Back to results

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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pomegranate extract

pomegranate juice

placebo

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, prostate-specific antigen, PSA, pomegranate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

UCLA School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT00732043

First Posted

August 7, 2008

Last Updated

March 15, 2012

Sponsor

Roll International Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00732043

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roll International Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, prostate-specific antigen, PSA, pomegranate

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

pomegranate extract

Intervention Description

8 oz per day, 48 months

Intervention Type

Dietary Supplement

Intervention Name(s)

pomegranate juice

Other Intervention Name(s)

PomWonderful

Intervention Description

8 oz per day, 48 months

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

8 oz per day, 48 months

Primary Outcome Measure Information:

Title

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

Time Frame

48 months

Secondary Outcome Measure Information:

Title

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

Time Frame

48 months

Title

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

Time Frame

48 months

Title

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

Time Frame

48 months

Title

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

Time Frame

48 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan J Pantuck, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arie S Belldegrun, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA School of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1738

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs