In anticipation of our Monday night teleconference on Provenge (see below for registration procedures) I am very happy to report that Dendreon is now detailing plans to move Provenge to earlier stages in the disease’s progress.
At the American Society of Clinical Oncology (ASCO) meeting in Chicago which is winding down today, Dendreon unveiled plans for three earlier stage clinical trials, two targeting advanced prostate cancer. This is great news for many of us.
Provenge was approved last year by the FDA for use with men with castrate resistant disease, but many people have been clamoring for its use in earlier stages of advanced prostate cancer. Provenge uses a man’s own white blood cells to stimulate the body’s immune system to fight cancer. In the clinical trials leading up to its approval Provenge demonstrated a survival advantage of approximately 4.2 months over placebo.
According to Mark Frohlich, Dendreon’s chief medical officer, “We weren’t able to take it to the next step….. It is no surprise that we were resource constrained until we had positive data from the trial, and we’ve had large commercial launch activities going on.” Dendreon is no longer resource constrained as they recently received FDA approval for thirty additional work stations and on June 30th Dendreon is anticipating a positive word from the FDA that would allow them to put on-line their new plant in Atlanta, Georgia. In addition to these two plants in the near future they are scheduled to complete construction on a plant located in the west coast of the United States.
The new main planned trial is designed to look at earlier use of the drug, in men who are still hormone responsive. They are anticipating having a sample size of approximately 1,700 men in this trial.
“We hope that the earlier you bring in the treatment, the longer that survival read out may be,” said Thomas Powles, co-chief investigator in the study and oncologist at St. Bartholomew’s Hospital in London. “You want to give this therapy to patients when their immune repertoire is functioning at its best,” he said. Provenge isn’t available in Europe yet–Dendreon plans to submit for European approval later this year or early next year.
That trial is anticipated to begin by year-end, while men should begin enrolling in the wider trial in early 2012. The larger trial should take three to four years to fully enroll. Since the trial will measure overall survival its duration will ultimately depend on when patients die, however, the trial will include an interim analysis. Since we know that men with advanced prostate cancer often can still live for 5 to 10 years the trial will take a long time to be completed, hopefully the interim results will be so positively dramatic that the trial will be ended early.
In another planned trial Dendreon is planning on evaluating men with a rising PSA to see if they would benefit from Provenge before or after getting hormone therapy. This trial will measure the immune response in the two group, and the data will likely be used to help design a larger Phase III study.
A third trial is a long-planned mid-stage study of a drug that works similarly to Provenge but targets a protein, called HER2/NEU, on the surface of some cancer cells. The trial tests the drug in bladder cancer, in the 50% of patients whose disease has the protein marker. The collected data also will be used for planning a larger trial.
Bottom line, we will soon see the launching of vital new trials that will hopefully usher in the use of Provenge at earlier stages and with hopefully even larger survival benefits.
Joel T Nowak, M.A., M.S.W.
About Malecare’s Teleconference:
Malecare Cancer Support’s Advanced Prostate Cancer Program invites you to our teleconference on Provenge.
The free Teleconference will begin 6PM EDT, Monday, June 13, 2011. Please register at http://bit.ly/kKuByH Call in number and code will be emailed to you, along with info on how to ask your specific question of our guest.
Joel Nowak, MSW, Director of Malecare Advanced Disease and Advocacy will be speaking with Neal Shore, MD. Dr. Shore is affiliated with the Carolina Urologic Research Center, Linked Urology Research Network and Uropath and is a leading urologist in using Provenge on advanced prostate cancer.
Malecare Cancer Support is our country’s largest men’s cancer survivor support and advocacy national nonprofit organization. Malecare produces research, informational materials, and online and in-person support groups throughout the United States. Malecare also facilitates the only national support program for men presenting with advanced prostate cancer. This teleconference is part of that program.
Visit malecare.org for more information on prostate cancer.
Malecare Cancer Support services are free and open to all.
As I discussed earlier I have been my own trial being fortunate enough to get Provenge before my Gleason 9(4+5) with bone mets prostate cancer progessed on ADT and early treatment with taxotere/carboplatin.
I suspect and hope these meds will work better before your immune system is overwhelmed by turmor.
I have registered for this Teleconferance, but now find out that I will be actually in the air flying when it is on. I there any chance that you could recored it and offer it as a podcast to those who couldn’t call in?
Yes, The call will be posted on the Malecare web site (malecare.org). Once at the site click to the Advanced Prostate Cancer Program and you will be able to listen to the recording. It will take a few days for the recording to be posted.
i have recurrent prostate cancer that has manifested is self as four tumors on the rib, spinal colum and hip bone. I am interested in geting into a clinical trial to combat this. Initial treatment was cryoablation in march 4. 2002. I have a rising PSA, 6.78 AFTER 8 YEARS OF LESS THAN O.
You need to go on hormone therapy now. You should take 50 mg of Casodex and then ten days later have a Lupron (or trelstar or Zoladex) injection. Speak to your doctor today and make arrangements for this. A man with a rising PSA and mets should not be untreated. If you are still with your urologists move your care over to a medical oncologist once you have started the hormone therapy.
