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

NCT ID: NCT02946996

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-28
• Study Completion Date: 2024-08-19

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin Only

Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

OPC Only

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

Group Type: EXPERIMENTAL

OPC

Intervention Type: OTHER

OPC is a derivative of grape seed extract

Metformin plus OPC

During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.

During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

OPC

Intervention Type: OTHER

OPC is a derivative of grape seed extract

Interventions

Metformin

Intervention Type: DRUG

OPC

OPC is a derivative of grape seed extract

Intervention Type: OTHER

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lilly, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

102508

Identifier Type: -

Identifier Source: org_study_id