A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate, without evidence of spread
beyond to lymph nodes, bone, or visceral organs.

2. Radical prostatectomy scheduled at Duke or Johns Hopkins.

3. Initial prostate biopsy available for review with tumor involving 2 or more core
biopsies based on pathologic review.

4. Age ≥ 18 years of age.

5. Willingness and ability to sign an informed consent document.

6. Agreement with complete abstinence from other commercially available pomegranate
products during the course of the study.

7. No prior allergy to pomegranate dietary agents.

8. No significant medical or psychiatric condition that would make the patient a poor
protocol candidate.

9. 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.

10. The patient is not taking LHRH agonists, androgen receptor blocking agents or
finasteride, and has not undergone bilateral orchiectomy.

11. Patient has not received experimental medications within the past six months.

Exclusion Criteria:

1. Significant concomitant medical or psychiatric condition that, in the opinion of the
investigator, would make the participant a poor protocol candidate.

2. Concomitant or antecedent hormonal therapy.

3. Known allergy to pomegranate juice.

4. Subjects unable or unwilling to comply with protocol requirements.

5. Evidence of metastatic disease on physical examination or on CT or bone scan.

6. Use of finasteride, dutasteride at any point during the study.

7. Clinically significant abnormal laboratory value >2X the upper limit of normal
(2XULN).