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

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ClinicalTrials.gov Identifier: NCT02946996
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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
Prostate Cancer Drug: Metformin Other: OPC 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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 : December 28, 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Correlation between changes to AGE level and changes to PSA [ Time Frame: 85 days ]
  2. Correlation between changes to AGE level and changes to BMI [ Time Frame: 85 days ]
  3. Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR) [ Time Frame: 85 days ]
  4. Correlation between changes to AGE level and changes to A1C. [ Time Frame: 85 days ]
  5. Correlations between changes to AGE level and changes to testosterone. [ Time Frame: 85 days ]
  6. Correlation between changes to AGE level and changes to lipids. [ Time Frame: 85 days ]
  7. Correlation between changes to AGE level and changes to diet. [ Time Frame: 85 days ]
  8. Correlation between changes to AGE level and changes to quality of life [ Time Frame: 85 days ]
  9. 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.

  10. Correlation between AGE levels and plasma IL6 [ Time Frame: 85 days ]
  11. Correlation between AGE levels and leptin [ Time Frame: 85 days ]
  12. Correlation between AGE levels and c-reactive protein (CRP) [ Time Frame: 85 days ]
  13. Correlation between AGE levels and malondialdehyde (MDA) [ Time Frame: 85 days ]
  14. Correlation between AGE levels and oxLDLs (low density lipoprotein) [ Time Frame: 85 days ]
  15. Correlation between AGE levels and sRAGE (soluble receptor for AGE) [ Time Frame: 85 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946996


Contacts
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Contact: Mike Wheeler 843-792-9321 hcc-clinical-trials@musc.edu
Contact: Michael Lilly, MD 843-792-4271 lillym@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Mike Wheeler    843-792-9321    hcc-clinical-trials@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Michael Lilly, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02946996     History of Changes
Other Study ID Numbers: 102508
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists