Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

The overall goal of this study is to identify a safe dose of the metabolic supplement,
Chitosan that can help reduce AGE (advanced glycation endproducts) levels in patients with
prostate cancer. Chitosan is a naturally occurring substance found in shellfish. This study
will be using Chitosan prepared from the shells of cold-water shrimp. Chitosan is approved by
the FDA for use in wound dressings and has been used in published clinical trials for weight
loss but is not approved for the purposes of this study. AGEs are a type of metabolite, or
substance, found in food and produced in the body. The researchers helping conduct this study
have found a potential link between AGE levels and cancer. Participation in this study will
require three study visits over the course of about 3 months. During these visits subjects
will be asked to provide blood and stool samples as well as complete surveys about their
quality of life.

Inclusion Criteria:

1. Confirmation of adenocarcinoma of the prostate that is documented by one of the
following: pathology report or clinic note with documented history of prostate cancer.

2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an
anti-androgen or testosterone synthesis inhibitor. The current testosterone level must be
documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or
continue on study as long as the testosterone is documented to remain <50ng/dL for the
entire duration of study participation. Subjects who have undergone orchiectomy are also
eligible.

3. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as
follows:

- Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL

- Renal Function: eGFR of ≥ 45mls/min using Cockkroft and Gault formula

- Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5x ULN 4. Able to swallow and
retain oral medication 5. ECOG performance status of 0 - 2 6. Ability to sign written
informed consent 7. Testosterone level <50ng/dL at time of enrollment. 8. Age 18 or
older. 9. May have had prior radiation therapy, surgery, or cryoablation for primary
prostate cancer

1. Known allergy to chitosan or shellfish.

2. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with
genomically-targeted agents, or Provenge is allowed.

3. History of receiving more than 2 classes of ADT.

4. PSA doubling time of <6 months, measured over the 3 months prior to enrollment.

5. Chronic constipation (BM < 3x weekly), history of malabsorption or history of
daily laxative use.

6. Patients requiring medication administration with lunch or dinner or at a
frequency of three or more times per day are not eligible.