Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

February 13, 2026 updated by: Medical University of South Carolina

Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  4. 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 (see appendix C).
    • Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN
  5. Able to swallow and retain oral medication
  6. ECOG performance status of 0 - 2
  7. Ability to sign written informed consent
  8. Testosterone level <50ng/dL

Exclusion Criteria

  1. Known allergy to grapes or grape seed
  2. History of receiving more than 2 classes of ADT.
  3. Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more details.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metformin Only
Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.
Drug: Metformin
Experimental: OPC Only
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
Other: OPC
OPC is a derivative of grape seed extract
Experimental: Metformin plus OPC

During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.

During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
Drug: Metformin
Other: OPC
OPC is a derivative of grape seed extract

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AGE Level Reduction
Time Frame: 85 days
The primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
85 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)
Time Frame: 85 days
85 days
Correlation Between Changes to AGE Level and Changes to A1C.
Time Frame: 85 days
85 days
Correlations Between Changes to AGE Level and Changes to Testosterone.
Time Frame: 85 days
85 days
Correlation Between Changes to AGE Level and Changes to Lipids.
Time Frame: 85 days
85 days
Correlation Between AGE Levels and Plasma IL6
Time Frame: 85 days
85 days
Correlation Between AGE Levels and Leptin
Time Frame: 85 days
85 days
Correlation Between AGE Levels and C-reactive Protein (CRP)
Time Frame: 85 days
85 days
Correlation Between AGE Levels and Malondialdehyde (MDA)
Time Frame: 85 days
85 days
Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein)
Time Frame: 85 days
85 days
Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE)
Time Frame: 85 days
85 days
Correlation Between Changes to AGE Level and Changes to PSA
Time Frame: 85 days
To assess whether changes in plasma AGE levels correlate with changes in PSA levels over the 85-day study period
85 days
Correlation Between Changes to AGE Level and Changes to BMI
Time Frame: 85 days
This outcome was intended to evaluate whether changes in plasma AGE levels from baseline to Day 85 correlated with changes in body mass index (BMI), planned for Screening, Day 1, and Day 85. Although this measure was protocol-specified, BMI assessments were never initiated because clinical research personnel responsible for baseline and follow-up measurements departed early in the study period, before any participants reached these scheduled assessment points. After this loss of personnel, the study team no longer had qualified staff to perform BMI measurements, and retrospective collection was not possible. As a result, no BMI data were collected for any participants.
85 days
Correlation Between Changes to AGE Level and Changes to Diet
Time Frame: 85 days
This outcome aimed to determine whether changes in plasma AGE levels correlated with changes in dietary intake, assessed using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan" at baseline and Day 85. Although protocol-specified, these instruments were never administered because essential study personnel who were responsible for conducting participant-reported assessments left the study before any questionnaire sessions occurred. After staff departure, the study team lacked the resources required to administer or score the diet questionnaires, and no alternative personnel were available. As a result, no dietary intake data were collected, and no analyses could be performed.
85 days
Correlation Between Changes to AGE Level and Changes to Quality of Life
Time Frame: 85 days
This outcome sought to evaluate whether changes in plasma AGE levels correlated with changes in quality of life, assessed with the FACT-P and AUA Symptom Index at baseline and Day 85. Although these assessments were included in the protocol, they were never initiated because the study personnel responsible for administering participant-reported questionnaires departed before any QOL data collection sessions were conducted. After the loss of staff, the study team did not have qualified personnel to administer, process, or score QOL instruments, making further collection infeasible. Consequently, no QOL data were collected for any participants.
85 days
Frequency of Adverse Events as Assessed by CTCAE v. 4
Time Frame: 85 days
To assess the frequency and severity of adverse events associated with study drug administration, categorized by CTCAE v4 criteria.
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Lilly, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 102508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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