Scott & White Hospital Starts Phase II Clinical Trial - Next Test For Agent That Targets Prostate Cancer Cells

Main Category: Prostate / Prostate Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 14 Apr 2008 - 3:00 PDT

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Scott & White has begun recruiting patients with recurring prostate cancer to participate in a clinical trial that uses a PSA (prostate specific antigen) activated chemical injected into the prostate that attaches to prostate cancer cells and causes cell death.

"This is an important and exciting step in this process," said Dr. Scott Coffield, the principal investigator, a urologist and professor of surgery at Scott & White. "We are trying to determine if this agent is effective in destroying cancer cells in the prostate using varying doses of the agent, which has demonstrated safety in an earlier trial."

To be eligible to participate in this study, a patient must have been diagnosed with prostate cancer that has recurred after completing treatment by external beam radiation therapy or radioactive seed implant.

Protox Therapeutics, Inc., a Canadian company, developed the drug and has received clearance from the U.S. Food and Drug Administration to proceed with a Phase IIa clinical trial. According to Protox officials, PRX302, as the agent is currently called, is injected into the prostate where it turns into a potent cell-killing toxin when it comes in contact with PSA-producing cells.

The purpose of this study is to determine therapeutic activity of different concentrations of PRX302 at increasing volumes as well as the safety and tolerance among study subjects after injection into the prostate. The study is expected to enroll 30 subjects.

Scott & White's Genitourinary Cancer Team/Scott & White Cancer Center in Temple is the primary study site for this trial. Participants will receive screening, laboratory testing, a procedure to administer the agent, and up to nine follow-up visits.

According to American Cancer Society data, prostate cancer strikes more than 230,000 men in the U.S. each year, resulting in approximately 30,000 deaths.

In a Phase IIa clinical trial, an investigational drug is tested in a small group of people to evaluate the drug's safety, determine what the range of safe dosage is, and to identify side effects. An investigational drug is one that is under study but does not have permission from the U.S. Food and Drug Administration or any regulatory authority to be legally marketed and sold. If approved by regulators, additional clinical trials may be conducted on larger groups for further evaluation and to gather more information, to help determine safe use of the drug, and if it will eventually be approved for general use.

In addition to the recurrent prostate cancer, other requirements must also be met to be considered for participation in this clinical trial. For more information on enrolling in this clinical trial, contact research coordinators Nancy Bowman or Richard Castillo at 866-226-3534, or visit the study's Web site http://protox.sw.org.

About Scott & White

Scott & White Healthcare is a three-hospital health care system established in 1897. Recognized among the nation's 100 Top Hospitals, Scott & White is the principal teaching facility affiliated with the Texas A&M Health Science Center College of Medicine. Along with its flagship hospital and clinic facility in Temple, Texas, Scott & White also includes its Continuing Care Hospital on Temple's West Campus and the 72-bed acute care hospital at the University Medical Campus in Round Rock. With more than 650 physicians and scientists, Scott & White has become one of the nation's largest multi-specialty group practice systems.

Scott & White Healthcare