This phase Ib/II trial studies the side effect and best dose of chitosan in reducing advanced glycation endproducts (AGE) in patients with prostate cancer. Chitosan is a naturally occurring substance found in shellfish that may reduce AGE levels thereby decreasing prostate cancer growth in patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03712371.
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose (MTD) of poliglusam (chitosan) in subjects with prostate cancer (PCa) on androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. To document any systemic effects from the chitosan treatment, related magnitude and timing of AGE depletion to chitosan effects, and determine if chitosan can reduce tissue, as well as serum, AGE levels.
II. Identify systemic effects of chitosan on redox status (RedoxSys, serum oxidized glutathione), inflammation (plasma cytokines, Toll-like receptor signaling), and insulin resistance (homeostatic model assessment-insulin resistance [HOMA-IR]).
III. Determine if chitosan modifies bowel permeability (plasma endotoxin) and microbiome diversity (16s ribosomal deoxyribonucleic acid [rDNA] sequencing).
IV. Correlate changes in serum AGE levels (pan-AGE, carboxymethyllysine, methylglyoxal, pentosidine adducts) with changes in tissue AGE levels as determine by skin autofluorescence.
V. Define the frequency of a >= 30% reduction in total AGE levels from the pretreatment level.
OUTLINE: This is a phase Ib, dose-escalation study followed by a phase II study.
Patients receive poliglusam orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorMichael Brian Lilly
