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Old 12-05-2011, 01:16 AM   #1
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Ortoneral

Has anybody heard of trials of "ortoneral"? Doc says that it is a generic of arbiterone, says that they are doing trials at Auckland, NZ and that there is possibility of getting my husband on them.
I have searched the net and have been unable to come up with anything.
Keep up hte good fight!
Ann

 
Old 12-05-2011, 04:55 AM   #2
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Re: Ortoneral

Ann

I never heard of such drug but the “supplier” of Zytiga (abiraterone acetate) in EU is Janssen-Cilag (J&J) which holds offices in NZ.
You could try to contact them to find about their Zytiga in NZ or you may request for details on action of the drug (Ortoneral) offered by the doctor and compare with those of abiraterone acetate. This should be an inhibitor of the enzyme CYP17 (17α-hydroxylase/C17,20 lyase). Its main purpose is to inhibit a protein (cytochrome p450) that is involved in testosterone production.

The best.
Baptista

 
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Old 12-08-2011, 04:58 PM   #3
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Re: Ortoneral

Hi Ann,

What your husband's doctor said makes no sense to me. Aberaterone IS the technical name for Zytiga, as Baptista noted, and there is no generic equivalent. Zytiga is a new drug, and it will be more than about a dozen years before companies other than the patent holder are permitted to manufacture equivalent generic versions.

In the US doctors sometimes try to steer patients toward trials in which they have a research or even a personal economic interest. Sometimes they are even paid a fee for each patient they refer. At times this is also beneficial to us patients. However, it can be highly contrary to our interests if we are used as guinea pigs for untried treatments when effective treatments are available.

Your husband's doctor may be doing his best for him, but I'm skeptical. Is it possible for your husband to get another medical opinion from a doctor not associated with the current doctor?

Take care,

Jim

 
Old 12-09-2011, 11:30 AM   #4
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Re: Ortoneral

Orteronel, or TAK-700, is a very promising new drug developed by Millennium Pharmaceuticals (a division of Takeda). It is an oral, androgen synthesis inhibitor that selectively inhibits the 17-alpha-hydroxylase enzyme and C (17,20)-lyase. This enzyme, which is present in both the testes and adrenal glands, is central to the production of steroidal androgens. Synthesis of androgens outside the testes contributes to disease progression in castration-resistant prostate cancer (CRPC). It acts similarly to the old standby ketoconazole, the recently approved abiraterone (Zytiga), and two other drugs in clinical trials now: MDV-3100 and TOK-001.

Orteronel may not have the toxicity of ketoconazole, and may continue to work longer than either Zytiga or ketoconazole. IMHO, it is one of the best new drug prospects out there and I would jump at the chance to get it now on a clinical trial. A downside of a double-blind placebo-controlled clinical trial like this is that the placebo is only getting prednisone and Lupron (or similar GnRH agonist, if he has not undergone castration). Since a primary endpoint of the study is disease progression, he will be able to try other therapies like chemo or radiotherapy then if that should happen.

You can read more about the clinical trial here:
http://clinicaltrials.gov/ct2/show/study/NCT01193244

- Allen

 
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Old 12-09-2011, 05:33 PM   #5
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Re: Ortoneral

Tall Allen,

Thanks for pointing me in the right direction.
Ray's next visit to doc is 16th January, so very useful to have all the info.

Ann

 
Old 01-31-2012, 06:19 PM   #6
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Re: Ortoneral

Hi all,
Just to update everyone how Ray is making out.
He was unable to get onto the above trial, however he started 2mg diethylstillbestrol plus 2mg warfarin on the 20th January. PSA at that time was at 49, doubling every 2 months .
Blood work done yesterday(31st) shows PSA now at 36 , will have bloods done again in a month, so I am cautiously optimistic that we will see another drop. No scans done at this stage. Will ask when we go back on 12th March, as Ray has had some mid-back pain intermitently.
Thanks to all,

Wish everyone well.
Ann

 
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Old 01-31-2012, 06:52 PM   #7
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Re: Ortoneral

I'm sorry to hear he could not get on the Orteronel trial.

As you know, especially if you know about its past use in cattle, DES is an estrogen which can cause excessive clotting, which is why he's also taking warfarin. If an estrogen patch is available there, he may not need the warfarin. Is he taking any other androgen suppressors as well (e.g., leuprolide, bicalutamide, finasteride/dutasteride, abiraterone, ketoconazole)?

I hope the back pain turns out to be only that.

- Allen

 
Old 01-31-2012, 08:13 PM   #8
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Re: Ortoneral

Hi Allen,
Thanks for your encouragement.
Here in NZ we have been unable to access patches.
The only concern I have is that the bloods show a rise in testosterone from 0.4 to 1 and my gut feeling is that less is better.
Over the past 7.5 years, Ray has been on bicultamide, siterone and then flutamide, coming off flutamide in November, 2010 with a rising PSA. Also 3 years ago he had an orchidectomy as he had got to the stage of not being able to cope with the injections any more.
I have tried in the past to get finesteride for Ray, do you think that this is still an option that could go with the DES, 'cause I have wondered if it was worth pursuing again....

Once again, thanks.
Ann

 
Old 01-31-2012, 10:22 PM   #9
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Re: Ortoneral

Ann, I can't think of any reason that you can't add finasteride or dutasteride (5-a-reductase inhibitors that prevent the metabolism of testosterone into DHT, a more potent androgen). Some doctors are afraid it might encourage development of higher grade disease, but the risk is really very small if there is any at all. Because finasteride blocks the metabolism of testosterone into DHT, and the DES might discourage the metabolism of testosterone into estrogen, so with the two major metabolic routes blocked, testosterone levels will probably accumulate and increase. But since testosterone is a much less potent androgen than DHT, that might be the lesser of the two evils.

However, I suspect that that would not be enough to block DHT. The reason is that in castrate-resistant PC, DHT is not created from testosterone by 5-a-reductase (which would ordinarily be blocked by finasteride). Instead DHT is created from within the tumor and from the adrenal gland from different steroids entirely. Ketoconazole, or the new drug abiraterone, are very good at stopping the non-testicular sources of testosterone. Ketoconazole is an old drug that is readily available everywhere.

I checked clinical trials in NZ and saw that they are recruiting for a Phase III trial of tasquinimod, which has shown great promise in preventing metastases in castrate-resistant tumors. They would probably require he come off DES/warfarin in order to participate:
http://clinicaltrials.gov/ct2/show/NCT01234311

Thanks for keeping us apprised, and I hope you will continue to do so.

- Allen

 
Old 02-01-2012, 02:14 PM   #10
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Re: Ortoneral

Thanks Allen,
Will certainly do so.


Ann

 
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