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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Androgens; Metformin

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 Cockkroft 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.