Apalutamide (previously known as ARN-509) is an androgen receptor [AR] antagonist similar to Enzalutamide [Xtandi], except that it has "greater potency and several-fold reduced central nervous system permeation" [1].
The SPARTAN trial took high-risk men without mets & randomized them (2:1) to treatment or placebo. These were men likely to develop mets, & the aim was to delay that. (Selection was based on a PSA doubling time of less than 5 months.)
"Patients randomized to apalutamide had a median metastasis-free survival (MFS) of 40.5 months versus 16.2 months for placebo treatment." [2] A two year delay.
The "PROSPER trial showed a median MFS of 37 months for men treated enzalutamide (Xtandi) versus 15 months with placebo." [2]
Inclusion criterion: "PSA doubling time ≤ 10 months" See [3] for all criteria.
Thank You Patrick, It seems it will be approved this spring in Non metastatic, My hope is it will be available with compassionate use for metastatic guys, good news on the horizon!
I know it's the scientific method, but anyone else feel bad for the placebo people?
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Cant say I do. Most trials fail, so they are only missing the bad side effects.
If the experimenters were sure that the medicine worked, it would not be a trial.
So you are not getting something that does not work.
If it is "life or death", that's "compassionate use", but that is not always available of course. In a sense I feel bad for everybody who dies, but that's everybody.
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I'd say that trials are launched for promising new treatments. A placebo is a non-treatment. Time wasted on non-treatment when you are dealing with cancer seems cruel. Yeah there are risks with any new treatment. Non-treatment is 100% risk.
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I know what you mean. If the trial prevents you from trying anything else, then he person on the trial who gets a placebo, if the trial endpoint is overall survival, is wasting his last bullet. But I hope that case does not occur, and of course, you can leave the trial at anytimme. So there is that. so it is not "cruel", in any sense except that death is cruel.
The new drug application for Apalutamide is for non-metastatic castrate-resistant PCa. Restricting it to non-metastatic PCa seems odd. Does anyone understand the rationale for this restriction?
When xtandi and zytiga were first approved they were for post chemo patients, but that soon changed, and guys could get it before chemo. So I think the same will be true for this drug and wether you are metastatic or not.
Makes sense for Apalutamide to initially compete where Xtandi is not already established, IMO. & following approval for non-mCRPC, we would soon see it being used for other situations.
Yes, micro Mets ,like I also have, presents a real problem in that it represents a serious systemic threat, but each individual met cannot be seen with current technology. So, if can’t be seen ,prevents you from qualifying for treatment that requires evidence, and yet, there are too many Mets to kill them with radiograhic or surgical attack.
If you let PSA rise, you can then light up scan like a Christmas tree, putting you in an even more dangerous position. On other hand, someone with 2 or 3 larger Mets with higher PSA can potentially have those removed with surgery or killed with radiation.
I think part of the reason for labeling it for non-mets is pure corporate economics. I don't want to sound like a conspiracy theorist, but Janssen Bio makes both these and Zytiga. Why would they basterdize their own jewel - Zytiga - after all the fanrafe in 2017 ASCO , given how much they invested in it, and how expensive the drug currently is?
But now we can be sure there will be trials comparing the two - or three if you include Xtandi.
I am in the titan trial ...i have been for 23 cycles....double blind study....but i also have a ductal variant pc...wich is suppose to preclude me from being in study if u read trial protocol...i am also suppose to get paid 55.00 a visit havent in a year...but i do it for cat and bone scans evry 3 mos. No cost to me ...no insurance so willing lab rat....psa>.01...mets stable....but the lupron could do that....as i was on for 6 mos prior...same stats....fight on.....f$#k cancer...bw
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Enzalutamide plus leuprolide reduces risk of metastasis in nonmetastatic HSPC men-from Urology Times, 29 Apr 2023
Enzalutamide Product info, FYI
Xtandi (enzalutamide) alone is superior to ADT alone at preventing metastases in "high-risk" recurrent men
