Bad for Prostate Cancer
According to a media release from Janssen Research & Development (a unit of Johnson & Johnson), an independent trial monitoring committee has advised the company to stop the randomized, Phase III clinical trial of abiraterone acetate + predisone compared to a placebo + prednisone in treatment of chemotherapy-naïve patients with metastatic, castration-resistant prostate cancer (mCRPC).
The phase III clinical studies on abiraterone (Zytiga) both in chemotherapy-treated and chemotherapy-untreated patients have been stopped early due to positive results, so that the patients in the placebo arm may also receive benefits of the drug.The first Phase III study was halted after a clear, median 4-month extended survival point had been reached. So all that be can said from this study is that it gave a median 4-month survival benefit, but this does not tell the real story of longer-term survivors on this drug.For long-term survival we need to look at the survivors from the initial trials. There is at least one 8-year survivor from the original Phase I trial and there are several 4-year survivors from the Phase II trials. There are also many 2-year survivors from the first enrollment of patients into the ongoing phase III studies. Although it is too early to tell the long-term benefits, these are positive signs. These are significant because the trials were carried out in the most difficult of prostate cancer cases, on the most resistant forms of prostate cancer that had failed all other therapies, including docetaxel chemotherapy. The typical average life expectancy of this cohort is about 14 months, so any life extension above that is good
Comments
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Moral Values in Clinical trials
Ralph
Thanks for posting the news. This is not the first time that scientists stop trial on ethic basis. The Alpharadin phase III trials were also stopped because of moral values. The guys on placebo start taking the drug also once it was found that the other group was benefiting by taking the drug.
What surprises me is that many already knew that Zytiga (abiraterone acetate) did work very well in guys taking it “off-label”. In any case, FDA would not pass the “bill” of approval with no trial.
Even though, Zytiga is not for everybody. It causes side effects being toxic to liver health. The drug must be given with control and constant vigilance. Test the lipids timely as you go along.
The best to you.
VGama0 -
Is Abi better now than later?
All:
This trial raises many questions, as is often the case. The trial had two main endpoints: Overall survival and Progression Free Survival (PFS). Progression was not defined in the online trial information but almost certainly included bone scans. It would be assumed that progression would be identified far ahead of mortality. This was the case in this trial. The Independent Monitoring Committee supervising the trial identified unmistakable evidence that progression was delayed in the Abi patients and thus a Primary Endpoint had been reached. Ethics require that the placebo patients receive the active drug and the Abi patients be aware of the arm they participated. The survival question was not answered. The company said there was a "strong trend", but fell short of proof. Since all patients are now on the active drug we will never know the answer about survival. It may not matter since evidence in patients treated off trial will accumulate in the coming years and, though anecdotal, will determine practice. It is my opinion that in order to hasten the application of the drug, considering competition with current and soon to be approved therapies, Johnson and Johnson designed this trial to give the drug the best chance at early success, regardless of the overall survival endpoint, which is unequivocal. It remains to be seen if the FDA will consider the PFS sufficient evidence to approve for earlier application.0 -
Is Abi better now than later?
All:
This trial raises many questions, as is often the case. The trial had two main endpoints: Overall survival and Progression Free Survival (PFS). Progression was not defined in the online trial information but almost certainly included bone scans. It would be assumed that progression would be identified far ahead of mortality. This was the case in this trial. The Independent Monitoring Committee supervising the trial identified unmistakable evidence that progression was delayed in the Abi patients and thus a Primary Endpoint had been reached. Ethics require that the placebo patients receive the active drug and the Abi patients be aware of the arm they participated. The survival question was not answered. The company said there was a "strong trend", but fell short of proof. Since all patients are now on the active drug we will never know the answer about survival. It may not matter since evidence in patients treated off trial will accumulate in the coming years and, though anecdotal, will determine practice. It is my opinion that in order to hasten the application of the drug, considering competition with current and soon to be approved therapies, Johnson and Johnson designed this trial to give the drug the best chance at early success, regardless of the overall survival endpoint, which is unequivocal. It remains to be seen if the FDA will consider the PFS sufficient evidence to approve for earlier application.0 -
Being ToxicVascodaGama said:Moral Values in Clinical trials
Ralph
Thanks for posting the news. This is not the first time that scientists stop trial on ethic basis. The Alpharadin phase III trials were also stopped because of moral values. The guys on placebo start taking the drug also once it was found that the other group was benefiting by taking the drug.
What surprises me is that many already knew that Zytiga (abiraterone acetate) did work very well in guys taking it “off-label”. In any case, FDA would not pass the “bill” of approval with no trial.
Even though, Zytiga is not for everybody. It causes side effects being toxic to liver health. The drug must be given with control and constant vigilance. Test the lipids timely as you go along.
The best to you.
