Prostate Cancer
Conditions
Brief summary
The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPomegranate pill
Pomegranate extract pill
DIETARY_SUPPLEMENTPomegranate pill placebo
Pomegranate pill placebo
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pomegranate oxidative stress | On day of prostate surgery following 4 weeks of taking POM-X or placebo. |
Countries
United States
Outcome results
None listed