Texas Oncology Participates in International Prostate Cancer Study Culminating in FDA Approval
Promising Clinical Trial Results Point to Treatment That Extends Survival
new drug used to treat prostate cancer that is resistant to medical or surgical
treatments that lower testosterone showed significantly increased survival for
patients, according to a large international study published in the May 26
print edition of the New England Journal
of Medicine. Thomas Hutson, D.O., Pharm.D.,with
Texas Oncology–Baylor Charles A.
Sammons Cancer Center in Dallas, is co-author of the study, which examined
abiraterone acetate (Zytiga), in the fight against this type of advanced-stage
Following the Phase III
results, the FDA approved Zytiga in April 2011 for commercially available use
with prednisone (a steroid) in patients diagnosed with metastatic
castration-resistant prostate cancer who had received prior chemotherapy.
Phase III clinical trial studied the new cancer treatment using abiraterone
acetate and prednisone. Abiraterone acetate helps disrupt the enzymes that
speed cancer tumor development. Side effects included fluid retention and
swelling, related to elevated levels of certain hormones.
of the trial showed that the new treatment increased survival by approximately
four months, compared to placebo (sugar pill) plus prednisone. The average
survival for patients treated with abiraterone acetate was 14.8 months, while
the average survival for patients taking the placebo and prednisone was 10.9
months. This is a significant advancement for advanced-stage prostate cancer
patients whose disease is resistant to other treatments including hormone
manipulation and chemotherapy.
“When the initial
clinical results were so positive, we knew immediately that this was a
significant advancement for late-stage prostate cancer patients,” said Dr.
Hutson. “We are excited to be at the forefront of such innovative research.”
In addition to the Texas Oncology–Baylor
Center location, the
study was conducted at 146 other sites across 13 countries. Dr. Hutson enrolled
some of his own prostate cancer patients for the randomized, double-blind
participates in clinical trials ranging from Phase I through Phase IV studies.
Through its direct involvement and commitment to research, Texas Oncology has
played a role in the development of 43 Food and Drug Administration (FDA)
approved cancer therapies.