J Cancer 2013; 4(7):597-605. doi:10.7150/jca.7123

Research Paper

Daily Pomegranate Intake Has No Impact on PSA Levels in Patients with Advanced Prostate Cancer - Results of a Phase IIb Randomized Controlled Trial

Frank Stenner-Liewen1, Heike Liewen1*, Richard Cathomas2*, Christoph Renner1, Ulf Petrausch1, Tullio Sulser3, Katharina Spanaus4, Hans Helge Seifert5, Räto Thomas Strebel6, Alexander Knuth1, Panagiotis Samaras1†, Michael Müntener3† ✉

1. Department of Oncology, University Hospital Zürich, Switzerland;
2. Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland;
3. Department of Urology, University Hospital Zürich, Switzerland;
4. Institute of Clinical Chemistry, University Hospital Zürich, Switzerland.
5. Department of Urology, Hospital Hegau-Bodensee, Germany.
6. Department of Urology, Kantonsspital Graubünden, Chur, Switzerland.
* contributed equally to this article.
† share senior authorship.

Abstract

Pomegranate has been shown to prolong PSA doubling time in early prostate cancer, but no data from a placebo controlled trial has been published yet. The objective of this study was to prospectively evaluate the impact of pomegranate juice in patients with prostate cancer.

We conducted a phase IIb, double blinded, randomized placebo controlled trial in patients with histologically confirmed prostate cancer. Only patients with a PSA value ≥ 5ng/ml were included. The subjects consumed 500 ml of pomegranate juice or 500 ml of placebo beverage every day for a 4 week period. Thereafter, all patients received 250 ml of the pomegranate juice daily for another 4 weeks. PSA values were taken at baseline, day 14, 28 and on day 56. The primary endpoint was the detection of a significant difference in PSA serum levels between the groups after one month of treatment. Pain scores and adherence to intervention were recorded using patient diaries.

102 patients were enrolled. The majority of patients had castration resistant prostate cancer (68%). 98 received either pomegranate juice or placebo between October 2008 and May 2011. Adherence to protocol was good, with 94 patients (96%) completing the first period and 87 patients (89%) completing both periods. No grade 3 or higher toxicities occurred within the study. No differences were detected between the two groups with regard to PSA kinetics and pain scores.

Consumption of pomegranate juice as an adjunct intervention in men with advanced prostate cancer does not result in significant PSA declines compared to placebo.

Keywords: Pomegranate juice, PSA, prostate cancer, nutraceutical, ellagig acids, polyphenols.

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How to cite this article:
Stenner-Liewen F, Liewen H, Cathomas R, Renner C, Petrausch U, Sulser T, Spanaus K, Seifert HH, Strebel RT, Knuth A, Samaras P, Müntener M. Daily Pomegranate Intake Has No Impact on PSA Levels in Patients with Advanced Prostate Cancer - Results of a Phase IIb Randomized Controlled Trial. J Cancer 2013; 4(7):597-605. doi:10.7150/jca.7123. Available from http://www.jcancer.org/v04p0597.htm