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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Metformin; Other: OPC

• Registration Number: NCT02946996
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-27
• Study Start: 2016-12-28
• Primary Completion: 2023-12-05
• Study Completion: 2024-08-19
• Disposition First Posted: 2024-08-21
• Disposition First Submitted: 2024-11-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Correlation between changes to AGE level and changes to PSA	85 days
Correlation between changes to AGE level and changes to BMI	85 days
Correlations between changes to AGE level and changes to testosterone.	85 days
Correlation between changes to AGE level and changes to A1C.	85 days
Correlation between AGE levels and plasma IL6	85 days
Correlation between AGE levels and oxLDLs (low density lipoprotein)	85 days
Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR)	85 days
Correlation between changes to AGE level and changes to lipids.	85 days
Correlation between changes to AGE level and changes to quality of life	85 days
Correlation between AGE levels and malondialdehyde (MDA)	85 days
Correlation between changes to AGE level and changes to diet.	85 days
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.
Correlation between AGE levels and leptin	85 days
Correlation between AGE levels and c-reactive protein (CRP)	85 days
Correlation between AGE levels and sRAGE (soluble receptor for AGE)	85 days

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States