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

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02946996

Run by

Medical University of South Carolina

People needed

41

Starts

2016-12-28

Expected to finish

2024-08-19

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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