Status:
UNKNOWN
Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer
Lead Sponsor:
Roll International Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 stra...
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 thera...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00731848
Start Date
February 1 2008
End Date
January 1 2015
Last Update
March 16 2012
Active Locations (1)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095