PHILADELAPHIA, PA (June 26, 2012)—Surgery and radiation therapy are the two most common forms of treatment for newly diagnosed, non-metastatic prostate cancer. Now, an entirely new treatment for prostate cancer is under investigation at Fox Chase Cancer Center—a vaccine therapy called ProstAtak™.
Researchers at Fox Chase are investigating ProstAtak in combination with radiotherapy as part of a Phase III clinical trial. The treatment is a novel vaccine therapy that works together with radiotherapy to kill tumor cells in the prostate. It also stimulates a tumor-specific vaccine within the patient to kill cancer cells elsewhere in the body.
“This is a very exciting new direction for the treatment of prostate cancer that exploits the body’s own ability to kill cancer cells,” explains Mark K. Buyyounouski, MD, MS, director of clinical research and associate professor of radiation oncology at Fox Chase. “Our bodies have an amazing ability to heal many illnesses that occur throughout our lifetime and we are hopeful that this new treatment will help the body heal prostate cancer.”
Earlier clinical trials have shown ProstAtak to be safe and effective in killing prostate cancer. In a controlled, 71-patient, Phase II clinical trial, the treatment resulted in a greater than 3-fold decrease in tumor recurrence—going from greater than 30% to less than 10%—after a median follow-up of 6 years.
ProstAtak is administered by an injection into the prostate, very much like a prostate biopsy—but not nearly as traumatic because the needle size is smaller and no tissue is being removed. It then infects the prostate cancer cells and together with a drug called valacyclovir, which helps activate ProstAtak, triggers the body to seek and destroy cancer cells in the body.
Patients who volunteer to participate in the study will be randomly assigned to receive either ProstAtak or a placebo. “But, the odds are in favor of receiving ProstAtak since patients will have a two out of three chance of receiving the new treatment,” explains Buyyounouski.
“We are hopeful that this new treatment will result in fewer men having the cancer come back,” says Buyyounouski. Once patients have completed treatment, we will be monitoring them closely for any evidence of recurrence by measuring PSA levels, performing physical exams, and biopsying the prostate after two years. While the initial results with ProstAtak are encouraging, comparing this new treatment to current treatment standards is critical to ensure the new treatment really is worthwhile.
Men with clinically localized, non-metastatic prostate cancer, who are intermediate or high-risk for recurrence, may be eligible for this trial. Typically, these are patients with Gleason score 7 or more and PSA greater than 10 ng/mL. Participants receive the same radiation therapy as those not involved with the study. Hormonal therapy, which is also sometimes recommended with radiotherapy, is permitted but optional on this study. Prostate cancer patients previously treated with surgery or radiation therapy are not eligible for this study.
For more information about the study and how to participate, please call 888-369-2427.
The study is sponsored by Advantagene, Inc.
Background on Advantagene, Inc.
Advantagene, Inc. is a privately held biopharmaceutical company focused on oncology and immunotherapy based in Auburndale, Massachusetts, just outside of Boston. Since its founding in 1999, the company has advanced its lead clinical programs through Phase 2 and is entering Phase 3. The company is funded by private investors and grants from National Institutes of Health.