Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer - Full Text View

Sponsor:	Roll International Corporation
Information provided by:	Roll International Corporation
ClinicalTrials.gov Identifier:	NCT00731848

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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
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

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

No publications provided

Responsible Party:	MaryBeth Audickas, Radiant Research
ClinicalTrials.gov Identifier:	NCT00731848 History of Changes
Other Study ID Numbers:	GUP-0205-1X
Study First Received:	August 7, 2008
Last Updated:	August 8, 2011
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 February 09, 2012