Clinical trial NCT00336934: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Roll International Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-15
Enrollment: 183
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response
timeFrame: 12 months
Secondary outcomes:
measure: Response duration
timeFrame: 12 months
measure: Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Allan Pantuck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jonsson Comprehensive Cancer Center
name: Arie Belldegrun, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: