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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02946996
• Other study ID #: 102508
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 28, 2016
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: May 31, 2024
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Metformin

Other:
• OPC
OPC is a derivative of grape seed extract

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between changes to AGE level and changes to PSA		85 days
Secondary	Correlation between changes to AGE level and changes to BMI		85 days
Secondary	Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR)		85 days
Secondary	Correlation between changes to AGE level and changes to A1C.		85 days
Secondary	Correlations between changes to AGE level and changes to testosterone.		85 days
Secondary	Correlation between changes to AGE level and changes to lipids.		85 days
Secondary	Correlation between changes to AGE level and changes to diet.		85 days
Secondary	Correlation between changes to AGE level and changes to quality of life		85 days
Secondary	Frequency of adverse events as assessed by CTCAE v. 4	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.	85 days
Secondary	Correlation between AGE levels and plasma IL6		85 days
Secondary	Correlation between AGE levels and leptin		85 days
Secondary	Correlation between AGE levels and c-reactive protein (CRP)		85 days
Secondary	Correlation between AGE levels and malondialdehyde (MDA)		85 days
Secondary	Correlation between AGE levels and oxLDLs (low density lipoprotein)		85 days
Secondary	Correlation between AGE levels and sRAGE (soluble receptor for AGE)		85 days