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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 ³.

Principal Investigators

Dr. Allan Pantuck Principal Investigator

Dr. Allan Pantuck and Dr. 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 one 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 ⁴.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts ⁵ or call 1-800-4-CANCER (1-800-422-6237) for more information.

Glossary Terms

Any method that uses cold temperature to treat disease.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A subtropical shrub or tree. Juice from the fruit may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels. It is being studied for its ability to delay or prevent recurrent prostate cancer. The scientific name is Punica granatum.

A protein made by the prostate gland and found in the blood. Prostate-specific antigen blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland. Also called PSA.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiotherapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiation therapy.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.