EMBARK trial results reported - Advanced Prostate...

Advanced Prostate Cancer

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EMBARK trial results reported

GP24 profile image
GP24
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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...

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GP24
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tango65 profile image
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 profile image
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 profile image
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_ profile image
Justfor_ in reply to Benkaymel

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

CAMPSOUPS profile image
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 profile image
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 profile image
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 profile image
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 profile image
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 profile image
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 profile image
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 profile image
Benkaymel in reply to GP24

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

Batman2 profile image
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.

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