Prostate CancerPhase 1/2NCT03712371
Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients
A Phase 1/2 study testing Chitosan in people with Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Chitosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 7 Sep 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Chitosan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 112 days
Secondary outcomes (7)
Change in Redox Status (RedoxSys, Serum Oxidized Glutathione)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Change in Inflammation (Plasma Cytokines, Toll-like Receptor Signaling)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Change in Insulin Resistance (HOMA-IR)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Changes in Bowel Permeability (Plasma Endotoxin)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Changes in Microbiome Diversity (16s rDNA Sequencing)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Correlate Changes in Serum AGE Levels (Pan-AGE, Carboxymethyllysine, Methylglyoxal
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Measure the Frequency of a > 30% Reduction in Total AGE Levels From the Pretreatment Level.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start16 Jan 2019
- Primary completion2 Jul 2020
- Study completion7 Sep 2021
Why it stopped: Interim study results were not favorable to continue with further enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712371
- Sponsor's protocol ID
- 102928
- Status last verified
- May 2025
- First submitted
- 15 Oct 2018
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03712371
- Acronym / sponsor ID
- 102928
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim study results were not favorable to continue with further enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chitosan Dose Escalation | Experimental | Drug: ChitosanThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Able to swallow and retain oral medication
- ECOG performance status of 0 - 2
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitosanIncreasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days. | Drug | Chitosan Dose Escalation |
Primary outcome
Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity
Time frame: 112 days
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
7 secondary outcomes
Change in Redox Status (RedoxSys, Serum Oxidized Glutathione)
Time frame: 112 days
Change in Inflammation (Plasma Cytokines, Toll-like Receptor Signaling)
Time frame: 112 days
Change in Insulin Resistance (HOMA-IR)
Time frame: 112 days
Changes in Bowel Permeability (Plasma Endotoxin)
Time frame: 112 days
Changes in Microbiome Diversity (16s rDNA Sequencing)
Time frame: 112 days
Correlate Changes in Serum AGE Levels (Pan-AGE, Carboxymethyllysine, Methylglyoxal
Time frame: 112 days
Measure the Frequency of a > 30% Reduction in Total AGE Levels From the Pretreatment Level.
Time frame: 112 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lilly, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chitosan in people with Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.