VGama
VGama,
There is no doubt, you are correct! Zytiga is not for everybody, and yes you need to check your blood for liver problem's once a month. In taking this medicine, if don't live a healthy life by eating right and exercise. All the out side condition's and along with the medicine can be the down fall to your liver. All drugs have their side of effect. MD Anderson say the study was good, It was the choice for me to use, in other cases they might recomment Alpharadin, it look's very good! :-)0 -
Your experiences are very important to metarhoosier said:Is Abi better now than later?
All:
This trial raises many questions, as is often the case. The trial had two main endpoints: Overall survival and Progression Free Survival (PFS). Progression was not defined in the online trial information but almost certainly included bone scans. It would be assumed that progression would be identified far ahead of mortality. This was the case in this trial. The Independent Monitoring Committee supervising the trial identified unmistakable evidence that progression was delayed in the Abi patients and thus a Primary Endpoint had been reached. Ethics require that the placebo patients receive the active drug and the Abi patients be aware of the arm they participated. The survival question was not answered. The company said there was a "strong trend", but fell short of proof. Since all patients are now on the active drug we will never know the answer about survival. It may not matter since evidence in patients treated off trial will accumulate in the coming years and, though anecdotal, will determine practice. It is my opinion that in order to hasten the application of the drug, considering competition with current and soon to be approved therapies, Johnson and Johnson designed this trial to give the drug the best chance at early success, regardless of the overall survival endpoint, which is unequivocal. It remains to be seen if the FDA will consider the PFS sufficient evidence to approve for earlier application.
Ralph
Thanks again for sharing your info and stats. I read your comments on the other thread regarding symptoms and liver /kidney tests. Can you explain on the changes in life style recommended by your doctor?
What is the daily dosage (mg) you are taking?
I know that the drug is taken on an empty stomach. Do you have it in morning with the prednisone?
Can you exercise physically just after taking the drug?
Your experiences are very important to me and the many guys reading our posts.
It seems that you are in good hands. Your doctor is surely very advanced in this modern protocol and not many have that luxury in care attention. I hope Zytiga holds your case for many years. You may consider at one point to change to a newer CYP17 inhibitor (17α-hydroxylase/C17,20-lyase) named Orteronel (TAK700) or to TOK001. These seams to cover “fields” not done by Zytiga.
http://biotechstrategyblog.com/tag/abiraterone-acetate/
Another drug that you may benefit from adding to Zytiga cocktail is the MDV3100 which may be a substitute to the traditional Casodex (antiandrogen). This drug blocks the AR receptor (mouth of the cancer cell) in a very efficient way prohibiting what it is called intratumoral AR activity. Surely, more drugs mean more toxicity and the need of closer vigilance. I do not even know if these drugs do interact between them.
The nice thing with hormonal treatment is that newer drugs (second generation) are coming off the drawing board to give us a chance for continuing manipulation. When one fails another may take its place. Let's try to be fit.
Wishing you a continuous success.
Vgama0 -
lost my commentsVascodaGama said:Your experiences are very important to me
Ralph
Thanks again for sharing your info and stats. I read your comments on the other thread regarding symptoms and liver /kidney tests. Can you explain on the changes in life style recommended by your doctor?
What is the daily dosage (mg) you are taking?
I know that the drug is taken on an empty stomach. Do you have it in morning with the prednisone?
Can you exercise physically just after taking the drug?
Your experiences are very important to me and the many guys reading our posts.
It seems that you are in good hands. Your doctor is surely very advanced in this modern protocol and not many have that luxury in care attention. I hope Zytiga holds your case for many years. You may consider at one point to change to a newer CYP17 inhibitor (17α-hydroxylase/C17,20-lyase) named Orteronel (TAK700) or to TOK001. These seams to cover “fields” not done by Zytiga.
http://biotechstrategyblog.com/tag/abiraterone-acetate/
Another drug that you may benefit from adding to Zytiga cocktail is the MDV3100 which may be a substitute to the traditional Casodex (antiandrogen). This drug blocks the AR receptor (mouth of the cancer cell) in a very efficient way prohibiting what it is called intratumoral AR activity. Surely, more drugs mean more toxicity and the need of closer vigilance. I do not even know if these drugs do interact between them.
The nice thing with hormonal treatment is that newer drugs (second generation) are coming off the drawing board to give us a chance for continuing manipulation. When one fails another may take its place. Let's try to be fit.
Wishing you a continuous success.
Vgama
I type a reponse, and disappear????
Let me try it again0 -
ChangesVascodaGama said:Your experiences are very important to me
Ralph
Thanks again for sharing your info and stats. I read your comments on the other thread regarding symptoms and liver /kidney tests. Can you explain on the changes in life style recommended by your doctor?
What is the daily dosage (mg) you are taking?
