A Patients Experience with Provenge clinical trial - SB

There are two patient written experiences with Provenge. Jack Beaven's has been on this website for a long time and SB recently documented his experience from 2004 as follows:

Recent First Person Report on Provenge -- from 2004, but written 2009 SB

My experience in the Provenge trial was interesting, frustrating and either I was in the placebo group or the treatment did not work for me. I was accepted into the study in January 2004 at the Lutheran General Hospital site in Chicago. My home is in Oklahoma, but Chicago was the closest site and one of my sons lives in Chicago. The process started with three months of Lupron to assure that I was not hormone refractory. When that injection of Lupron "expired" I had three treatments starting April 14, 2004. For these I reported to Lutheran General at 7:00 a. m. on a Monday morning for Leukapheresis. A 12 gauge needle was placed in each arm. My blood circulated through a centrifuge and white bloods cells were collected, and the rest of my blood was routed back into my system through the second needle. This process took about two hours during which time I had to keep my arms motionless because the metal needles were left in place, and any movement might cause them to break through the blood vessel wall. They could not use the customary plastic stents and withdraw the needles because the stents tend to clog.

The collected white cells were then sent to Seattle via air courier service where they were treated (or not.) The "treated" material was returned via air courier service on Wednesday afternoon (once as late as 7:00 p.m.) and administered into me via IV.  I would then have a week off and go back for treatment the next week. I had three treatments. My PSA became detectable five months after my last treatment, and by January 2005 my PSA was 2.7.

The study protocol provided one "booster" of what ever ones initial treatment was when the PSA reached 3. Study protocol did not call for another PSA test for three months, by which time my PSA was 21.36. I had one "booster" treatment 4/11/05 at which time my PSA was 25.71. A check on May 5, 2005 resulted in a PSA of 46.69. I continued to hope that the Provenge would kick in, but when my PSA hit 73.06 July 12, 2005, I went on 14-day regimen on Casodex and then resumed Zoladex.

My frustration is that I cannot find out in which arm of the study I was placed. This was a double blind study with 117 men receiving real treatment and 59 received a placebo. I have gone so far as to go to Dendreon headquarters in Seattle and "camp out" until I got an answer. I finally did speak to a person who said he was one of the doctors in charge of the study, but he refused to tell me in which arm of the study I had been placed. If anyone knows how I might find this information, please let me know.

Although I did not benefit from the trial, I do not regret having participated in it. I don't feel that I did any harm to myself, and perhaps down the road it may be of some benefit to others.

If no one volunteers for the trial studies, there can be no progress on finding a cure for this insidious disease.

Jack Beaven's experience begins on clintrialsJB1 and continues on clintrialsJB2.