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Abiraterone - Great News

mrspjd
Posts: 693
Joined: Apr 2010

Just returned from a PCa lecture by Dr Reiter, Urologist @ UCLA (So Cal). At the start of the lecture he announced that their Abiraterone (T4 stage trial drug) clinical trial has had such great success that the trial was stopped, study participants/data were unblinded, and apparently because of the great results, ALL the participants were given the drug! This is great news that will hopefully play an important role in getting the drug fast-tracked through the FDA as all the data comes in from the various institutions/centers conducting the trials. (I realize this may not be soon enough for some, however, it does provide hope for the future.)

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Kongo
Posts: 1167
Joined: Mar 2010

mrspjd:

Thanks for that update. It sounds like good news. I have read that Abiraterone lowers PSA and shrinks tumors for men who are castrate resistant and other forms of HT are no longer effective. Did the lecturer give any indication that this drug might be used in earlier stages of cancer or in conjunction with say IMRT or BT? Did he address what the common side effects were?

I know that UCLA has a great lecture series and you're fortunate to be close enough to attend.

mrspjd
Posts: 693
Joined: Apr 2010

Dr. Reiter's lecture mostly discussed the robotic surgery that he performs almost exclusively, along with using better imaging techniques to define the scope of the RRP for each individual case with the goal of perserving function and containing the PCa. He reviewed several of his case studies. Per his bio, along with the Dept of Urology, he works with the UCLA Specialized Program of Research Excellence (SPORE).

At the beginning of the lecture (& unfortunately not discussed in the lecture itself) Dr. Reiter made an announcement that a drug in their (UCLA) clincial trial had been so successful that their study was halted, unblinded, and all study participants were given the drug. Surprisingly, he didn't even mention or specify the name of the drug during that announcement. It wasn't until the end of the lecture, during Q & A, that an audience member asked the specific name of the drug, and he replied "Abiraterone." He did not elaborate, other than to say that he actually saw men, who prior to being on the drug, had been in severe pain and could hardly walk--get up and walk without pain after being on the drug. He did not give any other details such as stats, tumor/mets shrinkage, length of time on the drug, side effects, or how this drug might be used in earlier stages of cancer or in conjunction with other PCa tx modalities as it's probably just to early to know (perhaps that would be a good future lecture topic). Certainly there is a lot of room for further exploration in the use Abiraterone, as well as other new drugs in the pipeline of clinical trials.

BRONX52
Posts: 156
Joined: Apr 2010

Thanks for sharing. By the way, were side effects discussed during this lecture ?

tarhoosier
Posts: 182
Joined: Aug 2006

The study the doctor referred to was the Phase III trial for men who were post chemo. The trial has NOT ended. It continues and those on the drug continue with the drug until progression and those on the placebo will now have access to Abiraterone if they choose. All men will be monitored and data collected as before. The trial has been unblinded because an independent monitoring committee has seen that there is no way the drug will not meet the endpoints. Thus there is no reason to deny men on placebo their access to this drug. It is not a cure, though for those in the target group, post chemo with few options, it has shown amazing activity. Use earlier in the disease state will require access to the drug by the FDA, creative application by doctors and openness by the insurers. There is currently another phase III trial in just such a situation with men treated with Abi before chemo. These men have rising psa on treatment prior to trial entry. So this drug will likely change prostate cancer treatment significantly. It may be used instead of Lupron and equivalents since it is oral. Cost is a major issue here. Speculation by a trial doctor in England to one of his patients suggested a monthly cost of 3000$. I have no idea where he came up with this number.

mrspjd
Posts: 693
Joined: Apr 2010

I in no way meant to imply that the study had ended, only that it was unblinded, continuing as unblinded & data was still being collected. I used Dr. Reiter's words, so I guess the word "halted" needed the clarification you so well articulated. Thank you for the clarification & I apologize if there was any confusion from my post. You seem very knowlegeable about Abiraterone & the various trials. Since many of us have heard the promising potential of Abi, wondering if you might elaborate/share your thoughts re your statement "So this drug will likely change prostate cancer treatment significantly." Thanks.

tarhoosier
Posts: 182
Joined: Aug 2006

The drug Abiraterone acetate was developed at Royal Marsden Hospital, London, and that is the premier UK cancer center. The drug appears to limit testosterone production in areas that conventional LHRH drugs like Lupron and equivalents do not access. Adrenal production, intracellular production and androgens produced from progenitor compounds such as cholesterol become relevant at the castrate resistant stage of treatment. Abiraterone appears to work in the majority of men post chemo. One of the questions about it is whether it works as well as drugs currently available but used off label (counter to approved uses). Abiraterone is tested only against those drugs currently proven for prostate cancer. Some doctors use ketoconazole, Leukine, and estrogen, all drugs approved for other uses, and find success equal to abiraterone. Whether Abi can consolidate such success and extend it is still in question. It is ALWAYS helpful to have another arrow in the quiver.
I believe the true success in Abi will be in its use earlier in the disease state. Taking a pill a day, even a large one, is often preferable to going to the doctor monthly or quarterly for an injection. And if the drug is beneficial at the post chemo stage, it may be even more useful earlier in the disease. The more cells disabled early in the disease then the fewer cells remain to mutate years later to a resistant state. The side effects are simply more of the same that exist for conventional androgen depletion therapy.
There is currently a trial testing abi prior to surgery(!) for higher risk men to see if it can delay or prevent recurrence. This is what I mean about advancing the treatment to earlier stages. Conventional androgen therapy has been tried in such a way and been disappointing.

mrspjd
Posts: 693
Joined: Apr 2010

Thank you for an educational & informative post. Wondering if the study you refer to for testing Abi prior to RP surgery is the same one discussed on bobper's August thread--"Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer?" http://www.clinicaltrials.gov/ct2/show/NCT00924469

I was surprised that trial includes RP as part of the protocol, but guess its not so shocking if you consider how critical the post RP path results will be in the collection of data for that study. If this is not the study you refer to in your post and you have other info, would really like to know more about it. Thanks again.
Best,
mrs pjd

stevefob
Posts: 1
Joined: Sep 2010

I'm new to this forum, diagnosed w mPC. Did the doctor say anything about the trial tat's been in the news the past couple of days, where all patients in the trial are getting abiraterone? How long of a difference in survival it had vs the other therapy?

mrspjd
Posts: 693
Joined: Apr 2010

First, welcome to the discussion board. I'm sorry to read of your mPCa diagnosis. This must be a difficult time. Hopefully you will find some info here that might be helpful, either from others to you, or from you to others, if you choose to share your experience.

Q & A is a good way to start. It's helpful to know your stats, if you are comfortable in sharing them, as that might elicit more replies. I have not heard or read anything in the news recently about Abi (as you indicated), and my initial comments were anecdotal based on a recent lecture (on a different but related PCa subject) I attended at UCLA. You pose some interesting questions that I would also like to see answered. Again, welcome.
Best,
mrs pjd

tarhoosier
Posts: 182
Joined: Aug 2006

I believe the trial you refer to is the abiraterone Phase III post chemo trial. The results are scheduled to be discussed at a European oncology conference in Milan 8-12 October. Until then no statistics are available. There are two concurrent trials with abi, one pre-chemo for men with rising psa and the other is the neo-adjuvant (at the same time) surgery trial mentioned in two posts above. That the cost and time necessary to conduct these trials is provided by the company and the participating oncology institutions suggest that this can be a valuable treatment at several disease stages. This is a Johnson & Johnson drug and more information may be available at their website. All will be revealed in the fullness of time

mrspjd
Posts: 693
Joined: Apr 2010

It appears that Abi is being tested in conjunction with Lupron, etc. in the trial previously posted. Has it been trialed independently and it's potential effectiveness been studied alone in previous trials or the Phase III trial (post chemo?) without what appears to be the "boost" from the ADT effect of Lupron?

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bobper8427
Posts: 14
Joined: Aug 2010

I was on Abby in the Phase III trial at DFCI - pre other treatment. PSA dropped in the first month from 3.9 to 0.64. The week before surgery it was 0.01. After RP, pathology report showed no cancer in lymphs and 0.0% residual cancer in prostate. Not bad. I had no side effects just the expected stuff from super hormone treatment.

tarhoosier
Posts: 182
Joined: Aug 2006

It is not quite correct to consider lupron a boost to abiraterone, in the face of a rising psa under treatment. When Lupron (or any similar drug) "fails" what is meant is that another group of cells has arisen which is resistant to the treatment. This tumor mutation must be addressed with other treatments. Lupron still suppresses the growth of those cells which are susceptible to it. In the face of a rising psa under treatment on Lupron (or equivalent) and the addition of abi shows metastases stable or shrinking it is assured that the result is from the addition of abi and not any new quality that lupron has brought to the mix.

mrspjd
Posts: 693
Joined: Apr 2010

Tarhoosier,
In the study http://www.clinicaltrials.gov/ct2/show/NCT00924469, unless I've possibly missed something, it does not apprear that one of the entry criteria is hormone refractory disease. Is that correct? If not correct then I understand your post, but if it is correct, and a study participant is enrolled without prior HT, or HT refractory & rising psa, how are they (docs) able to determine the effects/success of each drug independently (abi & lupron) as opposed to the combined effect? And what controls the lupron flare if no casodex is used--abi or ?? Sounds confusing, but hope the question makes sense...and sorry if I don't quite get the medical jargon correct...I'm not a doctor, but it sounds like you might be. Thanks

tarhoosier
Posts: 182
Joined: Aug 2006

The trial you note above is the one bobper is on. It is for men diagnosed with PCa and no other treatment beforehand. I was responding to your original post about the trial currently unblinded, the phase III post chemo trial.
In the case of bobper and men on the trial you note just above, the results of THAT trial are serum and molecular responses. The pattern of recurrence is known in high risk diagnoses and in that trial the hope appears to be to determine if doses of abiraterone before surgery will weaken and shrink the tumor sufficiently to have a result in blood and microscopy pathology that can be determined up to six months post surgery. These men are patients who would normally be eligible for surgery in any case, so this is just adding a "blast" of hormone reducing drug to see what happens. It is, as I noted in my original post, another attempt to move the drug to an earlier disease stage. If considered successful in phase II currently, it could easily move to stage III as the "placebo" would be conventional surgery versus abi+surgery.

mrspjd
Posts: 693
Joined: Apr 2010

tar,
Appreciate your answer. I hope that you might consider keeping us posted with updates on the Abi trials & info, etc. as your time permits.
mrs pjd

bobper8427's picture
bobper8427
Posts: 14
Joined: Aug 2010

Abiraterone has now been approved - drug name is Zytiga.....check out www.zytiga.com

SeattleJ
Posts: 32
Joined: Mar 2011

The phase II trial involving Abiraterone, Luprone and predinisone as a pre-adjuvant therapy prior to surgery is still continuing. I was on that trial and posted my results on bobper's thread.

This is great news that it was approved for metastic cancer!

John

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