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

NCT00732043 | Unknown Phase 2 DMC

• 1 other identifier: GUP-0205-1XX
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate-specific antigen; PSA; pomegranate

Outcome Measures

Primary Outcomes (1)

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

  48 months

Secondary Outcomes (4)

• The mean change in PSA doubling time from baseline to end-of-treatment.

  48 months

• Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.

  48 months

• Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.

  48 months

• Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).

  48 months

Study Arms (3)

1

EXPERIMENTAL

Dietary Supplement: pomegranate extract

2

EXPERIMENTAL

Dietary Supplement: pomegranate juice

3

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

pomegranate extract DIETARY_SUPPLEMENT

8 oz per day, 48 months

1

pomegranate juice DIETARY_SUPPLEMENT

8 oz per day, 48 months

Also known as: PomWonderful

2

placebo DIETARY_SUPPLEMENT

8 oz per day, 48 months

3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Roll International Corporation: lead

Study Sites (1)

UCLA School of Medicine

Los Angeles, California, 90095-1738, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Allan J Pantuck, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Arie S Belldegrun, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: December 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (1)