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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT02946996
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Actual Study Start Date :
Dec 28, 2016
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. AGE level reduction [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.

Secondary Outcome Measures

  1. Correlation between changes to AGE level and changes to PSA [85 days]

  2. Correlation between changes to AGE level and changes to BMI [85 days]

  3. Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR) [85 days]

  4. Correlation between changes to AGE level and changes to A1C. [85 days]

  5. Correlations between changes to AGE level and changes to testosterone. [85 days]

  6. Correlation between changes to AGE level and changes to lipids. [85 days]

  7. Correlation between changes to AGE level and changes to diet. [85 days]

  8. Correlation between changes to AGE level and changes to quality of life [85 days]

  9. Frequency of adverse events as assessed by CTCAE v. 4 [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.

  10. Correlation between AGE levels and plasma IL6 [85 days]

  11. Correlation between AGE levels and leptin [85 days]

  12. Correlation between AGE levels and c-reactive protein (CRP) [85 days]

  13. Correlation between AGE levels and malondialdehyde (MDA) [85 days]

  14. Correlation between AGE levels and oxLDLs (low density lipoprotein) [85 days]

  15. Correlation between AGE levels and sRAGE (soluble receptor for AGE) [85 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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 Cockkroft and Gault formula (see appendix C).

  • Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN

  1. Able to swallow and retain oral medication

  2. ECOG performance status of 0 - 2

  3. Ability to sign written informed consent

  4. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Principal Investigator: Michael Lilly, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02946996
Other Study ID Numbers:
  • 102508
First Posted:
Oct 27, 2016
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022