Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00732043
• Other study ID #: GUP-0205-1XX
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 7, 2008
• Last updated: March 15, 2012
• Start date: December 2007
• Est. completion date: January 2015

Study information

• Verified date: March 2012
• Source: Roll International Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, 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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• pomegranate extract
8 oz per day, 48 months
• pomegranate juice
8 oz per day, 48 months
• placebo
8 oz per day, 48 months

Locations

Country	Name	City	State
United States	UCLA School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Roll International Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.		48 months	No
Secondary	The mean change in PSA doubling time from baseline to end-of-treatment.		48 months	No
Secondary	Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.		48 months	No
Secondary	Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.		48 months	No
Secondary	Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).		48 months	Yes