Texas Urology Specialists Conducts Clinical Trial To Fight Prostate Cancer Recurrence

Investigational Drug Therapy for Localized Cancer

HOUSTON (Nov. 7, 2012) — Texas Urology Specialists, which is part of Texas Oncology, began conducting a Phase III clinical trial focused on improving localized primary prostate cancer treatment and preventing recurrence. The trial will study a new drug candidate, ProstAtak. The clinical trial drug – in conjunction with the standard treatment – has shown promising outcomes in previous Phase I and Phase II studies.

“This clinical trial is one of very few designed to target localized prostate cancer, before it has spread to other parts of the body, and prevent recurrence,” said Dr. Steven Sukin, a urologist with Texas Urology Specialists–Tomball and The Woodlands. “We are pleased to offer the opportunity to participate in this national clinical trial to our patients locally.

The ProstAtak treatment functions as a vaccine to fight prostate cancer recurrence. Based on gene transfer technology, ProstAtak is used in conjunction with standard radiation therapy to help the immune system detect and destroy remaining or recurring cancer cells.

“Radiation can be very effective, but having another tool to fight prostate cancer and the recurrence of prostate cancer could be a tremendous development for our patients,” said Dr. Howard Lewis, a radiation oncologist at Texas Oncology–Houston Willowbrook Radiation Oncology.

Almost 17,000 men will be diagnosed with prostate cancer in Texas this year. Thanks to regular cancer screening, the majority of prostate cancers are found in the early and intermediate stages – before symptoms appear and often before the cancer has spread. However, approximately 30 percent of patients can experience recurrence of their cancer even years after initial radiotherapy or surgery treatment.

Clinical trials like this one work to address scientific challenges and identify better ways to treat, diagnose, and prevent cancer-related diseases. ProstAtak has successfully completed the first two phases of clinical trials and is now in the last phase. In the phase II study, the rate of prostate cancer recurrence was reduced from an expected 30 percent down to 10 percent. The biotechnology company Advantagene, which was founded in Houston and is now headquartered in the Boston area, is developing ProstAtak.

“We are thrilled to have Dr. Sukin and Dr. Lewis form part of the elite group of prostate cancer doctors and institutions in the country that are conducting this study,” said Dr. Estuardo Aguilar-Cordova, CEO, Advantagene.

Phase III trials are the final step to evaluate the efficacy of a new drug. This study will compare standard of care radiation treatment to radiation plus ProstAtak. To ensure reliability of results, patients are randomly assigned to one of the two groups. Patient volunteers selected to participate will receive three courses of either a placebo or the ProstAtak injection – a procedure requiring only a few minutes. All patients will receive the standard of care radiation they would receive if they did not participate in the study, and be monitored periodically for short and long-term effects as well as general health status.

Eligibility for clinical trials may depend on several criteria, including age, sex, cancer type, stage of cancer, previous treatments, date of last treatment, lab results, current medications, history of other cancers, and physical activity level. Patients interested in participating should call Texas Urology Specialists at 281-351-5174.