Clinical trial NCT02946996: Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official title: Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AGE Level Reduction
timeFrame: 85 days
Secondary outcomes:
measure: Correlation Between Changes to AGE Level and Changes to PSA
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to BMI
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to A1C.
timeFrame: 85 days
measure: Correlations Between Changes to AGE Level and Changes to Testosterone.
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to Lipids.
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to Diet.
timeFrame: 85 days
measure: Correlation Between Changes to AGE Level and Changes to Quality of Life
timeFrame: 85 days
measure: Frequency of Adverse Events as Assessed by CTCAE v. 4
timeFrame: 85 days
measure: Correlation Between AGE Levels and Plasma IL6
timeFrame: 85 days
measure: Correlation Between AGE Levels and Leptin
timeFrame: 85 days
measure: Correlation Between AGE Levels and C-reactive Protein (CRP)
timeFrame: 85 days
measure: Correlation Between AGE Levels and Malondialdehyde (MDA)
timeFrame: 85 days
measure: Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein)
timeFrame: 85 days
measure: Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE)
timeFrame: 85 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Lilly, MD
role: PRINCIPAL_INVESTIGATOR
References: