Know Cancer

or
forgot password

A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled 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

Thank you

Trial Information

A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer


The primary objectives are to compare the effects of daily consumption of pomegranate liquid
extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the
end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.
Secondary objectives are to determine the effect of the pomegranate treatment on the change
in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor
recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to
determine the effect of the pomegranate treatment on response rates for positive PSA
doubling times and for declining post-treatment PSA levels (negative doubling times).


Inclusion Criteria:



- No evidence of disease progression while on any of the three GUP-0205 study products
(disease progression defined as > 100% increase in serum PSA [with a minimum value 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) is acceptable
provided the dose has been stable during the course of the GUP-0205- 1 study.

Exclusion Criteria:

- Significant concomitant medical or psychiatric condition that, in the opinion of the
Principal Investigator, would put the subject at risk or compromise the protocol.

- 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; at any PSA
level, the subject will be excluded if determined by the Principal 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).

- 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:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.

Outcome Time Frame:

48 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-0205-1XX

NCT ID:

NCT00732043

Start Date:

December 2007

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate-specific antigen
  • PSA
  • pomegranate
  • Prostatic Neoplasms

Name

Location

UCLA School of MedicineLos Angeles, California  900121973