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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719030
• Other study ID #: GUP-0515-02
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: July 28, 2016
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2014
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Pomegranate pill
Pomegranate extract pill
• Pomegranate pill placebo
Pomegranate pill placebo

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pomegranate oxidative stress		On day of prostate surgery following 4 weeks of taking POM-X or placebo.	No