Clinical trials with Zytiga

[Parscore]

Ok I am not good at research but gave it a shot. Are there any clinical trials ongoing or completed using less than 1,000 mg of Zytiga. as the maximum daily.

[Tall_Allen]

There were some trials at lower doses with food, showing that the amount that got into the blood could be similar. But that is only to save money. Now with cheap generic ($220/mo) there is no reason to guess.

The 1000mg was arrived at in early dose-finding trials that found it gave the best balance of effectiveness and side effects.

[Stephen399b in reply to Tall_Allen]

I have heard reference to generic aberaterone from you before. Do you know if it is available outside the USA?Thanks

[Concerned-wife in reply to Stephen399b]

I noticed you are from the UK. You might wish to contact the group mentioned in the enclosed article, which seems to say it was added to NHS coverage. prostatecanceruk.org/about-...

[Stephen399b in reply to Concerned-wife]

Thank you. Unfortunately this was only in the height of the pandemic and since then NICE has refused to approve Abiraterone for general use in England, although Wales and Scotland are different.Stephen

[Proflac in reply to Stephen399b]

Sorry to hear that NICE have withdrawn Zytiga from England again. My husband was given this as the Covid epidemic first started and all chemo was cancelled (chemo being the SOC that the NHS in England approved for his stage (Metastatic hormone sensitive – distant mets in mediastinal, no visible bone mets – but on a bog standard bone scan only). He first had Xtandi (as per NHS protocol) but it completely floored him, so they were allowed to move him to Zytiga. We were, in fact, at the point of paying for it ourselves if this had not happened, since our reading of the various studies (and helpful posts on this site) suggested that it was probably the optimum treatment for my husband. He is still being prescribed Zytiga on the NHS (+prednisone), I guess on the grounds that its not right to withdraw this treatment once started. However, I hear from our nurse specialist that Abi will come off patent in Europe probably in September 2022 (not sure how to check this). Of course, its not clear if the UK is still ‘Europe’ since Brexit! If this is the case, and if abi is thought to be the optimum treatment for you I guess you could consider self-funding until then. Not cheap though, as you know, and it will depend on your circumstances but it could be a med with a chance to extend your life. If money is tight, you could make it cheaper by using the ‘with food’ option – but see TA’s posts on this – it can be tricky to get it right (though there is some advice on the site about how to do this too). Alternatively, you could look at getting a supply of generic from India or elsewhere. I am not sure how to do this in terms of the NHS but I feel it must be possible. Maybe a private consultation here in the UK? Hopefully your consultant or nurse specialist might help. If not then call the specialist nurse helpline at Prostate Cancer UK and ask them – they are an amazing resource that I can’t recommend highly enough. It does seem so unfair that its available in Wales and Scotland. Maybe NICE will think again, but in the meantime I wish you luck with this. For the record, husband’s mets ‘resolved’ on the subsequent bog standard CT scan, but we know others are out there somewhere! so carrying on with ADT and Zytiga. Also, for the record, it makes him mega exhausted - but he’s still alive, PSA bobbling around .5 to .8 and no pain, and hopefully you won’t suffer quite so badly from the SE. Quite likely that a lot of his exhaustion is from the ADT anyhow (decapeptyl) though it did get a degree or two worse on the Abi.

[Stephen399b in reply to Proflac]

Thank you so much for such an informative response.I am in the situation that I have been on Zytiga +prednisolone as a private patient. However I have now retired from work and so my health insurance will stop soon. I am hoping that because I have been on it for 12 months already that the NHS will understand that it is working and to change would be dangerous. Your comment about this, gives me hope.

I assume that once it comes off patent and there are generic versions, that NICE will approve it??

It is keeping my PSA at<0.1 although I have now had 3 PSMA PET scans and whilst the prostate activity has gone down considerably, the metastases activity is growing. This is a worry, especially as I doubt I will be able to have PSMA PET scans on the NHS?

Anyway, you have been really helpful and very best wishes to you both

Stephen

[Proflac in reply to Stephen399b]

Thanks Steven. Dorry didn't realise that. Re the scans, I think it depends where you are as they are just not available (NHS) everywhere but also even where they are they seem to be closely rationed. We have asked for one but no go until PSA rises. Not sure there is a common cut off point but our guy says definitely no below 0.5 and even then I doubt he would order it - or if radiology would do it, until higher. There is a clinical justification for this I think. But your options might be different if you are at a major centre like the Marsden. Good luck. I think you have a fair chance of being able to continue with Zytiga. Glad it's working well for you.

[Stephen399b in reply to Proflac]

We have used the Cobalt centre in Cheltenham. They will do it privately for individuals.Stephen

[Proflac in reply to Stephen399b]

Thanks. That's really useful to know.

[Tall_Allen in reply to Stephen399b]

My understanding is that only the Zytiga brand is available in the UK. Some people get it from India. It is a shame that NICE refuses to approve it in England

[LearnAll]

There is a University of Chicago study...which concluded that 250 mg of Abiraterone with fatty breakfast is equally effective to 1000 mg of Abiraterone empty stomach.Last year, after reading this study, I started using 250 mg Abiraterone with fatty breakfast (I do Intermittent adaptive therapy) . Because I monitor Total T every 2 weeks along with PSA..There has been no difference in effectiveness. ( trial of one) The best part is that I do not need prednisone with 250 mg Abiraterone with fatty breakfast.

[Concerned-wife in reply to LearnAll]

The study was Low-fat meal. Not fatty.uchicagomedicine.org/forefr...

And the study still prescribed prednisone pubmed.ncbi.nlm.nih.gov/295...

[Hidden in reply to Concerned-wife]

The individual is doing "Intermitant Adaptive Therapy". Never take his medical treatment decisions seriously...he is a rogue.

[LearnAll in reply to Concerned-wife]

Right. That study uses low fat meal. My own experience is to use sufficient fat to increase solubility and bio availability. Other than breakfast, my daily fat intake is miniscule. It does not matter if someone curses or uses the word "rougue" for me..I am happy doing what I am doing and lovin it ...Will be 3 years soon since diagnosis.

[HopingForTheBest1]

Go to clinicaltrials.gov for comprehensive of available trials.