I know that the drug is taken on an empty stomach. Do you have it in morning with the prednisone?
Can you exercise physically just after taking the drug?
Your experiences are very important to me and the many guys reading our posts.
It seems that you are in good hands. Your doctor is surely very advanced in this modern protocol and not many have that luxury in care attention. I hope Zytiga holds your case for many years. You may consider at one point to change to a newer CYP17 inhibitor (17α-hydroxylase/C17,20-lyase) named Orteronel (TAK700) or to TOK001. These seams to cover “fields” not done by Zytiga.
http://biotechstrategyblog.com/tag/abiraterone-acetate/
Another drug that you may benefit from adding to Zytiga cocktail is the MDV3100 which may be a substitute to the traditional Casodex (antiandrogen). This drug blocks the AR receptor (mouth of the cancer cell) in a very efficient way prohibiting what it is called intratumoral AR activity. Surely, more drugs mean more toxicity and the need of closer vigilance. I do not even know if these drugs do interact between them.
The nice thing with hormonal treatment is that newer drugs (second generation) are coming off the drawing board to give us a chance for continuing manipulation. When one fails another may take its place. Let's try to be fit.
Wishing you a continuous success.
Vgama
VGama,
Thanks Caring.
2007 0.02 psa
2008 6.8 psa, 7 out of 12 gleason 4+5, RP, pT2c and after .2psa
2009 1.1 psa, protron radiation, later that year .3psa
2010 1.2 psa MD Anderson N1,M1a start lupron and .3psa
2011 1.4 psa start casodex 50mg mid year 0.6psa, but October 1.2psa and stop Casodex.
2012 2.6 psa January 29 and February 1 start Zytiga February 29 .3psa
Went to VA Hostipal and they will supply the Zytiga. VA blood test .3psa on March16.
The last lab show my AST of 50, platelet count 132,000, testosterone undetectable, CEA 1.4
The doctor's recommended a good diet plan. Increase my exercising. Get off my lazy ****.
Taking 4 250mg Zytiga with 5mg predinsone. The first month I would get up morning and take Zytiga first and 1-2 hours later and take predinsone with rest of my medicine and eat!
The second month I get up eat and take the predinsone and wait 2-3 hours and take Zytiga.
It is alittle bit better eatting first and waiting 2-3 hours for Zytiga.
Yes,I'm sorry you can exercise on this medicine.
I worry about Liver function??
Its very crazy Prostate Cancer, you cut it food source off, and it starts grow it's own! You mutate T-Cell with a drug to hunt these PSA cell down to kill them, BUT they change them self to look different. What kind mutate monster are these Cell of hell. This is just like VC in Vietnam, Mean,hard to kill!0 -
Thanks Ralphralph.townsend1 said:Changes
VGama,
Thanks Caring.
2007 0.02 psa
2008 6.8 psa, 7 out of 12 gleason 4+5, RP, pT2c and after .2psa
2009 1.1 psa, protron radiation, later that year .3psa
2010 1.2 psa MD Anderson N1,M1a start lupron and .3psa
2011 1.4 psa start casodex 50mg mid year 0.6psa, but October 1.2psa and stop Casodex.
2012 2.6 psa January 29 and February 1 start Zytiga February 29 .3psa
Went to VA Hostipal and they will supply the Zytiga. VA blood test .3psa on March16.
The last lab show my AST of 50, platelet count 132,000, testosterone undetectable, CEA 1.4
The doctor's recommended a good diet plan. Increase my exercising. Get off my lazy ****.
Taking 4 250mg Zytiga with 5mg predinsone. The first month I would get up morning and take Zytiga first and 1-2 hours later and take predinsone with rest of my medicine and eat!
The second month I get up eat and take the predinsone and wait 2-3 hours and take Zytiga.
It is alittle bit better eatting first and waiting 2-3 hours for Zytiga.
Yes,I'm sorry you can exercise on this medicine.
I worry about Liver function??
Its very crazy Prostate Cancer, you cut it food source off, and it starts grow it's own! You mutate T-Cell with a drug to hunt these PSA cell down to kill them, BUT they change them self to look different. What kind mutate monster are these Cell of hell. This is just like VC in Vietnam, Mean,hard to kill!
Ralph
This is wonderful. Thanks for the post.
Yes, the cancer is a monster but you have knocked it down. Hopefully it will be for a very long time.
Just curious about other medicines you are taking with prednisone. What about Lupron, is it a 3-month shot?
Regards.
VGama0 -
4 monthVascodaGama said:Thanks Ralph
Ralph
This is wonderful. Thanks for the post.
Yes, the cancer is a monster but you have knocked it down. Hopefully it will be for a very long time.
Just curious about other medicines you are taking with prednisone. What about Lupron, is it a 3-month shot?
Regards.
