A new drug can mean new hope for men dealing with advanced-stage prostate cancer.

First there was the approval and widespread use of Taxotere, which was the first chemotherapy drug that showed proven survival benefit for those for whom previously accepted treatment failed.

Now, Daniel Petrylak, M.D., who was one of the key investigators in the trials leading up to that approval, is involved in another potential major therapeutic breakthrough that could offer hope-and longer-term survival-for patients for whom primary chemotherapy treatment has failed.

A drug called Satraplatin, an oral compound, is being investigated for patients who have not been helped by a prior treatment of chemotherapy and have begun advancing while on androgen ablation therapy, a condition known as hormone-refractory prostate cancer. The clinical study, in which Dr. Petrylak has teamed with other leading cancer researchers-Drs. Oliver Sartor, Fred Witjes and Cora Sternberg-was designed in conjunction with the FDA to ensure positive research outcomes.

The trial was designed to measure disease "time to progression" (TTP) as its primary endpoint. Preliminary findings show a lower toxicity than other drugs typically used and, most importantly, showed excellent TTP in the main areas of concern: pain, skeletal events, resistance to drug effectiveness, and death. Overall, there was a 40 percent reduction in the rate of progression.

Satraplatin is a novel platinum compound that has shown anti-tumor activity in several cancers including advanced hormone-refractory prostate cancer.

Preliminary results of a phase III randomized trial comparing Satraplatin + prednisone (a steroid) to placebo + prednisone showed a 33 percent reduction in the risk of disease progression with increasing improvement noted over time.

At six months, 30 percent of the patients taking Satraplatin had no disease progression compared to 17 percent of the patients taking the placebo. At 12 months, 16 percent of the Satraplatin group had no disease progression compared to 7 percent of the placebo group.

The reported side effects were mild to moderate and included low white blood cell and platelet count, nausea, vomiting and diarrhea. The ideal candidate for the drug is that patient for whom primary chemotherapy has failed.

The manufacturer, GPC Biotech, Inc., is making Satraplatin available on a limited basis through an Expanded Access Program.

If you are interested in this program, your physician can get further information about enrollment at or (800) 349-8086.

New drugs are showing promise in the treatment of prostate cancer, says Dr. Daniel Petrylak.

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