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Effects of Pomegranate Juice or Extract on Rising PSA Levels in Men Following Primary Therapy for Prostate Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
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:

  1. To determine the effect of the pomegranate treatments on the change in PSA doubling time from baseline to end-of-treatment.
  2. To evaluate the effects of the pomegranate treatments on changes in the health-related quality of life (QOL)
  3. To determine the time to tumor recurrence
  4. To assess the tolerability and toxicity of the pomegranate treatments
  5. 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:

  1. Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
  2. Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
  3. 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.
  4. RAND 36-item Health Survey to assess QOL
  5. Biomarker occurrences may be evaluated.

Condition Intervention
Prostate Cancer
Drug: Pomegranate Juice
Other: Placebo
Behavioral: Questionnaire

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), 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:

Primary Outcome Measures:
  • To compare the effects of daily consumption of pomegranate liquid extract and placebo on end-of-treatment PSA doubling time in male subjects who have rising PSA levels after primary therapy for localized prostate cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of the pomegranate treatments on the change in PSA doubling time from baseline to end-of-treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Pomegranate liquid extract
Drug: Pomegranate Juice
Subjects will orally receive 8 ounces of pomegranate liquid extract (equivalent to 1.6 mmol of total polyphenols per day) or matching placebo daily.
Behavioral: Questionnaire
Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
2: Placebo Comparator
Matching placebo juice
Other: Placebo
Subjects will orally receive 8 ounces of pomegranate liquid extract (equivalent to 1.6 mmol of total polyphenols per day) or matching placebo daily.
Behavioral: Questionnaire
Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. Status post surgery, cryotherapy, or radiation therapy for the primary tumor
  3. 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
  4. (Continued from 3) And must have both: 3 non-zero PSA measurements (including baseline) that are above the value reported after surgery, radiation cryotherapy or multiple treatment modalities; interval between 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 cannot have a serum testosterone of </= 150 ng/mL at study entry
  3. Concomitant or antecedent hormonal therapy for rising 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 other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study
  7. PSA > 7.0 ng/mL
  8. PSA doubling time </= 3 months or 24 > 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413530

Contacts
Contact: Curtis A. Pettaway, MD 713-792-3250

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Curtis A. Pettaway, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Curtis A. Pettaway, MD U.T. M.D. Anderson Cancer Center
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: U.T. M.D. Anderson Cancer Center ( Curtis A. Pettaway, MD,BS/Professor )
Study ID Numbers: 2006-0220
Study First Received: December 15, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00413530  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Pomegranate Juice
Pomegranate Extract
PomWonderful
Questionnaire
Placebo

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009