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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Pomegranate oxidative stress

Outcome Time Frame:

On day of prostate surgery following 4 weeks of taking POM-X or placebo.

Safety Issue:


Principal Investigator

Allan J Pantuck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

April 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Duke University Medical Center Durham, North Carolina  27710
UCLA Los Angeles, California  90095