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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
OPC
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPC

Arm Description

Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.

Outcomes

Primary Outcome Measures

AGE level reduction
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.

Secondary Outcome Measures

Correlation between changes to AGE level and changes to PSA
Correlation between changes to AGE level and changes to BMI
Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR)
Correlation between changes to AGE level and changes to A1C.
Correlations between changes to AGE level and changes to testosterone.
Correlation between changes to AGE level and changes to lipids.
Correlation between changes to AGE level and changes to diet.
Correlation between changes to AGE level and changes to quality of life
Frequency of adverse events as assessed by CTCAE v. 4
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.
Correlation between AGE levels and plasma IL6
Correlation between AGE levels and leptin
Correlation between AGE levels and c-reactive protein (CRP)
Correlation between AGE levels and malondialdehyde (MDA)
Correlation between AGE levels and oxLDLs (low density lipoprotein)
Correlation between AGE levels and sRAGE (soluble receptor for AGE)

Full Information

First Posted
October 18, 2016
Last Updated
July 17, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02946996
Brief Title
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official Title
Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OPC
Arm Type
Experimental
Arm Description
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Other
Intervention Name(s)
OPC
Intervention Description
OPC is a derivative of grape seed extract
Primary Outcome Measure Information:
Title
AGE level reduction
Description
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.
Time Frame
85 days
Secondary Outcome Measure Information:
Title
Correlation between changes to AGE level and changes to PSA
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to BMI
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR)
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to A1C.
Time Frame
85 days
Title
Correlations between changes to AGE level and changes to testosterone.
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to lipids.
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to diet.
Time Frame
85 days
Title
Correlation between changes to AGE level and changes to quality of life
Time Frame
85 days
Title
Frequency of adverse events as assessed by CTCAE v. 4
Description
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.
Time Frame
85 days
Title
Correlation between AGE levels and plasma IL6
Time Frame
85 days
Title
Correlation between AGE levels and leptin
Time Frame
85 days
Title
Correlation between AGE levels and c-reactive protein (CRP)
Time Frame
85 days
Title
Correlation between AGE levels and malondialdehyde (MDA)
Time Frame
85 days
Title
Correlation between AGE levels and oxLDLs (low density lipoprotein)
Time Frame
85 days
Title
Correlation between AGE levels and sRAGE (soluble receptor for AGE)
Time Frame
85 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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, 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. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed. 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 Able to swallow and retain oral medication ECOG performance status of 0 - 2 Ability to sign written informed consent Testosterone level <50ng/dL Exclusion Criteria Known allergy to grapes or grape seed History of receiving more than 2 classes of ADT. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Brisendine
Phone
843-792-9007
Email
brisend@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmin Brooks
Email
brooksjm@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lilly, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Wheeler
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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