Effects of Pomegranate Juice or Extract on Rising PSA Levels in Men Following Primary Therapy for Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00413530
First received: December 15, 2006
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Primary Objective:

To compare the effects of daily consumption of pomegranate liquid extract, and 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.

Secondary Objectives:

  1. To determine the effect of the pomegranate treatments on the change in serum 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 serum PSA doubling times and for declining post-treatment serum PSA levels (negative doubling times)

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

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Serum PSA Doubling Time at End-of-treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Effects of Pomegranate Treatments on change in PSA doubling time from baseline to end-of-treatment [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate liquid extract
Subjects will orally receive 8 ounces of pomegranate liquid extract (equivalent to 1.6 mmol of total polyphenols per day) or matching placebo daily. Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
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.
Other Name: PomWonderful
Behavioral: Questionnaire
Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
Placebo Comparator: Matching placebo juice
Subjects will orally receive 8 ounces of placebo liquid daily. Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
Other: Placebo
Subjects will orally receive 8 ounces of placebo liquid 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 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 </= 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413530

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00413530     History of Changes
Other Study ID Numbers: 2006-0220
Study First Received: December 15, 2006
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014