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.
18 Years
N/A
Male
Prostate Cancer
Trial Information
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.
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.
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).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Allan J Pantuck, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Los Angeles
Authority:
United States: Institutional Review Board
Study ID:
GUP-0205-1X
NCT ID:
NCT00731848
Start Date:
February 2008
Completion Date:
January 2015
Related Keywords:
- Prostate Cancer
- prostate cancer
- prostate-specific antigens
- PSA
- Prostatic Neoplasms
Name | Location |
|---|---|
| UCLA School of Medicine | Los Angeles, California 900121973 |
