Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Roll International Corporation.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Roll International Corporation
Information provided by (Responsible Party):
Roll International Corporation
ClinicalTrials.gov Identifier:
NCT00731848
First received: August 7, 2008
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
This study is an open-label extension to the double-blind GUP-0205-1 and double-blind extension GUP-0205-1XX studies. High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from treatment failure to hormonal ablation. Eligible male subjects were previously assigned to the placebo group in the double-blind core study or the double-blind extension study and were diagnosed with disease progression while on placebo treatment. Upon satisfying all entry criteria, the subjects will receive open-label pomegranate extract for up to 48 months in the absence of further disease progression or intolerable toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: pomegranate liquid extract |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Roll International Corporation:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Intervention 1
|
Dietary Supplement: pomegranate liquid extract
Pomegranate liquid extract, 8 oz per day, for 52 weeks
|
Detailed Description:
This study is an open-label extension to the double-blind GUP-0205-1 and double-blind extension GUP-0205-1XX studies. Eligible male subjects, i.e.,men who had rising PSA levels following primary therapy for localized prostate cancer, were previously assigned to the placebo group in the double-blind study or the double-blind extension and were diagnosed with disease progression while on placebo treatment. Upon satisfying all entry criteria, the subjects will receive open-label pomegranate extract for up to 48 months in the absence of further disease progression or intolerable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00731848
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731848
Locations
| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
Sponsors and Collaborators
Roll International Corporation
Investigators
| Principal Investigator: | Allan J Pantuck, MD | University of California, Los Angeles |
| Principal Investigator: | Arie S Belldegrun, MD | University of California, Los Angeles |
More Information
| Responsible Party: | Roll International Corporation |
| ClinicalTrials.gov Identifier: | NCT00731848 History of Changes |
| Other Study ID Numbers: | GUP-0205-1X |
| Study First Received: | August 7, 2008 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016