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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 MedicineLos Angeles, California  900121973