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Old 04-06-2011, 08:45 AM   #1
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Lightbulb The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

Here's another of the wonderful advances we learned about at the IMPaCT conference, which I described in its own new thread a couple of weeks ago. This advance is The Prostate Cancer Clinical Trials Consortium (PCCTC for short). This advance is not about a specific drug, treatment, or device; rather, it is about setting up what amounts to a machine for moving drugs, treatments and devices forward from early trials through the Phase III trials needed for approval by the FDA. I first learned about the PCCTC at the first IMPaCT conference in 2007, not long after the PCCTC had been established. Now, four years later, results we need are in hand with a lot more in the works. I'll write about some of the results first, and then tell more about the PCCTC.

In the past five years, there have been:

- 133 Letters of Intent (LOIs, essentially applications for clinical trials to the consortium, as I understand it). Of these 106 were approved, and 27 were rejected.

- These approved LOIs led to:

- 84 clinical trials that were activated;

- 36 trials that are now open and enrolling patients;

- 48 trials that have been completed;

- 8 agents moved to Phase III trials and 9 trials that had negative results (learning what does not work, or what needs to be approached in a different way, is also important;

- evaluation of more than 60 drugs;

- 2,532 patients have been enrolled in the small Phase I and Phase II trials that evaluate safety and tolerability and determine dosing approaches for Phase III trials (that's equal to about 26% of Phase I/II trial enrollees in industry sponsored trials and to about 13% of enrollees in NIH sponsored trials);

- pomegranate research was one of the highlights.

The Prostate Cancer Foundation (PCF), formerly known as CaPCure, was concerned back in the 1990s that the infrastructure for clinical trials was lacking and very expensive. In other words, a researcher or physician with a good idea for treatment was faced with the daunting task of assembling all the works needed for a trial - plan drafting and approval, patient recruitment, patient treatment, patient follow-up, statistical analysis, review board, etc. In 1996 the PCF decided to fund six centers with the requirement that they work together, with Memorial Sloan Kettering in New York City as the leader, under Dr. Howard Scher, MD. In 2004/2005, the DoD's Prostate Cancer Research Program (PCRP) chipped in, and the consortium was expanded to 13 centers.

Approval of drugs for castration resistant prostate cancer has been slow, and the PCCTC is already accelerating approval. In the past 15 years, just 9 drugs have been approved for metastatic, castration resistant prostate cancer:
- to enhance survival: docetaxel, Provenge, cabazitaxel;
- to decrease and control pain: mitozantrone, strontium, and samarium;
- and to boost skeletal health while on treatment: zoledronic acit (Zometa) and denosumab.

The PCCTC was involved with approval trials for FDA approved drugs cabazitaxel (I believe, not sure of DoD program involvement) and denosumab, as well as with successful completion of Phase III trials in the short space of just five years - short in cancer drug approval trial terms - for the drug abiraterone, whose approval is expected in the coming months. Another drug involved with the PCCTC, MDV3100, is looking highly promising.

 
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Old 04-10-2011, 06:09 PM   #2
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Re: The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

There are a number of drugs that are now in or that have recently completed Phase III clinical trials for prostate cancer under the PCCTC. Here is the list:

Abiraterone
ARN-509
Dasatinib
IMC-A12
Ipilimumab
MDV3100
Sunitinib
Tasquinimod
TAK-700
XL-184

It is estimated that some of the drugs have been brought to Phase III development in half the normal time.

Abiraterone acetate seems to be the number one star. The newsletter states that "It blocks the synthesis of androgens in the testes, in the adrenal gland, and in prostate tumors through inhibition of the enzyme CYP17.

More information is provided in the CDMRP's newsletter "PCRPerspectives", Vol. 3, Nukmber 1, February 2011. The newsletter also provides a graphic that shows how the drugs affect various pathways for turning on the androgen receptors and fueling the cancer.

 
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Old 04-11-2011, 01:53 AM   #3
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Re: The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

Wonderful news.
Thanks Jim for posting about the details of PCCTC.
I have falling in love with Abiraterone and will "marry" it.
Regards
Baptista

 
Old 04-14-2011, 10:07 AM   #4
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Re: The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

Hi there...back from our much needed vacation and it was wonderful. We had the chance to forget about Irv's health issues and he's been feeling wonderful. He's been going to the gym every day and he's lost about 20 pounds. He isn't experiencing any nasty side effects from the medication yet, except for, perhaps, further loss of libido.

The update on Irv is that the medical oncologist was very displeased that he went on triple blockade and sent a letter to his GP making that feeling known. He said that it will prevent him from qualifying for any clinical trials and he went on to comment on intermittent androgen blockade, as though this was not an option with triple blockade, which, of course, it is, except for the Avodart which would continue.

The GP asked Irv to come in and discuss these things with him but we're still comfortable with the triple blockade. My main concern is the possibility that they may refuse to give Irv a fourth Zoladex injection should he require it, because they only believe in the three injections before taking a break. I guess we'll deal with it when we get to that point.

As for the Abiraterone, my understanding is that it is a second line therapy and is considered after the cancer becomes hormone refractory. I just wanted to know if you think we are still on the right path....triple blockade and, failing that, then we move towards Abiraterone???

