Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients

NCT03712371 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 102928
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the utility of chitosan for reduction of blood or tissue levels of AGEs in patients with prostate cancer who are clinically stable on androgen-deprivation therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity

  The maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn

  112 days

Secondary Outcomes (7)

• Change in Redox Status (RedoxSys, Serum Oxidized Glutathione)

  112 days

• Change in Inflammation (Plasma Cytokines, Toll-like Receptor Signaling)

  112 days

• Change in Insulin Resistance (HOMA-IR)

  112 days

• Changes in Bowel Permeability (Plasma Endotoxin)

  112 days

• Changes in Microbiome Diversity (16s rDNA Sequencing)

  112 days

Study Arms (1)

Chitosan Dose Escalation

EXPERIMENTAL

The starting dose for Chitosan is 500mg twice daily, the second dose level is 1000mg twice daily, the third dose level is 1500mg twice daily and the fourth dose level is 2000mg twice daily. Safety evaluation is 28 days in length and total dose administration is 85 days in length.

Drug: Chitosan

Interventions

Chitosan DRUG

Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days.

Chitosan Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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 Cockgroft and Gault formula
• Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5x ULN
• Able to swallow and retain oral medication
• ECOG performance status of 0 - 2
• Ability to sign written informed consent
• Testosterone level \<50ng/dL at time of enrollment.
• Age 18 or older.
• May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer
• May have had prior cytotoxic chemotherapy for metastatic prostate cancer, prior treatment with genomically-targeted agents, or Provenge

You may not qualify if:

• Known allergy to chitosan or shellfish.
• History of receiving more than 2 classes of ADT.
• Chronic constipation (BM \< 3x weekly), history of malabsorption or history of daily laxative use.
• Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible.
• Current use of chitosan, sevelamer, and/or glucosamine.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Chitosan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Limitations and Caveats

The trial was terminated early due to analysis of AGE assay blood specimens demonstrating a lack of efficacy with the test article. Due to early termination, none of the secondary outcomes were measured.

Results Point of Contact

• Title: Alan Brisendine, CCRP, Manager, Sponsor-Investigator Support Unit
• Organization: Medical University of South Carolina, Hollings Cancer Center, Clinical Trials

brisend@musc.edu

843-792-9007

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: January 16, 2019
• Primary Completion: July 2, 2020
• Study Completion: September 7, 2021
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)