Once you have started the hormone therapy ask the oncologist about clinical trials. Go to http://www.clinicaltrials.gov and search for prostate cancer. Go through the current recruiting trials and see if any look interesting to you. Then print them out and bring them to the oncologist to discuss.
Hi Joel- Was researching, surfing the web. My father, 86 yrs. old in excellent health was diagnosed with prostate cancer in 2010. He has done hormone treatments, radiation, seeding and PSA levels really dropped to a good place. IN the last 6 months his PSA levels have gone up again to a crazy number. Recent CAT scan was negative but the PET scan came back with high suspicion of metastasized prostate cancer in the left perineum area. A specialized cancer blood test he took came back negative for cancer cells. His DR. is now suggesting Provenge treatments. He goes in tomorrow to see DR. to ask many questions. Given the recent research of Provenge clinical trials… is it really helping? He does not want to do Chemo. but wants to fight it however is best. He’s an active, working, engaged man who still jogs 4 miles/day. Your insight would be so appreciated. thanks.
The research is clear, yes Provenge can extend life with minimal side effects for most men. I would encourage him to get Provenge. There are now other treatments available that will also extend life, including Zytiga which has also been shown to extend life even when given prior to chemotherapy. I am also hopeful that by the end of this year or early next year MDV3100 will also be available. As far as his decision to not have chemotherapy, everyone has the right to make this type of decision, however this needs to e an informed decision. Some men do experience significant side effect issues from chemo, but others do not. Chemotherapy has been demonstrated to also extend life.- Joel
Thanks Joel for your time and information. He has decided to go through the Provenge treatments. Then there might be a possibility of more radiation. Hopefully the Provenge will be enough. He’s very well informed. He seems to be in good hands with his DRS. He’s a researcher and has been doing much reading. We can only hope that the near future brings more advanced treatments for prostate cancer and ALL other cancers. Thanks again. I hope you are doing well.
I hope that all goes well. I do urge you to remember that Provenge needs time to grab hold of the immune system and really work. Don’t rush to another treatment once he finishes the last tretament so that you don’t break down the immune system that Provenge is building up.
Thanks Joel. Have you done a round of Provenge yourself? My Dad started this week. Tuesday they recirculated his blood and took what they needed (Red Cross location in D.C.) and then they send to a lab in New Jersey and Friday he goes back to his Dr’s office to be infused with the blood that is treated with Provenge. It was a bit uncomfortable he says but he did ok. They put a shunt in his chest for easy access. I’m hoping he does ok after Friday with possible side effects. I’ve passed on your comments to him. He’s not up for chatting himself so I’m doing it for him. He’s been extremely private about his situation and only the immediate family knows what he is going through. It’s his choice and wishes not ours or my mom’s. We’re respecting his wishes. Any information you might pass on to me I will certainly pass on to him. Thanks again. – Joyce
One of the great things about Provenge is its minimal side effect profile. The wose I have heard about are flue like symptoms with a fever which only lasts for a day or two. Good luck to him and to you. He is lucky to have a great daughter. – Joel
Thought I’d give you an update on my Dad. He finished up his Provenge treatments about a month ago. Was not fun for him but we all had great hopes it would work. He’s been having back pain between his shoulders transmitting to his chest area. Today he went in for his 2nd PET Scan. Unfortunately it showed the cancer has metastasized to his upper back, chest and neck area. Which is why he has been feeling pain in those areas. Seems so fast from his last PET scan maybe 6 months ago before the Provenge treatments. Very sad day for us today. It seems the Provenge did nothing, the radiation which he did first after hormone shots did nothing, and the radioactive seed placement did nothing. We are so disappointed. His DR. told him today he should start chemo which my Dad has not wanted to do. Now it’s looking like he will be starting next week. I’m concerned about the treatments and how he’ll do. He has really aged in the last 6 months from a very vital 86 yr. old. I haven’t seen him in quite a while except via Skype. I’ll be flying home in a couple weeks to spend time with he and my Mom. My Mom is so sad but is a very positive person. They are fighting this together. They won’t settle for less. I don’t have a good feeling at all. My Dad was so disappointed with the news today. His PSA levels have shot way up. Doubled since the last test before the Provenge. Around 170! My Dad said he about fell off his chair when he heard that. Basically my Dad feels as we all do that really no one really knows much about prostate cancer and how to treat it. Now his body has been invaded by so many external toxins to add chemo on top of it all frightens me. Since I am a advocate of alternative remedies and doctoring, this is all very hard to stand back and observe. I hope you are doing well and look forward to any ideas you might have. Thanks so much. – Joyce
What I meant to say above is that my Dad got the results of the PET scan today. He actually had the scan done last Friday. ~Joyce
I am really sorry to hear the news about your dad. He is a lucky man to have your mom and you stand by with him. In the normal course of events chemo is the next treatment for your dad. Some men have been able to get Zytiga prior to chemo, you might ask your doctor about that. Additionally, there is a trial going on looking at Zytiga pre-chemtherapy. You can find out more about that trial at http://www.clinicaltrials.gov (then search for Zytiga). – Joel