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Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pomegranate juice
placebo
Sponsored by
Roll International Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor Documented rising prostate-specific antigen (PSA) Absolute level of PSA > 0.2 ng/mL after surgery Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy) PSA must be ≥ 100% above best nadir achieved PSA doubling time > 3 months or ≤ 24 months Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months The interval between PSA time points must be > 2 weeks PSA ≤ 7.0 ng/mL Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible Gleason score ≤ 7 No histologically positive lymph nodes No evidence of metastatic disease by physical examination, CT scan, or bone scan PATIENT CHARACTERISTICS: Life expectancy ≥ 6 months ECOG performance status 0 or 1 No significant concomitant medical or psychiatric conditions that would limit study compliance No known allergies to pomegranate extract No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months Diabetic patients entering study who have not had hemoglobin A_1c level measured in the past 3 months must have levels measured at study initiation No clinically abnormal laboratory values > 2 times the upper limit of normal PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer No finasteride or dutasteride at any time point after primary therapy and during study therapy No other concurrent commercial pomegranate products No other concurrent systemic or local therapy for prostate cancer Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm I

    Arm II

    Arm Description

    Patients receive oral pomegranate extract daily.

    Patients receive oral placebo daily.

    Outcomes

    Primary Outcome Measures

    Objective response

    Secondary Outcome Measures

    Response duration
    Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times

    Full Information

    First Posted
    June 13, 2006
    Last Updated
    August 8, 2011
    Sponsor
    Roll International Corporation
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00336934
    Brief Title
    Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Roll International Corporation
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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 (i.e., 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    183 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    Patients receive oral pomegranate extract daily.
    Arm Title
    Arm II
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receive oral placebo daily.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    pomegranate juice
    Intervention Description
    Given orally daily.
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    Given orally daily.
    Primary Outcome Measure Information:
    Title
    Objective response
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Response duration
    Time Frame
    12 months
    Title
    Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times
    Time Frame
    12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor Documented rising prostate-specific antigen (PSA) Absolute level of PSA > 0.2 ng/mL after surgery Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy) PSA must be ≥ 100% above best nadir achieved PSA doubling time > 3 months or ≤ 24 months Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months The interval between PSA time points must be > 2 weeks PSA ≤ 7.0 ng/mL Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible Gleason score ≤ 7 No histologically positive lymph nodes No evidence of metastatic disease by physical examination, CT scan, or bone scan PATIENT CHARACTERISTICS: Life expectancy ≥ 6 months ECOG performance status 0 or 1 No significant concomitant medical or psychiatric conditions that would limit study compliance No known allergies to pomegranate extract No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months Diabetic patients entering study who have not had hemoglobin A_1c level measured in the past 3 months must have levels measured at study initiation No clinically abnormal laboratory values > 2 times the upper limit of normal PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer No finasteride or dutasteride at any time point after primary therapy and during study therapy No other concurrent commercial pomegranate products No other concurrent systemic or local therapy for prostate cancer Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allan Pantuck, MD
    Organizational Affiliation
    Jonsson Comprehensive Cancer Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Arie Belldegrun, MD, FACS
    Organizational Affiliation
    Jonsson Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer

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