Apalutamide for Metastatic Castration... - Advanced Prostate...

Advanced Prostate Cancer

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Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

snoraste profile image
23 Replies

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."

practiceupdate.com/C/84533/...

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snoraste
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23 Replies
Blair77 profile image
Blair77

Has this drug been tested in the castrate resistance setting?

snoraste profile image
snoraste in reply toBlair77

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.

pilot52 profile image
pilot52 in reply tosnoraste

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....

RonnyBaby profile image
RonnyBaby

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) ....

6357axbz profile image
6357axbz in reply toRonnyBaby

Didn’t they tell you whether or not you received Apalutamide after you quit the trial? I would think they had an obligation to do that.

RonnyBaby profile image
RonnyBaby in reply to6357axbz

NO, they don't disclose that info.

The trial is still ongoing and the outcome will be determined YEARS later, after follow up.

I am still doing blood work for 'them' as a 'thank you / courtesy' for being allowed to participate in the first place.

It is the least I can do - the blood goes to the sponsor for testing and record keeping AND voluntary follow up in the future.

6357axbz profile image
6357axbz in reply toRonnyBaby

It just seems if some other medical condition arose the docs would want to know what medications you had been taking.

monte1111 profile image
monte1111 in reply to6357axbz

Yeah. I know nothing, but really is odd. If offered another trial, how can you give them a list of what you've already tried?

RonnyBaby profile image
RonnyBaby in reply to6357axbz

NO, I don't see it that way. The trial is sponsored by a foreign entity.

Mikeski profile image
Mikeski in reply toRonnyBaby

Ronny, could you elaborate on the major side effects ? I’m headed in that direction soon

RonnyBaby profile image
RonnyBaby in reply toMikeski

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.

I don't want to scare people for nothin' ....

Mikeski profile image
Mikeski in reply toRonnyBaby

Sorry to hear you suffered almost all listed side effects. Good luck and God bless on your fight.

Fitzbruce1 profile image
Fitzbruce1 in reply toRonnyBaby

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?

RonnyBaby profile image
RonnyBaby in reply toFitzbruce1

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 !!!

I also watch what I eat and exercise regularly.

I'm a grumpy 67 ta boot @#$%

Not really ....

Fitzbruce1 profile image
Fitzbruce1 in reply toRonnyBaby

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.

68 n still gettin ‘er done! Thanks again !

RonnyBaby profile image
RonnyBaby in reply toFitzbruce1

It sounds like you're having the time of your life.

Good for you - it's nice to know you can still rock !

FYI - I did some private paid, third party oncology blood work that I

use as a guideline to use effective (identified by the lab) natural

herbs and supplements that actually help with apoptosis and/or

some other preventative action.

You can fight back by stopping the formation of blood supplies or

you can help inhibit the deposition of tumorous material(s) in an

overall form of intervention.

There's more than one way to fight back, because there are more than

one type of cancer cell(s) and more than one variable to consider.

Fitzbruce1 profile image
Fitzbruce1 in reply toRonnyBaby

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!?

6357axbz profile image
6357axbz

How does apalutamide compare with abiraterone for mCSPCa?

snoraste profile image
snoraste in reply to6357axbz

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.

6357axbz profile image
6357axbz in reply tosnoraste

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

in reply to6357axbz

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

What is aberiterone

Longterm101 profile image
Longterm101

A 9% delta in overall survival is good but I’d like to see a drug that has a much larger margin.

It’s time for big Pharma to develop a drug that makes a significant difference

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