Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336934
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2006-06-13
Brief Title:
Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
Sponsor:
Roll International Corporation
Organization:
Roll International Corporation
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen PSA levels after surgery or radiation therapy for localized prostate cancer
PURPOSE This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer
PURPOSE This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen PSA levels after surgery or radiotherapy for localized prostate cancer
Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients
Secondary
Assess toxicities associated with daily oral dosing of pomegranate extract in these patients
Determine the effect of pomegranate extract on positive PSA doubling-time outcome defined as greater than 150 baseline or a negative post-treatment PSA doubling time ie declining PSA
OUTLINE This is a multicenter double-blind placebo-controlled randomized study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral pomegranate extract daily
Arm II Patients receive oral placebo daily Treatment in both arms continues for up to 1 year in the absence of disease progression
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Primary
Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen PSA levels after surgery or radiotherapy for localized prostate cancer
Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients
Secondary
Assess toxicities associated with daily oral dosing of pomegranate extract in these patients
Determine the effect of pomegranate extract on positive PSA doubling-time outcome defined as greater than 150 baseline or a negative post-treatment PSA doubling time ie declining PSA
OUTLINE This is a multicenter double-blind placebo-controlled randomized study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral pomegranate extract daily
Arm II Patients receive oral placebo daily Treatment in both arms continues for up to 1 year in the absence of disease progression
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0507059-01 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| P30CA016042 | NIH | None | None |
| ROLL-GUP-0205-1 | None | None | None |