Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00060086 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 7, 2003
Last Update Posted
: October 13, 2017
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RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels and may be effective in delaying or preventing recurrent prostate cancer.
PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Dietary Supplement: pomegranate juice | Not Applicable |
OBJECTIVES:
- Determine whether pomegranate juice can decrease or slow rising prostate-specific antigen (PSA) levels in patients who have undergone radical prostatectomy or radiotherapy for adenocarcinoma of the prostate.
OUTLINE: Patients receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 29-40 patients will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate |
Actual Study Start Date : | March 2003 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Pomegranate Juice
Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
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Dietary Supplement: pomegranate juice
Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
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- Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months [ Time Frame: Evaluated every 3 months for 18 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Must have undergone prior surgery or radiotherapy for the primary tumor
- Documented rising prostate-specific antigen (PSA) level, defined by the following criteria:
- Absolute level of PSA at least 0.2 ng/mL but less than 5.0 ng/mL
- Rising PSA level must be confirmed at least 1 week later
- Adequate PSA time points to calculate a PSA doubling time
- Gleason score no greater than 7
- Age 18 and over
- Performance status ECOG 0-1
- Life expectancy at least 6 months
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No other serious concurrent systemic medical disorders that would preclude study compliance
- No known allergy to pomegranate juice
- More than 4 weeks since prior participation in another experimental study
Exclusion Criteria:
- nodal involvement
- evidence of metastatic disease
- prior hormonal therapy
- concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer
- concurrent participation in another experimental study
- other concurrent systemic or local therapy for prostate cancer
- initiation or discontinuation of any new nutritional or dietary supplements during study participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060086
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1738 |
Study Chair: | Allan Pantuck, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00060086 History of Changes |
Other Study ID Numbers: |
CDR0000299439 P30CA016042 ( U.S. NIH Grant/Contract ) UCLA-0210049 11-001265 ( Other Identifier: UCLA IRB ) |
First Posted: | May 7, 2003 Key Record Dates |
Last Update Posted: | October 13, 2017 |
Last Verified: | October 2017 |
Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate recurrent prostate cancer |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |