratory parameters of inflammation (plasma IL6, leptin, CRP), oxidative stress (malondialdehyde [MDA], oxidized low density lipoproteins [oxLDLs]), and soluble form of receptor for AGE (sRAGE).
IV. Identify the spectrum of protein species that are modified by AGEs, and the changes in levels of these modified proteins to treatment.
OUTLINE:
Patients receive oligomeric procyanidin complex orally (PO) twice daily (BID) in weeks 1-12 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorMichael Brian Lilly
