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

April 29, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

41

Phase

  • 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 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPC
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
Drug: Metformin
Other: OPC
OPC is a derivative of grape seed extract

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Correlation between changes to AGE level and changes to PSA
Time Frame: 85 days
85 days
Correlation between changes to AGE level and changes to BMI
Time Frame: 85 days
85 days
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 changes to AGE level and changes to diet.
Time Frame: 85 days
85 days
Correlation between changes to AGE level and changes to quality of life
Time Frame: 85 days
85 days
Frequency of adverse events as assessed by CTCAE v. 4
Time Frame: 85 days
Toxicities will be tabulated per arm by type and grade and the proportion of patients with grade 3, grade 4 or an SAE will be estimated with a 90% confidence interval.
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

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • 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)

December 28, 2016

Primary Completion (Actual)

December 5, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimated)

October 27, 2016

Study Record Updates

Last Update Posted (Estimated)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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