NCT02095145

Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance

A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression in patients with localized prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the effect of pomegranate fruit extract (PFE) 1000 mg, taken daily for 1 year, on the plasma levels of insulin-like growth factor (IGF-1) from baseline to end of study (52 weeks) in participants undergoing active surveillance (AS) for early stage prostate cancer. SECONDARY OBJECTIVES: I. To assess compliance with a once daily oral administration of PFE versus placebo over a 52-week period of time. II. To assess the toxicity of PFE vs. placebo when taken daily for 52 weeks (+/- 1 week). III. To compare and correlate the effect of 52 weeks of daily dosing with PFE vs placebo on the end of study biopsy results including the presence or absence of tumor, the extent of tumor and Gleason scores. IV. To compare and correlate the modulation of the following biomarkers with response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core, tumor tissue from a positive core, and normal tissue adjacent to tumor from a positive core; plasma: insulin-like growth factor 1/IGF binding protein 3 ratio (IGF-1/IGFBP-3 ratio); prostate tissue (normal and abnormal): apoptosis (CASPASE 3), Ki-67, 8OHdG, IGF-1R, androgen receptor, IGF-1, IGFBP-3, prostate specific antigen (PSA). V. Measure PFE constituents/metabolites in plasma and urine for evidence of accumulation (trough levels): ellagic acid, dimethyl ellagic acid, dimethyl ellagic acid glucuronide (DMEAG), urolithin A, urolithin A-glucuronide, urolithin B and urolithin B-glucuronide. VI. Measure PSA doubling time (PSA DT) in serum, using the calculation provided on the Memorial Sloan Kettering Cancer Center website. VII. To assess the feasibility of cancer chemoprevention trials in a population of men undergoing active surveillance for prostate cancer. VIII. Measurement of serum testosterone. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive pomegranate-extract pill orally (PO) once daily (QD) for 52 weeks (+/- 1 week). GROUP II: Patients receive placebo PO QD for 52 weeks (+/- 1 week).

Conditions

• PSA Level Less Than or Equal to Fifteen
• PSA Level Less Than Ten
• Stage I Prostate Cancer AJCC v7
• Stage II Prostate Cancer AJCC v7
• Stage IIA Prostate Cancer AJCC v7
• Stage IIB Prostate Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Placebo	Given PO
DRUG	Pomegranate-Extract Pill	Given PO

Timeline

• Start date: 2014-05-08
• Primary completion: 2018-01-23
• Completion: 2019-09-26
• First posted: 2014-03-24
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

4 sites across 1 country: United States