NCT01823562

Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

Dietary Fruit Bioactives and Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.

Detailed description

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 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 PO daily for 4-6 weeks and then undergo prostatectomy.

Conditions

• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Interventions

Type	Name	Description
DRUG	lyophilized black raspberry confection	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
DIETARY_SUPPLEMENT	dietary intervention	Follow a low polyphenol diet
DIETARY_SUPPLEMENT	dietary intervention	Follow a low ellagitannin diet
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2012-10-17
• Primary completion: 2013-08-01
• Completion: 2025-06-01
• First posted: 2013-04-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study