Name of the Trial
Phase III Randomized Study of Pomegranate Juice in Patients with Rising Prostate-Specific Antigen Levels after Surgery or Radiotherapy for Localized Prostate Cancer (UCLA-0507059-01). See the protocol summary at http://cancer.gov/clinicaltrials/UCLA-0507059-01.

Principal Investigators
Drs. Allan Pantuck and Arie Belldegrun, Jonsson Comprehensive Cancer Center at UCLA

Why This Trial Is Important
Surgery and radiotherapy are common treatments for localized prostate cancer (cancer confined to the prostate gland). Following such treatments, doctors may monitor the blood level of a protein called prostate-specific antigen (PSA). An increase in PSA level may be an early indicator that prostate cancer has returned. Research has shown that the length of time it takes for a rising PSA level to double (called PSA doubling time) can be useful in predicting the risk of prostate cancer progression and death.

Currently, there is no standard treatment for men who have recurrent prostate cancer detected by an increase in PSA level only. Consequently, doctors want to develop treatments that can slow down or reverse increases in PSA without causing serious side effects.

In this trial, researchers are exploring the potential of pomegranate juice to slow or reverse increasing PSA levels in men who have undergone treatment for localized prostate cancer. Pomegranate juice is rich in phytochemicals, substances that have been shown in laboratory studies to inhibit cancer growth and spread. Men in this trial will be randomly assigned to drink a special preparation of pomegranate juice or a placebo drink daily for up to 1 year.

"In a phase II trial we conducted, daily consumption of pomegranate juice resulted in a significant lengthening of PSA doubling time and disease stabilization," said Dr. Pantuck. "We hope to verify those results in a phase III, double-blinded, placebo-controlled study."

Who Can Join This Trial
Researchers seek to enroll 250 patients aged 18 and over with prostate cancer that have completed prior surgery, cryotherapy, or radiotherapy but have rising PSA levels. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/UCLA-0507059-01.

Study Site and Contact Information
Study sites in the U.S. are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/UCLA-0507059-01 or call 1-800-4-CANCER (1-800-422-6237) for more information.