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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336934
• Other study ID #: CDR0000480402
• Secondary ID: P30CA016042ROLL-
• Status: Completed
• Phase: N/A
• First received: June 13, 2006
• Last updated: August 8, 2011
• Start date: November 2005
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Roll International Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• pomegranate juice
Given orally daily.

Other:
• placebo
Given orally daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Roll International Corporation	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response		12 months	No
Secondary	Response duration		12 months	No
Secondary	Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times		12 months	No