Dietary Fruit Bioactives and Prostate Cancer
PRIMARY OBJECTIVES:
I. To conduct a dose-escalation study to determine safety and compliance of varying
lyophilized black raspberry (LBR) delivery vehicles (a gummy confection and a nectar) at two
different doses.
SECONDARY OBJECTIVES:
I. To precisely quantify changes in the content and distribution of black raspberry
phytochemicals and their metabolites in the blood and urine and correlate these
concentrations with prostate tissue phytochemicals.
II. Measure the ability of black raspberry gummy confection and nectar in altering hormonal
patterns (lower insulin-like growth factor-1 [IGF-I], higher insulin-like growth
factor-binding protein 3 [IGF-BP3], lower androgens) consistent with reduced prostate
carcinogenesis and in parallel with an enhanced capacity to quench reactive oxygen.
III. Investigate histopathologic, immunologic, and molecular biomarkers associated with
prostate carcinogenesis that may serve as surrogate endpoint biomarkers and provide
information regarding their ability to be modulated by black raspberries.
IV. Determine if consumption of black raspberries alters molecular markers in the human
prostate including: (a) neuroendocrine markers such as IGF-I and IGF-BP3, (b) signal
transduction markers such as phosphatase and tensin homologue (PTEN) and phospho-AKT, and
(c) angiogenesis regulators such as (vascular epithelial growth factor (VEGF).
V. Collect and store plasma and peripheral blood mononuclear cells (PBMCs) from each patient
to assess systemic markers of inflammation and immune response.
OUTLINE: This is a dose-escalation study of lyophilized black raspberry gummy confection and
nectar. Patients are assigned to 1 of 7 treatment arms.
ARM I: Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
ARM II: Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
ARM III: Patients follow a low ellagitannin diet for 4-6 weeks and then undergo
prostatectomy.
ARM IV: Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy
orally (PO) daily for 4-6 weeks and then undergo prostatectomy.
ARM V: Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy
PO daily for 4-6 weeks and then undergo prostatectomy.
ARM VI: Patients follow a low ellagitannin diet and receive lower-dose black raspberry
nectar confection PO daily for 4-6 weeks and then undergo prostatectomy.
ARM VII: Patients follow a low ellagitannin diet and receive higher-dose black raspberry
nectar confection PO daily for 4-6 weeks and then undergo prostatectomy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Up to 30 days after completion of study treatment
Yes
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
OSU-12125
NCT01823562
October 2012
Name | Location |
---|---|
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |