Posted on the Prostate Problems Mailing list about two months ago was a notice from Dr. Richard Lam about a clinical trial in which his office, Prostate Oncology Specialists, will participate.
What I found particularly interesting in this trial is that it was evaluating a potential new drug, abiraterone acetate, which could be used after the failure of Taxotere. Currently, we have only one approved chemotherapy drug to treat advanced prostate cancer. Once we become Taxotere-refractory all that is available to us is palliative care.
I also thought that this trial was timely in light of yesterday’s post (June 3, 2008), “Maybe A Misnomer – Prostate Cancer Resistance to Androgen Deprivation Therapy.” In this prior post, I spoke of research that poses one of the theories as to how prostate cancer becomes androgen independent. The underlying theory is, that distant tumors at the cellular level, manufacture their own androgens that are able to feed the cancer. My take home message was that we need to develop new, supplementary treatment strategies that target the distant tumors at their cellular level.
Dr. Lam’s announcement about the clinical trial of abiraterone acetate seems to fit directly into this category. Clinical trials are our best shot at improving our lot and expanding our options. We are in desperate need of more and better treatments for prostate cancer. The following is Dr. Lam’s recruiting announcement. If you missed it on the board, here is an opportunity get involved to gain access to cutting edge treatments and contribute to the progress of our fight against prostate cancer.
“I would like to inform you of a new multicenter, multinational study that
Prostate Oncology Specialists will be participating in. This phase III
trial, COU-AA-301, involves a new agent named abiraterone; this novel
adrenal androgen inhibitor has exhibited excellent PSA response rates
(greater than 50%) in phase II studies involving androgen-independent
chemo-naïve and Taxotere-refractory patients. What makes abiraterone unique
is its added ability to deplete androgens intracellularly in malignant
cells.
As you are aware, two large studies have demonstrated that Taxotere improves
overall survival for men with hormone refractory prostate cancer. However,
once patients progress on Taxotere, there are no FDA-approved therapies.
The goal of COU-AA-301 (this trial) is to demonstrate a clinical benefit of abiraterone
for this clinical scenario.
Study Design
Randomization allocation ratio of 2:1 between abiraterone plus prednisone
and placebo plus prednisone.
Inclusion Criteria
1. Ongoing androgen deprivation with a testosterone level<50.
2. Evidence of radiographic or PSA progression.
3. Exposure to at least 1, not more than 2, chemotherapy regimens; 1
regimen must include Taxotere.
4. Serum creatinine less than 1.5x ULN.
5. Serum albumin>3.0.
6. Hemoglobin>9.0.
7. ECOG performance status of 2 or less.
8. Histologically confirmed adenocarcinoma without neuroendocrine or
small cell features.
Exclusion Criteria
1. Abnormal kidney or liver function.
2. Serious non-malignant disease, including uncontrolled congestive
heart failure, hypertension, infection, hepatitis, severe gastrointestinal
disorders, or adrenal dysfunction.
3. Prior ketoconazole exposure.
4. Radiation, chemotherapy, or surgery within 30 days of the first
dose.
If you have any questions, please call me anytime at 310-827-7707.
Sincerely,
Richard Lam, MD”
The abiraterone acetate trial is being sponsored by Cougar Biotechnology Inc. (NASDAQ CGRB).
Additional information about the trial can be seen at the National Cancer Institutes (NVI) clinical trials web page located at :
http://tinyurl.com/6j4pug
Joel T Nowak MA, MSW
I am interested in this trial on abiraterone acetate . Please advise how I could get on to it.
Go to: http://tinyurl.com/6j4pug and click on the link called study sites. This study as 36 separate locations. Find the sight that is close to your home. If this site is marked recruiting, contact the listed person at that site.
Joel
I am very interested in the abirateron acetate therapy for my advanced prostate condition. My PSA in April08 was 116. Previous measurements showed that the PSA increased from 56 in Jan 01 exponentially to 116 in the four month period.
Per the recomendation of my Urologist I took a shot of Lupron. At this date my PSA level is 2.1. I am scheduled for local radiation treatment, however, I learned from other sources (one of them the Prostate Cancer Research center) that radiation may not be the best choice for me due to micro-spreading.
It is my understanding that your trials require that we have tried Chemotherapy and failed before I am eligible for the abiraterone treatement. I don’t see why I need to subject my body’s to the effects of chemo if this abiraterone works the way you think it does.
In general, do a high percentage of prostate patients do well with Chemo? From what I seen, they do not. It just seems counterproductive to me that it is necessary to take Chemo where history shows that it does not have a good success rate, while there is a promise or at least a good chance that the success rate is better with the abiraterone.
Is there any chance that I could be put on a abiraterone regime without the need of poisening me with Chemo? Would it not be better to have a test subject who’s immune system hasn’t been destroyed Chemo?
I haven’t got much time left and I rather take my chances with Abiraterone than Chemo or Radiation.
Thanks,
Jim
Jim,
My PSA history at the recurrence is not much different than yours, but my PSA only made it to 86. It was made very clear to me that radiation was not an appropriate treatment because a PSA in these elevated levels indicated that the cancer was in fact no longer just in the prostate bed which is would be the target of the radiotherapy.
I too started on a hormone blockade and have achieved good results to date. I have elected to use an intermittent schedule, you can read about my experience under the about tab on the right margin of the blog.
I would urge that you immediately find a good medical oncologist who specializes in prostate cancer instead of continuing using your urologist for the management of your prostate cancer.
Clinical trials are very structured and do not allow any divergence from the approved protocol. It is most common that the trials use subjects that are more advanced in their disease. I agree, it does seem to fly in the face of simple logic. The Provenge clinical trial is a good example of this problem.
There are a number of things I do advise: 1- start seeing a medical oncologist with a prostate cancer specialty, 2- Reconsider adiation as a treatment and discuss it with your new oncologist, 3-With the oncologist search for a clinical trial that makes sence for you (go to http://www.clinicaltrial.gov) 4- join the advanced prostate internet group at: http://healthunlocked.com , 5- participate in a support group, read all you can about prostate cancer and 6- remember that there are mny of us with advanced prostate cancer who continue to live long and happy lives.
Joel
Joel,
Did Jim get an answer to his very logical question about “why chemotherapy failure before Abriaterone?”
I,at 77, have had PC since 2002. I’ve gone through Cryosurgery, radiation and almost constant hormone therapy. I am currently on Nizoral/Hydrocortizone with some success. PSA down from 75 to 21 in a month. The PC is no longer in the prostate because of either the cryo or the radiation but has spread to the lymph nodes and rib cage. No vital organs as of end of May. Most importantly, I feel good and going on with my life. We have vacation plans out until next May.
Am under the care of Dr. Petrylak at Columbia Presby.
I agree with your assessment of the advantages that PC has added but could live very well without it.
You comments would be welcome.
Stan Schwartz
Stan,
I did respond to Jim both as a comment on the blog and in a separate email. I am going to also send you an email.
The protocol for clinical trials are designed to be very specific and must be completely followed without any diversion. So, even if there seems to be a better population for a trial, if the protocol calls for a sicker population, they are the only participants that can be let into the trial.
The FDA strongly encourages using a population for clinical trials that have already received all available approved treatments. This is an ethical consideration You don’t want to deny anyone the best possible approved treatment available. If you use subjects who have not had all treatments those who are receiving a placebo in the trial are really being denied treatment which is available.
I too see Dr. Petrylak at Columbia. Since you are seeing a New York City doctor I assume that you are near the city. I would recommend a weekly support group sponsored by Malecare in which I participate. We meet on Wednesdays in Union Square between 6 p.m. and 7:30 p.m. If you might be interested let me know and I will tell you more about the group.
Hi,
I am a candidate for the Phase 3 trial in the UK and have started a blog on my experiences. If anyone is interested go to theboyceys.com
I am interested in the abiraterone trial, are you still recruiting?
Are there other sites..???
Thank you.
James,
Currently there are two different trials that are still recruiting and one additional one that will be recruiting subjects. Go to http://www.clinicaltrials.gov and searc for abiraterone to find out about these trials.
Joel
I’m in a similar situation as the other Jim. I was diagnosed in 2003 and have undergone brachytherapy and radiation initially. Since that time my psa has started climbing back up twice at which time I underwent hormonal therapy for approx. a year each time. Recently, I learned that the cancer has matastasized to my cervical area and therefore I will be starting a radiation treatment along with another round of hormonal therapy. You would think that they would also consider a trial of those whose pc has not spread as much as the current standard.
ps: I tried to access the website listed for the support group and learned it was no longer active.
Yet another Jim
My 86 year old husband is interested in the trial. Is it true that if he has had ketoconosol treatment (for 6 months) he is not eligible?
Exposure to (use of) any ketoconosol would eliminate your husband from participating in this trial. If he has bone mets he might qualify for a new, very promising trial. Go to todays post (February 4, 2009).
Hi! I am hormone resistant prostrate cancer patient and now residing in Scarborough,Canada. I have been taking hormone treatment since February,2001. Yesterday my Doctor told me that my toesterone is zero but my psa is 27 and rising. Can you kindly recommend me to a clinic that conducts Abiraterone Actate Trials.Kindly help me.Thank You,
Currently there are two different trials that are still recruiting and one additional one that will be recruiting subjects. Go to http://www.clinicaltrials.gov and searc for abiraterone to find out about these trials.
Joel
I have just learned of the Abiraterone Acetate trial and I believe that I am eligible for participation in it. However, I live in Central Florida (the Orlando-Tampa area) and have been unable to find a participating institution near me. Perhaps you have better information than I do in this respect.
Your assistance will be appreciated.
Thanks,
Ivan
Ivan,
Currently there are four separate trials being conducted in the United States. Only one of these trials is near you. It is coming out of the Boca Raton Community Hospital in Boca Raton. The contact at the hospital is Ms. Bonnie Pesacov at 561-416-8869.
The inclusion criteria are:
Inclusion Criteria:
* Metastatic castration-resistant prostate cancer
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status of either 0 or 1
* Medical or surgical castration with testosterone less than 50 ng/dL
* Able to provide written informed consent
I hope this helps and good luck
Joel
Hi, I am 3rd year med student following a patient with prostate cancer in the UK, he participated in this trial, and I am trying to research it further, although I am struggling with finding results to any of the trials already undertaken… can you help? Thanks Lexie
Lexie,
As far as I know there has not been any formal release of data from this trial. The informal information “floating around” is that the numbers have been positive. Although I doubt you will be able to get any actual data you could try and contact the medical director of the trial and make some requests.
Hi Joel, Thank you for your invaluable information in this forum. Hoping you might have an idea for my dad. 87 years old, about 18 months since his aggressive (Gleason 9) PC became hormone refractory/resistant. Tried for over a year to get him into various Abiraterone Trials here in Detroit and elsewhere without success.Have read everything there is to read, have even talked directly to some of the lead doctors at Cougar Biotech. Ultimately arrythmia excluded him from the trials, but not before the docs put him thru a gamut of expensive/painful tests and wasted precious time. The arrythmia was known before they started their pre Trial discovery, why they didn’t exclude him immediately you can only guess the reasons. Excuse me if I sound cynical. His bone scans now clearly show the metastes to the pelvis etc. He was working in our family business until last summer..but its clearly beginning to take its toll. Our docs at Karmanos seem to think we should just accept the inevitable, all they’re offering is chemo, but I’m pretty sure at this point we’d be adding insult to injury. He’s hanging in there but barely. I know we’re running out of time. Any creative thoughts you could offer?
Thanks, Mike
Mike,
You did not share your dad’s numbers and what treatments your dad has taken. I would need to know this information before sharing any thoughts.
I strongly recommend that you sign up to Malecare’s internet advanced prostate cancer group where you can consult with over 475 other people who are dealing with advanced prostate cancer. You can join by going to: http://health.groups.yahoo.com/group/advancedprostatecancer/join
Joel
We want to use Abiraterone as trial for my father who has advanced prostate cancer(Hormone refractory) with bone metastasis.Zoladex & radiotherapy has been used for him. But now PSA level is shooting up. his oncologist recommanded for chemotherapy. Please let us know how can we participate in Abiraterone trial. We are living in dhaka, Bangladesh.We have contacted a number of sites offering clinical trials but no one is agreed to allow us participate in the trial living in dhaka, Bangladesh.
There isn’t anything that you can do to get into a trial if the sites don’t accept your dad. You should ask your dad’s oncologist about using some of the 2nd line hormone blocks before going to chemo. Is he on zometa to make his bones less hospitable to further bone met development?
Joel
Dear Joel
I am asking for your kindly help for my father-in-law’s prostate cancer. He had a surgical operation to remove cancer 6 months ago, and his PSA stays at 0 that time. However, his PSA raises up to 6 in 6 months. He is taking rediation treatment now. Our ductor told us he does not have long-term transfer yet (not 100% sure), but we have to chance hormone to inhibit the progress. He told us that new medicine can only last for one year in this way if it works. There is no long-term solution in place.
My father-in-law is 65 years old. He is still very strong. He even can run 3000m easily. I cannot believe that this is the only way for him. We are in Taiwan. We watch the release of Abiraterone for long. We understand it is a long shot for us if we wait for its formal release, especially in Taiwan. To work out an urgent situation, I am looking for the chance to join the release trial to save my father.
Please kindly help to answer following questions if you can. It will help us for our next move :
1. Will Abiraterone have a trial in Taiwan or somewhere in Asia? When will it happen? Who should I conatact to?
2. Is it possible for us to join Abiraterone trial in US? Is there any formal procedure for foreigner? Who should I conatact to?
3. If we cannot join the trial in US, can we join the treatment of after Abiraterone formal release? When can we have it?
Please review our case, and give us your suggestions. Thanks for your kindly help.
best regards
Steven
There will soon be a “compassionate release” of Abiraterone Acetate following the deblinding of the Phase 3 trial (announced two weeks ago – around September 9, 2010). However, my oncologist claims that the minimum PSA will probably be the same as the Phase 3 trial – namely 5.0. However, I searched clinicaltrials.gov as well as contacted the company sponsoring the research trial and there is no mention of a minimum PSA. What is the real scoop on this?
We will have to wait and see. Johnson & Johnson claims they will be making announcments in October 2010 on the NCI web page. -Joel