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A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy



- Evaluate the effects of pomegranate extract in patients with and rising
prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized
prostate cancer.

- Determine the effect of a daily oral dose of pomegranate extract on the absolute value
of PSA and on the change in PSA doubling time in these patients.


- Assess toxicities associated with daily oral dosing of pomegranate extract in these

- Determine the effect of pomegranate extract on positive PSA doubling-time outcome,
defined as greater than 150% baseline or a negative post-treatment PSA doubling time
(i.e., declining PSA).

OUTLINE: This is a multicenter, double-blind, placebo-controlled, randomized study. Patients
are stratified according to participating center. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral pomegranate extract daily.

- Arm II: Patients receive oral placebo daily. Treatment in both arms continues for up to
1 year in the absence of disease progression.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor

- Documented rising prostate-specific antigen (PSA)

- Absolute level of PSA > 0.2 ng/mL after surgery

- Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy

- Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g.,
surgery with radiotherapy or radiotherapy with cryotherapy)

- PSA must be ≥ 100% above best nadir achieved

- PSA doubling time > 3 months or ≤ 24 months

- Patients must have ≥ 3 rising PSA time points above the minimum nadir
achieved over ≥ 6 months

- The interval between PSA time points must be > 2 weeks

- PSA ≤ 7.0 ng/mL

- Patients who underwent radical prostatectomy and never achieved undetectable serum
PSA after surgery are not eligible

- Gleason score ≤ 7

- No histologically positive lymph nodes

- No evidence of metastatic disease by physical examination, CT scan, or bone scan


- Life expectancy ≥ 6 months

- ECOG performance status 0 or 1

- No significant concomitant medical or psychiatric conditions that would limit study

- No known allergies to pomegranate extract

- No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months

- Diabetic patients entering study who have not had hemoglobin A_1c level measured
in the past 3 months must have levels measured at study initiation

- No clinically abnormal laboratory values > 2 times the upper limit of normal


- See Disease Characteristics

- More than 4 weeks since prior and no concurrent experimental drugs, high-dose
steroids, or other cancer treatment

- No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy
(ADT), prior to or concurrent with primary therapy

- Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150

- No prior or concurrent hormonal therapy for rising PSA after primary therapy for
prostate cancer

- No finasteride or dutasteride at any time point after primary therapy and during
study therapy

- No other concurrent commercial pomegranate products

- No other concurrent systemic or local therapy for prostate cancer

- Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed
provided dose has been stable for ≥ 2 months prior to study entry and there are no
plans to change or stop the supplements during study therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Objective response

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Allan Pantuck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms