Clinical trial NCT00719030: A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy
Official title: A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pomegranate oxidative stress
timeFrame: On day of prostate surgery following 4 weeks of taking POM-X or placebo.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of California, Los Angeles
name: Allan J Pantuck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Medical Center
name: Michael Carducci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Stephen J Freedland, MD
role: PRINCIPAL_INVESTIGATOR
References: