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

NCT02946996 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 102508
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  85 days

Secondary Outcomes (15)

• Correlation Between Changes to AGE Level and Changes to PSA

  85 days

• Correlation Between Changes to AGE Level and Changes to BMI

  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 A1C.

  85 days

• Correlations Between Changes to AGE Level and Changes to Testosterone.

  85 days

Study Arms (3)

Metformin Only

EXPERIMENTAL

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.

Drug: Metformin

OPC Only

EXPERIMENTAL

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

Other: OPC

Metformin plus OPC

EXPERIMENTAL

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.

Drug: Metformin; Other: OPC

Interventions

Metformin DRUG

Metformin Only; Metformin plus OPC

OPC OTHER

OPC is a derivative of grape seed extract

Metformin plus OPC; OPC Only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
• 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
• Able to swallow and retain oral medication
• ECOG performance status of 0 - 2
• Ability to sign written informed consent
• Testosterone level \<50ng/dL

You may not qualify if:

• Known allergy to grapes or grape seed
• History of receiving more than 2 classes of ADT.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

The study ended early following grant expiration and loss of essential personnel, preventing verification and analysis of collected biospecimens. Several protocol-specified clinical assessments (BMI, diet, quality of life) were not collected due to operational constraints. These limitations significantly restrict interpretation of secondary endpoints and planned correlative analyses.

Results Point of Contact

• Title: Tricia Bentz CTO Administrative Director
• Organization: Medical University of South Carolina

adraleta@musc.edu

8437921415

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 27, 2016
• Study Start: December 28, 2016
• Primary Completion: December 5, 2023
• Study Completion: August 19, 2024
• Last Updated: March 5, 2026
• Results First Posted: February 3, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)