VGama
Baby Aspirin
Caredilol 12.5 X2
Lyrica 600 mg
Quinapril 20mg
Simvastatin 40mg
Vitamin D0 -
Thanks againralph.townsend1 said:4 month
Baby Aspirin
Caredilol 12.5 X2
Lyrica 600 mg
Quinapril 20mg
Simvastatin 40mg
Vitamin D
Thanks again.
VG0 -
question concerning treatment
I noticed that there is a clinical trial at MDAnderson which involves Abiraterone Acetate (Zytiga) and Enzalutamide (Xtandi) and Prednisone to help prevent side effects. It is called 2012-0083. Did you participate in this trial and if so what were your learnings experience.
I am now at the point of needing to decide what to do next. RP in 2004, SRT in 2009 at psa, 0.31. Went to less than 0.05 and now is doubling after 5 months. Psa is currently 1.12.
Any latest thoughts to share with your treatment and MDAnderson in general. I live in North Texas but very familiar with the Houston area.
Jdwadenc
0 -
0083 Clinical trialjdwadenc said:question concerning treatment
I noticed that there is a clinical trial at MDAnderson which involves Abiraterone Acetate (Zytiga) and Enzalutamide (Xtandi) and Prednisone to help prevent side effects. It is called 2012-0083. Did you participate in this trial and if so what were your learnings experience.
I am now at the point of needing to decide what to do next. RP in 2004, SRT in 2009 at psa, 0.31. Went to less than 0.05 and now is doubling after 5 months. Psa is currently 1.12.
Any latest thoughts to share with your treatment and MDAnderson in general. I live in North Texas but very familiar with the Houston area.
Jdwadenc
JDwadenc
I hope Ralf reads your post. Try mailing him a private note.
In your other thread (http://csn.cancer.org/node/261816) you discussed about the "Casodex and MK2206" clinical trial. In this post you talk about the "Abiraterone Acetate (Zytiga) and Enzalutamide (Xtandi)" and in my opinion this is must better for your situation. The problem is that you need to find a way (doctor) that would manage to accept your participation in the trial. This trial is for hormonal refractory patients (castration resistant PCa), however, many benefit from the combo treatment and some oncologists use it off label in patients of your status.
Here is the link to details of the trial; http://clinicaltrials.gov/ct2/show/NCT01650194Best
VG
0 -
Clinical TrialVascodaGama said:0083 Clinical trial
JDwadenc
I hope Ralf reads your post. Try mailing him a private note.
In your other thread (http://csn.cancer.org/node/261816) you discussed about the "Casodex and MK2206" clinical trial. In this post you talk about the "Abiraterone Acetate (Zytiga) and Enzalutamide (Xtandi)" and in my opinion this is must better for your situation. The problem is that you need to find a way (doctor) that would manage to accept your participation in the trial. This trial is for hormonal refractory patients (castration resistant PCa), however, many benefit from the combo treatment and some oncologists use it off label in patients of your status.
Here is the link to details of the trial; http://clinicaltrials.gov/ct2/show/NCT01650194Best
VG
Since I am located 200 miles from Houston and MD Anderson Cancer Center, I noticed that this is an OPEN Phase 2 trial. Hopefully I will get an appointment in September aat MD for a second opinion for my future treatment. When I read about Zytiga and Xtandi in general, which are part of this trial, you are correct that they are for hormonal refractory patients. I have a close friend who was working in Kuwait and did not monitor his PSA properly after 3 years of a RP, found on a home visit that his PSA went from 0.1 to a value of 9. Some cancer found in his leg on BS. Started the typical treatment of Casodex(3 weeks) and Lupron periodic injections and PSA value is now less than 0.1. What about all of us between 1, rising PSAV and hopefully, bone cancer has not revealed itself?
You mentioned earlier about AD-3 treatment. Does this mean, 150 mg of Casodex daily? If I was accepted into the other trial, I might be RANDOMIZED into the 50 mg per day group which may not be the best option, as you stated. In the 2206 trial the bone scan is a STANDARD bone scan and the a CT Scan of Abdomen/Pelvis area. Perhaps, as you stated then are not the latest scanning tools.
JDW
0 -
Consulting at MDA
You are right.
Casodex alone (which ever 50 or 150 mg daily) may not be benefitial to your case. ADT3 stands for androgen deprivation therapy with three blockades done with the combination of three drugs. An agonist like Lupron plus an antiandrogene like Casodex plus a 5- Alfa redutacse inhibitor like Avodart. These three conbine well in controlling aggressive forms of cancer. In your case, without prostate you may skip the 5-ARI.
In any case, this trial with Zytiga plus Xtandi seems to be very good. Just try to get the opinion of the doctor you are consulting at MDA to find about participation possibility.
Wishing you luck in your journey.
VG
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