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A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Pomegranate Juice or Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Pomegranate Juice or Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer


Some studies suggest that diets with certain plant-based sources (plant chemicals) may help
to reduce the risk of diseases, such as cancer and heart disease.

Pomegranate liquid extract is identical to pomegranate juice, but has a higher concentration
of ingredients that are known to prevent damage to cells.

The placebo used in this study is a juice made by the study sponsor that looks and tastes
like pomegranate liquid extract, but it does not have active ingredients, such as plant
chemicals.

Before beginning screening for this study, you will be checked to make sure you do not have
any allergic reaction to pomegranate liquid extract. You will be asked to drink one 4-ounce
(1/2 cup) sample of pomegranate juice, mixed with pomegranate liquid extract, and placebo.
You will then be watched by the study staff for about 30 minutes. If any signs and symptoms
of allergic reactions are seen, appropriate medical attention will be provided, and you will
not be able to proceed to the screening for this study. If you do not experience any signs
of symptoms of allergic reactions, you will proceed to the screening for this study.

Before you can start on this study, you will have "screening tests." These tests will help
the doctor decide if you are eligible to take part in this study. You will have your
complete medical history recorded. You will have a physical exam, including measurement of
your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and
weight. You will have a digital (insertion by a finger) rectal exam. You will be asked to
complete a food-frequency questionnaire, which will ask about what types of fruits and
vegetables you eat and how often you eat them. It will take about 20 minutes to complete.
You will also have a quality-of-life (QOL) questionnaire that will ask about your health,
activities that might be affected by your health, and/or about pain that you have recently
had. It will take about 15 minutes to complete this questionnaire.

If you have diabetes and have not had your blood sugar levels tested in the past 3 months,
you will have blood drawn (about 1 tablespoon) to check your HbA1c (which will show your
blood sugar levels).

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to 1 of the 2 study groups (pomegranate liquid extract or
placebo). Participants in one group will receive pomegranate liquid extract. Participants in
the other group will receive placebo. There will be a 2 out of 3 chance that you will
receive pomegranate liquid extract.

You will be notified by telephone call about 7 days after your screening visit that you are
eligible to take part in the study. You will also be told the delivery date for your study
juice and a study-product diary.

This is a double-blinded study, which means that neither you nor your doctor or any medical
staff involved in your care, will know which product you receive until the study is
complete. However, the study doctor can find out which product you are receiving (if there
is an emergency or if it is necessary to know for your health).

The study drink will be shipped to M. D. Anderson and then shipped to you directly from M.
D. Anderson. It should be refrigerated immediately when you receive it. You will drink an
8-ounce (1 cup) pomegranate liquid extract or placebo each day (7 days a week) for 52 weeks
(about 1 year). All bottles of the study drink should be refrigerated until you are ready to
drink it. You will receive detailed instructions on how to drink the study drink when you
receive your first week's supply. You will continue to drink the study drink for 52 weeks
or until your PSA levels do not appear to be responding.

A telephone call will be made approximately 7 days after your screening visit. At this
time, you will be informed of your eligibility to participate in the study, and that you
have been randomized. You will be informed of the delivery date for your study drink and a
study-product consumption diary.

During this study, you will be asked to return to the clinic every 13 weeks (Weeks 13, 26,
39, and 52). You will see the research nurse at Weeks 13, 26, and 39, and you will see the
study doctor at Week 52. During these visits, you will have a physical exam, including
measurement of your vital signs and weight. You will be asked if you are taking any
medications. You will have blood drawn (about 3 to 4 teaspoons) and urine collected for
routine tests. You will be asked if you have been drinking the study drink each day. You
will be given a study-product consumption diary with instructions to record that you drank
the drink daily. It will be given to you at each 13-week follow-up visit. You will be asked
not to begin or to stop taking any new nutritional or dietary supplements while you are on
this study so that your supplements do not interfere with the effects of the study drink.

If the disease gets worse while you are on study, you and your study doctor will be able to
find out which study group you were in. If you were taking the placebo, you may be eligible
to enter into another study where you will receive the pomegranate extract for up to 12
months.

During your last study visit (Week 52), you will have a physical exam, including measurement
of your vital signs and weight. You will have a digital rectal exam. You will be asked about
any medications you may be taking. You will have blood drawn (about 3 to 4 teaspoons) and
urine collected for routine tests. You will be asked if you have been drinking the study
drink each day for the last 13 weeks of the study (your consumption diary will be reviewed).
You will be given another food-frequency questionnaire and QOL questionnaire like the ones
that were given during screening.

This is an investigational study. Up to 200 participants will take part in this multicenter
study. Up to 40 will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Histologically confirmed adenocarcinoma of the prostate

2. Status post surgery, cryotherapy, or radiation therapy for the primary tumor

3. Documented rising serum PSA, including at least one of the following: absolute level
of serum PSA >0.2 ng.mL following surgery; absolute level of serum PSA >1.0 ng/mL
following radiation or cryotherapy; absolute level of serum PSA >/= 0.4 ng/mL for
patients treated with multiple treatment modalities (e.g., surgery + radiation,
radiation + cryotherapy, etc.) For the above PSA criteria, there must be 3 rising
serum PSA time points over a minimum of 6 months above the minimum nadir achieved,
and the entry serum PSA must be >/= 100% above the maximum nadir achieved

4. (Continued from 3) And must have both: 3 non-zero serum PSA measurements (including
baseline) that are above the value reported after surgery, radiation cryotherapy or
multiple treatment modalities; interval between seum PSA time points must be > 2
weeks

5. Performance status 0 or 1 on the ECOG scale

6. Minimum estimated life expectancy of 6 months

7. Subject must be eighteen years or older

8. Willingness and ability to sign an informed consent document

9. Agreement with complete abstinence from other commercially available pomegranate
products during the course of the study

10. Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable
provided the dose has been stable for at least 2 months prior to screening and the
subject agrees not to change/stop during the course of the study

Exclusion Criteria:

1. Significant concomitant medical or psychiatric condition that, in the opinion of the
investigator, would make the participant a poor protocol candidate

2. Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy
(ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant
ADT must have a serum testosterone of >150 ng/mL at study entry

3. Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy
of prostate cancer

4. Known allergy to pomegranate juice

5. Subjects unable or unwilling to comply with protocol requirements

6. Prior treatment with experimental drugs, high dose steroids, or with any drugs or
therapy with the potential to impact prostate cancer or PSA within 6 months prior to
the first dose of study product and for the duration of the study

7. Serum PSA > 7.0 ng/mL

8. Serum PSA doubling time months

9. Evidence of metastatic disease on physical examination or on CT or bone scan

10. Use of finasteride, dutasteride at any point since primary therapy or during the
study

11. Diabetes with a known HbA1c level > 7.0% during the past 3 months. Subjects with
diabetes who have not had their HbA1c level measured during the last 3 months will
have it tested at visit 1

12. Clinically significant abnormal laboratory value > 2X the upper limit of normal
(2XULN)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Mean Serum PSA Doubling Time at End-of-treatment

Outcome Description:

Daily consumption of pomegranate liquid extract versus placebo on end-of-treatment (52 weeks) prostate-specific antigen (PSA) doubling time in male subjects who have rising serum PSA levels after primary therapy for localized prostate cancer.

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

Curtis A. Pettaway, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0220

NCT ID:

NCT00413530

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Pomegranate Juice
  • Pomegranate Extract
  • PomWonderful
  • Questionnaire
  • Placebo
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030