NEW ORLEANS - A large international study has uncovered a new drug that appears to prolong the lives of men suffering from advanced stage prostate cancer and the new treatment could soon be on the market.
Part of the large international study, which was held at 146 sites in 26 countries, was done in New Orleans.
"This drug actually works,” said Dr. Oliver Sartor, the Director of Prostate Cancer Research at Tulane, who is one of the two principal investigators on the study. “It's the first drug ever to work in this phase."
The finding is history making. It is only the fourth time in medical history that a drug has been shown to help prostate patients live longer and it’s the very first time that a drug was tested and shown to prolong the lives of men who have advanced prostate cancer and who have failed all other treatment options.
"This particular trial takes the most difficult group," said Sartor. “These patients have failed hormones, they've failed chemotherapy. The options that they face are very limited but nevertheless, this trial worked and it was the very first trial in history to show effectiveness in this difficult to treat group of men."
Men in the study had prostate cancer that had spread past the prostate, to other sites in the body. As the trial progressed over 30 months, those men who lived the longest and got the test drug, doubled their life expectancy over the men who got the current treatment already on the market, a reduction in the death rate of 30 percent.
"The average patient on this trial were in their 60's and it's something, where I'd say, most of these patients are in their 60's or 70's. A few in their 50's," added Sartor.
There were 755 patients from around the world enrolled in the study. One patient was at Tulane.
Dr. Sartor will now travel to San Francisco to present his findings to 2,000 prostate cancer experts at the Genitourinary Cancers Symposium on Friday. The name of this new intravenous chemotherapy drug is Cabazitaxel.
Study data now go to the FDA on the fast track awaiting approval to be available to men.
The study is now closed.
It's hard for doctors to predict what will happen in the FDA approval process. But they hope it will be on the market by the end of this year.
