Not surprising - question is the relative performance vs Abi or Enz (or combination with other drugs).
"TAKE-HOME MESSAGE
The authors of this double-blind, phase III trial randomly assigned 525 patients with metastatic, castration-sensitive prostate cancer to receive apalutamide or placebo, added to ADT. The study allowed for previous treatment for localized disease and previous docetaxel therapy. The radiographic progression–free survival at 24 months was 68.2% in the apalutamide group and 47.5% in the placebo group (HR for radiographic progression or death, 0.48). Overall survival at 24 months was also greater with apalutamide than with placebo (82.4% vs 73.5%, respectively; HR, 0.67).
Adding apalutamide to ADT offered patients with metastatic, castration-sensitive prostate cancer improved overall survival and radiographic progression-free survival when compared with patients receiving ADT plus placebo."
To the best of my knowledge, it's only FDA approved for "non-metastatic" castrate resistant patients. There are a couple of clinical trials for the metastatic patients ongoing.
I believe you are correct...My OC offered both enzalutimide and apalutamide to me being non-met....she ultimately decided on enza....so far my PSA is bouncing around going on 4 months....enza has only been approved for non-met since July....they seem to be going backwards on apalutamide getting non-met approval first....
I was part of a Phase III clinical trial involving Apalutamide.
IT is still ongoing - called Atlas.
To qualify, you needed to have had 'aggressIve / advanced' PCa and no previous treatment(s) or condition(s) that could mess up the results (nmCSPCa).
My staging was T3B (node positive) at the time, although I thought I was Stg 4.
I later discovered, accidentally, by seeing an electronic file of my case that I never understood what advanced aggressive really meant.
That Dx can be fairly broad in scope, which points to a lot of confusion for some who don't know how good/bad they really are, IMO.
The protocol also called for RT, ADT (Lupron) with a placebo offered instead of Apalutamide, in a double blind setting. This was a 'combo' approach to test for an aggressive treatment / intervention at an 'earlier' stage than previous protocols would have been used.
The duration is / was 28 cycles (about 4 weeks each).
It is possible that I received 'Apa' for about 12 months.
I QUIT the trial when the overall side effects simply drove me nutz !!!
It is worthy of note that the side effects did NOT improve, suggesting that I got the placebo, OR, the culprit was Lupron (my best guess is the Lupron).
I'll never know 'what if', but thankfully, today, I'm undetectable (< 0.02) for about 1 year moving forward. I'm prepared to roll with the punches, while fighting back with supplements and medical cannabis as my situation dictates. I get MAJOR blood work every 3 months to look at the bigger picture.
Right now, I'm working on the improvement in my immune system. Most of my blood work parameters are in the normal range, as I continue with my ADT withdrawal.
The timeline for my 'recovery' from ADT is NEXT spring.
Typically, the time spent on ADT = the withdrawal time.
I hope I never have to do Lupron / ADT again - in the meantime, I watch and wait (2.5 yrs post Dx) ....
If you consult the most common side effects that are freely published, you could say that it ALL seemed to happen to me.
For example, hot flashes, 'pot belly' / loss of muscle mass, identity crisis / mind @#ck / mental fog / insomnia / loss of interest in food / life / sex (totally NO libido), ED, crying for no reason - for a long period of time / emotionally out of control / suicidal, shrinking testicles AND a lot more than that .....
Some men don't get it as bad as I did, because there are several / certain factors to consider.
There's something else I should mention - I have a weird genetic reaction to some drugs - ask my Mom - we are 'contrarians' - I am NOT like everybody else.
Good for you - .02 psa! Any advice on improving the immune system? My white blood cell count is low so I need to work on it. I go to the gym 3 days a week, paddle board almost every day and try to eat healthy. PSA is also .02. Any recommendations?
My undetectable level is < 0.02 - worth mentioning the 'less than', which is the bottom end of the sensitivity of the test instrumentation.
You also mention the whiten cells / blood count etc .. being 'low'.
In my case, ADT caused some anemia, which is quite common. The bone marrow is affected. The marrow is the primary source / factory of blood cell production.
My 'T' cells are low (about 50% on the scale). All other counts and numbers (red and white) are good / within normal parameters.
I'm working with my Naturo to re-balance my immune system.
Supplementation is the order of the day, while realizing that it will take months (up to 1 year to withdraw from the (my) ADT I took for 16 total months.
I would suggest that you get (re)tested every 3 months (total blood work) to watch what is happening. If you haven't done so, you need to establish base lines and reference points.
What to supplement ?
Deep immune 'tonics', reishi muchrooms, quercetin, B complex, C & D vitamins,
omega 3 (fish oil), curcummin, green tea (young green chinese c\w high EGCCs), dandelion root tea and collagen peptides (marine).
I also use medical cannabis.
High potency CBD oil / tincture for daytime AND an Indica hybrid at night with THC for insomnia.
The tinctures are made with MCT and/or Olive oil for ease of use with no risk of exploding anything !!!
Thanks so much for the detailed answer. I am doing the B,C, D, Curcumin, fish oil, and green tea. I also get vit C infusions n have dabbled w cbd. The rest I will look in to.
I have been luckier than you on the side effects. Hot flashes were the worst and they aren’t that bad anymore. The sudden crying n feeling sorry for myself can be pretty embarrassing. I am doing a lot of traveling, ski trips this winter to Montana and Colorado, scuba in Grand Cayman, a week on the Maine coast and just drove my Z06 on the Sebring Race Track. Going on dirt bike motorcycles in August to ride the mountain logging roads in NW Montana.
I did the Greece test and the Color test. The Greece gave some recommendations and the Color told me that I don’t have any gene mutations. After that I use this site for ideas. I get a weekly vit C infusion, take vit E, D, C , B, fish oil, Coq-10 and Curcumin. After 10 months in this new world, PSA of .02 and a T of 16. I have over 20 bone Mets but I am active for a 68 year old. Went skiing in Colorado n Montana this winter, scuba in Grand Cayman , drove my Z06 on the Sebring Race track, fishing n duck hunting in Louisiana etc.
“Stopping the formation of blood supplies” - could you elaborate?
“Inhibit the deposition of tumorous materials” h’mmm help!?
Long term clinical differences are being investigated now in a couple of trials. From what I’ve heard so far, it cause far less brain fog compared to Abi.
Interesting. I added abiraterone to my Lupron two months ago. ZERO “brain fog” from either one. Just the hot flashes which are a non issue. Those are from the Lupron, not the abiraterone
Monitor yourself and at the 1 year point tell me if you don’t have forgetfulness and just can’t find words. I have that problem and I guess I could have the beginnings of dementia but I say it is the drugs
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