Stage I Prostate Cancer AJCC v7 Clinical Trial
Official title:
A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
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.
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).
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