A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer

Channing Paller, Xiaobu Ye, P. J. Wozniak, B. K. Gillespie, P. R. Sieber, R. H. Greengold, B. R. Stockton, B. L. Hertzman, M. D. Efros, R. P. Roper, H. R. Liker, Michael A Carducci

Research output: Contribution to journalArticle

Abstract

Background:Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.Methods:This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.Results:Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively.CONCLUSIONS:POMx treatment was associated with ≥6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

Original languageEnglish (US)
Pages (from-to)50-55
Number of pages6
JournalProstate Cancer and Prostatic Diseases
Volume16
Issue number1
DOIs
StatePublished - Mar 2013

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Punicaceae
Prostatic Neoplasms
Neoplasm Grading
Therapeutics
Population
Testosterone
Diarrhea
Placebos
Neoplasm Metastasis

Keywords

  • pomegranate
  • PSA recurrence
  • PSADT

ASJC Scopus subject areas

  • Oncology
  • Urology
  • Cancer Research

Cite this

A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer. / Paller, Channing; Ye, Xiaobu; Wozniak, P. J.; Gillespie, B. K.; Sieber, P. R.; Greengold, R. H.; Stockton, B. R.; Hertzman, B. L.; Efros, M. D.; Roper, R. P.; Liker, H. R.; Carducci, Michael A.

In: Prostate Cancer and Prostatic Diseases, Vol. 16, No. 1, 03.2013, p. 50-55.

Research output: Contribution to journalArticle

Paller, Channing ; Ye, Xiaobu ; Wozniak, P. J. ; Gillespie, B. K. ; Sieber, P. R. ; Greengold, R. H. ; Stockton, B. R. ; Hertzman, B. L. ; Efros, M. D. ; Roper, R. P. ; Liker, H. R. ; Carducci, Michael A. / A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer. In: Prostate Cancer and Prostatic Diseases. 2013 ; Vol. 16, No. 1. pp. 50-55.
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abstract = "Background:Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.Methods:This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96{\%} white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.Results:Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P100{\%} of baseline were observed in 43{\%} of patients. Declining PSA levels were observed in 13 patients (13{\%}). In all, 42{\%} of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9{\%} and 13.5{\%} of patients in the 1- and 3-g dose groups, respectively.CONCLUSIONS:POMx treatment was associated with ≥6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.",
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T1 - A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer

AU - Paller, Channing

AU - Ye, Xiaobu

AU - Wozniak, P. J.

AU - Gillespie, B. K.

AU - Sieber, P. R.

AU - Greengold, R. H.

AU - Stockton, B. R.

AU - Hertzman, B. L.

AU - Efros, M. D.

AU - Roper, R. P.

AU - Liker, H. R.

AU - Carducci, Michael A

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N2 - Background:Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.Methods:This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.Results:Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively.CONCLUSIONS:POMx treatment was associated with ≥6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

AB - Background:Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.Methods:This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm.Results:Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively.CONCLUSIONS:POMx treatment was associated with ≥6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

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