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

Roll International Corporation

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: placebo

Dietary Supplement: pomegranate juice

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00336934

UCLA-0507059-01

ROLL-GUP-0205-1

CDR0000480402

P30CA016042 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

183 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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