A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy

Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
• Radical prostatectomy scheduled at Duke or Johns Hopkins.
• Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
• Age ≥ 18 years of age.
• Willingness and ability to sign an informed consent document.
• Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
• No prior allergy to pomegranate dietary agents.
• No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
• The patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study.
• The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
• Patient has not received experimental medications within the past six months.

Exclusion criteria

• Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate.
• Concomitant or antecedent hormonal therapy.
• Known allergy to pomegranate juice.
• Subjects unable or unwilling to comply with protocol requirements.
• Evidence of metastatic disease on physical examination or on CT or bone scan.
• Use of finasteride, dutasteride at any point during the study.
• Clinically significant abnormal laboratory value >2X the upper limit of normal (2XULN).