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Prostate Cancer Clinical Trial: Effects of Pomegranate Juice or Extract on Rising PSA Levels
Effects of Pomegranate Juice or Extract on Rising PSA Levels in Men Following Primary Therapy for Prostate Cancer
This study is currently recruiting patients. Verified by M.D. Anderson Cancer Center December 2006
Sponsored by:
M.D. Anderson Cancer Center
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00413530
Purpose
Primary Objective:
To compare the effects of daily consumption of pomegranate juice, pomegranate liquid extract, and placebo on end-of-treatment (52 weeks) prostate-specific antigen (PSA) doubling time in male subjects who have rising PSA levels after primary therapy for localized prostate cancer.
Secondary Objectives:
To determine the effect of the pomegranate treatments on the change in PSA doubling time from baseline to end-of-treatment.
To evaluate the effects of the pomegranate treatments on changes in the health-related quality of life (QOL)
To determine the time to tumor recurrence
To assess the tolerability and toxicity of the pomegranate treatments
To determine the effect of the pomegranate treatments on response rates for positive PSA doubling times and for declining post-treatment PSA levels (negative doubling times)
Primary Outcome Variable The primary outcome variable will be the mean PSA doubling time at end-of-treatment.
Secondary Outcome Variables
The secondary outcome variables include:
Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
Overall efficacy responses categorized as, Objective Response (OR): Defined as a decrease of 50% or more in the PSA from baseline level; Progressive Disease (PD): Defined as either: a >100% increase in PSA (with a minimum value of 2.0 ng/mL) from baseline level, or confirmed metastatic or recurrent disease; and Stable Disease (SD): Does not qualify as objective response or progressive disease.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Further study details as provided by M.D. Anderson Cancer Center:
Expected Total Enrollment: 300
Study start: December 2006
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 juice and 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 juice and pomegranate liquid extract. You will be asked to drink 4-ounces (1/2 cup) each of pomegranate juice, 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 roll of dice) to 1 of the 3 study groups (pomegranate juice, pomegranate liquid extract, or placebo). Participants in one group will receive pomegranate juice. Participants in another group will receive pomegranate liquid extract. Participants in another group will receive placebo. There will be a 2 out of 3 chance that you will receive pomegranate juice or 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) of pomegranate juice, 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 juice when you receive your first week's supply. You will continue to drink the study juice for 52 weeks or until your PSA levels do not appear to be responding to the study drink.
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 juice 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 juice each day. You will be given a study-product consumption diary with instructions to record that you drank the juice 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.
You will be taken off this study if there is a change in your health that would require cancer treatment, if your disease gets worse, or if you experience any intolerable side effects from the study drink.
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. The pomegranate juice/extract/placebo and all study procedures will be provided free of charge. Up to 300 participants will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Gleason score of 7 or less
Status post surgery, cryotherapy, or radiation therapy for the primary tumor
Documented rising PSA, including at least one of the following: absolute level of PSA >0.2 ng.mL following surgery; absolute level of PSA >1.0 ng/mL following radiation or cryotherapy; absolute level of PSA >/= 0.4 ng/mL for patients treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.) with 3 rising PSA time points over a minimum of 6 months above the minimum nadir achieved, and the entry PSA must be >/= 100% above the maximum nadir achieved
(Continued from 4) And must have both: minimum of 3 rising PSA time points over a minimum of 6 months to calculate a PSA doubling time for study entry; interval between PSA time points must be > 2 weeks
Performance status 0 or 1 on the ECOG scale
Minimum estimated life expectancy of 6 months
Subject must be eighteen years or older
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) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees no to change/stop during the course of the study
Exclusion Criteria:
Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate
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
Concomitant or antecedent hormonal therapy for rising PSA after initial therapy of prostate cancer
Known allergy to pomegranate juice
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
PSA > 7.0 ng/mL
Histologically positive lymph nodes
PSA doubling time months
Subjects who underwent radical prostatectomy and who never achieved an undetectable serum PSA following surgery
Evident or 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
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
Clinically significant abnormal laboratory value > 2X the upper limit of normal (2XULN)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00413530
Curtis A. Pettaway, MD 713-792-3250
Texas
U.T. M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Curtis A. Pettaway, MD, Principal Investigator
Study chairs or principal investigators
Curtis A. Pettaway, MD, Principal Investigator, U.T. M.D. Anderson Cancer Center
More Information
Study ID Numbers: 2006-0220
Last Updated: December 18, 2006
Record first received: December 15, 2006
ClinicalTrials.gov Identifier: NCT00413530 Health Authority: United States: Institutional Review Board
Concomitant or antecedent hormonal therapy for rising PSA after initial therapy of prostate cancer
Known allergy to pomegranate juice
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
PSA > 7.0 ng/mL
Histologically positive lymph nodes
PSA doubling time months
Subjects who underwent radical prostatectomy and who never achieved an undetectable serum PSA following surgery
Evident or 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
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
Clinically significant abnormal laboratory value > 2X the upper limit of normal (2XULN)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00413530
Curtis A. Pettaway, MD 713-792-3250
Texas
U.T. M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Curtis A. Pettaway, MD, Principal Investigator
Study chairs or principal investigators
Curtis A. Pettaway, MD, Principal Investigator, U.T. M.D. Anderson Cancer Center
More Information
Study ID Numbers: 2006-0220
Last Updated: December 18, 2006
Record first received: December 15, 2006
ClinicalTrials.gov Identifier: NCT00413530 Health Authority: United States: Institutional Review Board
Concomitant or antecedent hormonal therapy for rising PSA after initial therapy of prostate cancer
Known allergy to pomegranate juice
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
PSA > 7.0 ng/mL
Histologically positive lymph nodes
PSA doubling time months
Subjects who underwent radical prostatectomy and who never achieved an undetectable serum PSA following surgery
Evident or 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
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
Clinically significant abnormal laboratory value > 2X the upper limit of normal (2XULN)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00413530
Curtis A. Pettaway, MD 713-792-3250
Texas
U.T. M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Curtis A. Pettaway, MD, Principal Investigator
Study chairs or principal investigators
Curtis A. Pettaway, MD, Principal Investigator, U.T. M.D. Anderson Cancer Center
More Information
Study ID Numbers: 2006-0220
Last Updated: December 18, 2006
Record first received: December 15, 2006
ClinicalTrials.gov Identifier: NCT00413530 Health Authority: United States: Institutional Review Board
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