A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy

Stephen J. Freedland, Michael A Carducci, Nils Kroeger, Alan Wayne Partin, Jian Yu Rao, Yusheng Jin, Susan Kerkoutian, Hong Wu, Yunfeng Li, Patricia Creel, Kelly Mundy, Robin Gurganus, Helen Fedor, Serina A. King, Yanjun Zhang, David Heber, Allan J. Pantuck

Research output: Contribution to journalArticle

Abstract

Pomegranates slow prostate cancer xenograft growth and prolong prostate-specific antigen (PSA) doubling times in single-arm human studies. Pomegranates' effects on human prostate tissue are understudied. We hypothesized that orally administered pomegranate extract (POMx; Pom Wonderful) would lower tissue 8-hydroxy-2′-deoxyguanosine (8-OHdG), an oxidative stress biomarker. Seventy men were randomized to two tablets, POMx or placebo, daily up to four weeks before radical prostatectomy. Tissue was analyzed for intraprostatic urolithin A, a pomegranate metabolite, benign and malignant 8-OHdG, and cancer pS6 kinase, NF-κB, and Ki67. Primary endpoint was differences in 8-OHdG, and the study was powered to detect 35% reduction. POMx was associated with 16% lower benign tissue 8-OHdG (P = 0.095), which was not statistically significant. POMx was well tolerated with no treatment-related withdrawals. There were no differences in baseline clinicopathological features between arms. Urolithin A was detected in 21 of the 33 patients in the POMx group versus 12 of the 35 in the placebo group (P = 0.031). Cancer pS6 kinase, NF-κB, Ki67, and serum PSA changes were similar between arms. POMx before surgery results in pomegranate metabolite accumulation in prostate tissues. Our primary endpoint in this modest-sized short-term trial was negative. Future larger longer studies are needed to more definitively test whether POMx reduces prostate oxidative stress, as well as further animal testing to better understand the multiple mechanisms through which POMx may alter prostate cancer biology.

Original languageEnglish (US)
Pages (from-to)1120-1127
Number of pages8
JournalCancer Prevention Research
Volume6
Issue number10
DOIs
StatePublished - Oct 2013

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Prostatectomy
Punicaceae
Prostatic Neoplasms
Prostate
Prostate-Specific Antigen
Oxidative Stress
Arm
Phosphotransferases
Placebos
Heterografts
Tablets
Neoplasms
Biomarkers
Growth
Serum
3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy. / Freedland, Stephen J.; Carducci, Michael A; Kroeger, Nils; Partin, Alan Wayne; Rao, Jian Yu; Jin, Yusheng; Kerkoutian, Susan; Wu, Hong; Li, Yunfeng; Creel, Patricia; Mundy, Kelly; Gurganus, Robin; Fedor, Helen; King, Serina A.; Zhang, Yanjun; Heber, David; Pantuck, Allan J.

In: Cancer Prevention Research, Vol. 6, No. 10, 10.2013, p. 1120-1127.

Research output: Contribution to journalArticle

Freedland, SJ, Carducci, MA, Kroeger, N, Partin, AW, Rao, JY, Jin, Y, Kerkoutian, S, Wu, H, Li, Y, Creel, P, Mundy, K, Gurganus, R, Fedor, H, King, SA, Zhang, Y, Heber, D & Pantuck, AJ 2013, 'A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy', Cancer Prevention Research, vol. 6, no. 10, pp. 1120-1127. https://doi.org/10.1158/1940-6207.CAPR-12-0423
Freedland, Stephen J. ; Carducci, Michael A ; Kroeger, Nils ; Partin, Alan Wayne ; Rao, Jian Yu ; Jin, Yusheng ; Kerkoutian, Susan ; Wu, Hong ; Li, Yunfeng ; Creel, Patricia ; Mundy, Kelly ; Gurganus, Robin ; Fedor, Helen ; King, Serina A. ; Zhang, Yanjun ; Heber, David ; Pantuck, Allan J. / A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy. In: Cancer Prevention Research. 2013 ; Vol. 6, No. 10. pp. 1120-1127.
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abstract = "Pomegranates slow prostate cancer xenograft growth and prolong prostate-specific antigen (PSA) doubling times in single-arm human studies. Pomegranates' effects on human prostate tissue are understudied. We hypothesized that orally administered pomegranate extract (POMx; Pom Wonderful) would lower tissue 8-hydroxy-2′-deoxyguanosine (8-OHdG), an oxidative stress biomarker. Seventy men were randomized to two tablets, POMx or placebo, daily up to four weeks before radical prostatectomy. Tissue was analyzed for intraprostatic urolithin A, a pomegranate metabolite, benign and malignant 8-OHdG, and cancer pS6 kinase, NF-κB, and Ki67. Primary endpoint was differences in 8-OHdG, and the study was powered to detect 35{\%} reduction. POMx was associated with 16{\%} lower benign tissue 8-OHdG (P = 0.095), which was not statistically significant. POMx was well tolerated with no treatment-related withdrawals. There were no differences in baseline clinicopathological features between arms. Urolithin A was detected in 21 of the 33 patients in the POMx group versus 12 of the 35 in the placebo group (P = 0.031). Cancer pS6 kinase, NF-κB, Ki67, and serum PSA changes were similar between arms. POMx before surgery results in pomegranate metabolite accumulation in prostate tissues. Our primary endpoint in this modest-sized short-term trial was negative. Future larger longer studies are needed to more definitively test whether POMx reduces prostate oxidative stress, as well as further animal testing to better understand the multiple mechanisms through which POMx may alter prostate cancer biology.",
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AU - Mundy, Kelly

AU - Gurganus, Robin

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AU - Pantuck, Allan J.

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