Med professor tests new drug to prolong lives of prostate cancer patients

Oliver Sartor, the Plitz Professor for Cancer Research in the departments of medicine and urology at the Tulane School of Medicine, is conducting clinical trials of cabazitaxel, a new drug shown to prolong life in men suffering from advanced prostate cancer who have already exhausted conventional treatments.

Information from the study indicates a 30 percent reduction in risk of death during one year of treatment.

“These results demonstrate an important benefit for advanced prostate cancer patients who have limited options,” Sartor said.

The study divided patients into two groups, one that received prednisone and cabazitaxel, and another that received prednisone and mitoxantrone, a conventional first- or second-line treatment for prostate cancer. Patients in the cabazitaxel group lived an average of 15.1 months longer, while those in the mitoxantone group lived an average of 12.7 months. These results were significant because no other drug has prolonged life in patients who were no longer responding to other treatments.

 “An exciting aspect of cabazitaxel is that when all other options are exhausted this new drug has been found to prolong lifespans in men with advanced prostate cancer,” said Benjamin Lee, professor of urology at the Tulane School of Medicine and a pioneer in robotic surgery for prostate and kidney cancer.

Sanofi-Aventis, one of the largest pharmaceutical companies in the world with $44 billion in revenue in 2009, is developing cabazitaxel.

The major international trial of this drug is called the “treatment of hormone-refractory metastatic prostate cancer previously treated with a taxotere-containing regimen.”  The TROPIC study was conducted at 132 sites in 26 countries with 755 participants.

Sartor is a past chair-elect and a current member of the executive committee of the Department of Defense Prostate Cancer Integration Panel, which oversees $80 million in prostate cancer research.

“Oliver Sartor has really been one of the leaders in the fight against prostate cancer,” Lee said.

Patients involved in the trial had previously failed all traditional treatments such as radiation therapy, chemotherapy and hormone therapy. Hormone therapy involves the administration of drugs that reduce the production of testosterone, which fuels prostate cancer growth.

Based on the results of the TROPIC study, the U.S. Food and Drug Administration granted cabazitaxel fast track designation, a process designed to expedite the review of drugs that have the potential to fill unmet medical needs concerning serious diseases, which allows patients to receive important new drugs earlier.

“The company is working hard to submit to the FDA and anticipates submitting by the end of summer. [The company] is hopeful that the FDA will give its ruling before the end of the year,” Sartor said. “This is one of the several potential advances in prostate cancer treatment being studied. I am quite hopeful that one of these drugs becomes FDA approved.”