I'll look forward to hearing back on this. It was nice to get away, but I'm glad I have this board to come back to whenever I need.

Rhonda

Last edited by honda50; 04-14-2011 at 10:09 AM.

 
Old 04-14-2011, 07:03 PM   #5
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Re: The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

Hi Rhonda,

I'm glad to see that you both had a grand vacation! That's the way to live! I'll insert some comments in green.


[QUOTE=honda50;4730466]Hi there...back from our much needed vacation and it was wonderful. We had the chance to forget about Irv's health issues and he's been feeling wonderful. He's been going to the gym every day and he's lost about 20 pounds. He isn't experiencing any nasty side effects from the medication yet, except for, perhaps, further loss of libido.[QUOTE]

I'll tip my hat to Irv. It's not easy to maintain an exercise routine, but he is evidence of how effective it can be.

Quote:
The update on Irv is that the medical oncologist was very displeased that he went on triple blockade and sent a letter to his GP making that feeling known. He said that it will prevent him from qualifying for any clinical trials and he went on to comment on intermittent androgen blockade, as though this was not an option with triple blockade, which, of course, it is, except for the Avodart which would continue.
Was this Dr. Fleshner who complained? It's sad that the oncologist reacted that way. I'm surprised about his comment on the trials; it's probably an emotional over reaction. Actually, unless the trial protocol rules out patients taking Avodart, it would not be a problem.

Quote:
The GP asked Irv to come in and discuss these things with him but we're still comfortable with the triple blockade. My main concern is the possibility that they may refuse to give Irv a fourth Zoladex injection should he require it, because they only believe in the three injections before taking a break. I guess we'll deal with it when we get to that point.
That is still a judgment call. I believe that getting below 0.05 is worthwhile, and there is some research documenting that. However, one school of thought is that nine months is enough. For now, as you wrote, it is an issue for the future. Maybe when they see a great response they will ease up a bit.

Quote:
As for the Abiraterone, my understanding is that it is a second line therapy and is considered after the cancer becomes hormone refractory. I just wanted to know if you think we are still on the right path....triple blockade and, failing that, then we move towards Abiraterone???
Abiraterone could become an option, but trading ketoconazole (with hydrocortisone to counteract a side effect) for the bicalutamide would probably be a preferable first shot at second line therapy. What's more, ketoconazole's use for prostate cancer was discovered at Princess Margaret, if my memory is serving me well. Abiraterone might be a later option, or perhaps it will emerge as the favorite second line approach.

Quote:
I'll look forward to hearing back on this. It was nice to get away, but I'm glad I have this board to come back to whenever I need.

Rhonda
I hope that vacation mood and the memories will last for you.

Take care,

Jim

 
Old 04-14-2011, 11:49 PM   #6
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Re: The Prostate Cancer Clinical Trials Consortium (IMPaCT Conference)

[QUOTE=IADT3since2000;4730933]Hi Rhonda,

I'm glad to see that you both had a grand vacation! That's the way to live! I'll insert some comments in green.


Thanks, Jim...It was a much needed break, indeed...and did wonders for us.


I'll tip my hat to Irv. It's not easy to maintain an exercise routine, but he is evidence of how effective it can be.

Well, so far, so good and we'll hope for continued success.

Was this Dr. Fleshner who complained? It's sad that the oncologist reacted that way. I'm surprised about his comment on the trials; it's probably an emotional over reaction. Actually, unless the trial protocol rules out patients taking Avodart, it would not be a problem.

It was actually Dr. Tannock, the medical oncologist who was so bent out of shape over our decision. He claims that, taking the triple blockade will make him ineligible for future clinical trials. We really can't worry about that, especially since we know of one man who was involved in three clinical trials and, the last we saw of him, his PSA was at 330 and rising out of control and he said that, technically, he'll be dead in 6 months. I hope that isn't the case but it gave me less confidence in the idea of putting all hope and confidence in these clinical trials.


That is still a judgment call. I believe that getting below 0.05 is worthwhile, and there is some research documenting that. However, one school of thought is that nine months is enough. For now, as you wrote, it is an issue for the future. Maybe when they see a great response they will ease up a bit.

I doubt it, honestly...I think that they won't put too much emphasis on a good response this early in the game as they believe that single blockade would do the same thing.



Abiraterone could become an option, but trading ketoconazole (with hydrocortisone to counteract a side effect) for the bicalutamide would probably be a preferable first shot at second line therapy. What's more, ketoconazole's use for prostate cancer was discovered at Princess Margaret, if my memory is serving me well. Abiraterone might be a later option, or perhaps it will emerge as the favorite second line approach.

I'm hoping that the first line therapy gives Irv the good results that you've experienced for many years. Perhaps, then, when that fails, there will be all kinds of new therapies and maybe even a cure or lifetime control.



I hope that vacation mood and the memories will last for you.

Thanks, Jim. I hope that Irv's next PSA test brings good results so we can continue to be positive.

Rhonda

Last edited by honda50; 04-14-2011 at 11:50 PM.

 
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