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

Phase 2TerminatedNCT02946996

Medical University of South Carolina41 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

MetforminDRUG

OPCOTHER

OPC is a derivative of grape seed extract

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 85 days

Secondary Outcomes

Correlation Between Changes to AGE Level and Changes to PSA

To assess whether changes in plasma AGE levels correlate with changes in PSA levels over the 85-day study period

Time frame: 85 days

Correlation Between Changes to AGE Level and Changes to BMI

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.

Time frame: 85 days

Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)

Time frame: 85 days

Correlation Between Changes to AGE Level and Changes to A1C.

Time frame: 85 days

Correlations Between Changes to AGE Level and Changes to Testosterone.

Time frame: 85 days

Correlation Between Changes to AGE Level and Changes to Lipids.

Time frame: 85 days

Data from ClinicalTrials.gov

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