EMBARK trial results reported

[GP24]

Pfizer reported results of the EMBARK trial testing Xtandi+Lupron or Xtandi alone against Lupron+Placebo. Seems that hormone-sensitive patients may be able to choose Xtandi alone and avoid Lupron. This applies to patients who had no metastases on CT/bone scan. Pfizer writes:

The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS [Metastases free survival] for patients treated with XTANDI monotherapy versus placebo plus leuprolide.

pfizer.com/news/press-relea...

[tango65]

It is not surprising that Xtandi (enza) a drug which can treat castration sensitive and castration resistant cancer has a longer progression free survival than leuprolide, a drug which can treat only castration sensitive cancer.

[GP24 in reply to tango65]

Without a phase III trial, doctors will always prescribe the combination of Xtandi+Lupron. Xtandi does not lower the testosterone level, so you avoid many side effects of ADT with Xtandi monotherapy.

[Benkaymel in reply to GP24]

Although Xtandi doesn't lower T, it blocks it's use in the body so won't you still get all of the low T side effects?

[Justfor_ in reply to Benkaymel]

Only side effect is gynaecomastia. No hot flashes, cognitive or bone issues, nothing of that sort.

[CAMPSOUPS in reply to Benkaymel]

Just my personal experience but I swear it to be that of those in the original trials etc.

Compared to Lupron and to Lupron + Zytiga, Xtandi has gifted me (lol) with way more intense hot flashes and a bit more frequent. Cognitive is worse too although I came off of badly tolerated chemo régime a couple months ago.

MO asked me if Xtandi increased my hot flashes knowing that that is a possibility.

[treedown in reply to CAMPSOUPS]

I would have met the entry for this trial. I wanted Daralutamide but Kaiser told my MO they would approve Xtandi but haven't done so officially yet. I'll see how I handle it compared to Zytiga which I did for 2 years without much of an issue other than Lymphocytopenia which could have been caused by radiation or combo. If it is truly just the lack of T that was the issue, mine was <1, than the experience should be similar. If however, the actual drug effects differ, I may be in for a ride and have picked the wrong poison. There is a chance the insurance company will let me switch to Daralutamide if Xtandi gives me too much brain fog as I understand it the former does not cross the blood/brain barrier as the latter does. Guess I'll see. I was hoping to avoid the steroids that come with Zytiga and also the potential drop in white blood cell count I got with it. If I go ahead with the radiation I may hold off on the Xtandi until after just in case. I can't imagine a week or 2 would matter since I will be on something the rest of my life now. Might be time to get snipped.

[CAMPSOUPS in reply to treedown]

Hey buddy I haven't said anything till now but sorry to see you reach this point. You halfway saw it coming you've said but still I thought you might dodge the reoccurrence bullet.

I sound like a broken record but we don't always react the same to treatments. You have your good fitness level going into any treatment. I guess if you end up on Xtandi you will just have to see if its tolerable, see if you want to push for Darolutamide.

[treedown in reply to CAMPSOUPS]

I have known it was there for months and now that I now where its time to take action. Its very comforting to come back here for perspective. Also the great info. Feeling better about my decisions and the risks. I am blessed my starting point and will deal with the results as they come. I am sure to get the call from my RO tomorrow to get the radiation scheduled and I think I am prepared now.

[Benkaymel in reply to CAMPSOUPS]

I'm sure that Xtandi has increased my hot flashes too. It stands to reason since it totally blocks T reception so is stronger than ADT alone. Other than that though I'm tolerating it quite well.

[GP24 in reply to Benkaymel]

You take Xtandi combined with Lupron. This is different to Xtandi without Lupron, which was tested in the Embark trial. This was a three arm trial Xtandi+Lupron, Xtandi alone and Lupron plus placebo. I think the hot flushes were primarily caused by Lupron lowering T and estrogen.

[GP24 in reply to Benkaymel]

Benkaymel,

the male body produces estrogens from testosterone. So you not only have a low T but also a low estrogen level. Several side effects are caused by the lack of estrogen and not by the lack of T. This are hot flushes, bone loss and weight gain.

[Benkaymel in reply to GP24]

Yes I know but the root cause is lack of T leading to lack of estrogen.

[Batman2]

AS I SEE IT, Lupron alone has kept me vertical and my MO is checking my PSA every three months to coincide with a shot of Lupron. We, all of us, are chemically different, what is good for you with no side issues... just may not work at all for me. I believe that keeping my physical condition in shape and eating as though I were on a strict diet to keep my person in the the best shape is a real plus, but that is me. Stay out of the "Box Stores " and buy your food stuff straight from the farm or grow your own. Cut down on everything you are eating now and eat lless.