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Status unknownNCT00732043Updated Mar 16, 2012

Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer

A Phase 2 interventional study of pomegranate extract and pomegranate juice in Prostate Cancer, sponsored by Roll International Corporation. Status unknown at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Roll International Corporation · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.

Read the detailed description

The primary objectives are to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study. Secondary objectives are to determine the effect of the pomegranate treatment on the change in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to determine the effect of the pomegranate treatment on response rates for positive PSA doubling times and for declining post-treatment PSA levels (negative doubling times).

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
  • prostate-specific antigen
  • PSA
  • pomegranate
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 200 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Roll International Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • No evidence of disease progression while on any of the three GUP-0205 study products (disease progression defined as > 100% increase in serum PSA [with a minimum value of 1.0 ng/mL]).
  • Willingness and ability to sign an informed consent document.
  • Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
  • Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) is acceptable provided the dose has been stable during the course of the GUP-0205- 1 study.

Exclusion criteria

Exclusion Criteria:

  • Significant concomitant medical or psychiatric condition that, in the opinion of the Principal Investigator, would put the subject at risk or compromise the protocol.
  • Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
  • Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
  • Subjects unable or unwilling to comply with protocol requirements.
  • Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
  • Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study; at any PSA level, the subject will be excluded if determined by the Principal Investigator that the subject's continued participation would not be in their best interest).
  • Serum PSA doubling time \<13 weeks (assessed at termination of the double-blind study).
  • Evidence of metastatic disease on physical examination or on CT or bone scan.
  • Use of finasteride, dutasteride at any point since primary therapy or during the study.
  • Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2XULN).
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    1

    Dietary Supplement: pomegranate extract

  • Experimental
    2

    Dietary Supplement: pomegranate juice

  • Placebo comparator
    3

    Dietary Supplement: placebo

Interventions

  • Dietary supplementpomegranate extract

    8 oz per day, 48 months

  • Dietary supplementpomegranate juice

    8 oz per day, 48 months

    Also known as: PomWonderful

  • Dietary supplementplacebo

    8 oz per day, 48 months

06

What researchers measure

Primary outcomes

  1. The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.

    Time frame: 48 months

Secondary outcomes

  1. The mean change in PSA doubling time from baseline to end-of-treatment.

    Time frame: 48 months

  2. Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.

    Time frame: 48 months

  3. Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.

    Time frame: 48 months

  4. Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).

    Time frame: 48 months

07

Study locations

1 site
  • UCLA School of Medicine
    Los Angeles, California 90095-1738, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00732043
Lead sponsor
Roll International Corporation
Responsible party
Sponsor
First posted
Aug 11, 2008
Start date
Dec 2007
Primary completion
Jan 2014 (estimated)
Completion
Jan 2015 (estimated)
Last update
Mar 16, 2012

Study contacts

Allan J Pantuck, MD
principal investigator · University of California, Los Angeles
Arie S Belldegrun, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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