Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00731848 |
Recruitment Status
: Unknown
Verified March 2012 by Roll International Corporation.
Recruitment status was: Active, not recruiting
First Posted
: August 11, 2008
Last Update Posted
: March 16, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Dietary Supplement: pomegranate liquid extract | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Extension Study of the Effects of Pomegranate Extract on Rising Prostate-specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer. |
Study Start Date : | February 2008 |
Estimated Primary Completion Date : | January 2014 |
Estimated Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Intervention 1
|
Dietary Supplement: pomegranate liquid extract
Pomegranate liquid extract, 8 oz per day, for 52 weeks
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- The within-subject difference between the PSA doubling time from the end of double-blind placebo treatment to the end of open-label pomegranate extract treatment. [ Time Frame: 12 months ]
- The effect of treatments on response rates for positive PSA doubling times (greater than 150% baseline), and for negative post-treatment PSA doubling time (i.e., declining PSA), and for changes in absolute PSA values. [ Time Frame: 12 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:
- Documented disease progression while on placebo in the GUP-0205-1 or GUP-0205-1XX study (a ≥100% increase over baseline serum PSA with a minimum increase of 1.0 ng/mL.
- 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 not to change/stop during the course of the study.
- Performance status 0 or 1 on the ECOG scale at time of entry into this extension Study.
Exclusion Criteria:
- Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject 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 ≤150 ng/mL at study entry.
- Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
- 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.
- Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study or ET of the double-blind extension GUP-0205-1XX); at any PSA level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
- Serum PSA doubling time <13 weeks (assessed at termination of the double-blind study or ET of the double-blind extension GUP-0205-1XX)).
- Evidence of 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.
- Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2XULN).

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): NCT00731848
United States, California | |
UCLA School of Medicine | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Allan J Pantuck, MD | University of California, Los Angeles | |
Principal Investigator: | Arie S Belldegrun, MD | University of California, Los Angeles |
Responsible Party: | Roll International Corporation |
ClinicalTrials.gov Identifier: | NCT00731848 History of Changes |
Other Study ID Numbers: |
GUP-0205-1X |
First Posted: | August 11, 2008 Key Record Dates |
Last Update Posted: | March 16, 2012 |
Last Verified: | March 2012 |
Keywords provided by Roll International Corporation:
prostate cancer prostate-specific antigens PSA |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |