FDA Grants Priority Review to Apaluta... - Advanced Prostate...

Advanced Prostate Cancer

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FDA Grants Priority Review to Apalutamide ...

pjoshea13 profile image
15 Replies

... based on data from the phase III SPARTAN trial (ARN-509-003)

News item [1].

Apalutamide may be the successor to Enzalutamide [Xtandi].

"It is similar to enzalutamide both structurally and pharmacologically, acting as a selective competitive antagonist of the androgen receptor (AR), but shows some advantages, including greater potency and several-fold reduced central nervous system permeation." [2]

-Patrick

[1] oncnursingnews.com/web-excl...

[2] en.wikipedia.org/wiki/Apalu...

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pjoshea13 profile image
pjoshea13
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YostConner profile image
YostConner

Good news! It looks like the target is men with non-metastatic CRPC. I like the idea of being able to attack the beast early with these more powerful drugs that did not exist when I was diagnosed.

Neal-Snyder profile image
Neal-Snyder in reply to YostConner

I think the idea is to use it preferentially before metastases, but they included men with limited bone or soft tissue mets.

Neal-Snyder profile image
Neal-Snyder

Hi Patrick,

Thank you for this, & all of your diligence & generosity.

I have 2 questions. They aren't answered by the 2 references, so you may not have any further info.

1. Would a guy who previously had, or is having, enzalutamide be eligible? Maybe that's an FDA determination.

2. What do you know about darolutamide, mentioned as a newer drug? I suppose that suggests it's not as far along in the pipeline.

Thanks again, & Happy New Year!

Neal

pjoshea13 profile image
pjoshea13 in reply to Neal-Snyder

Neal,

Happy New Year to you too!

We would need a study to confirm that there is benefit after enzalutamide resistance has occured. It is however, & alas, structurally similar to enzalutamide. Which suggests that the same resistant AR splice variants would emerge in a similar timeframe.

As de Bono has suggested, these powerful newer drugs need partner drugs that inhibit resistance.

(Can't speak to darolutamide.)

-Patrick

Neal-Snyder profile image
Neal-Snyder in reply to pjoshea13

Thank you very much, Patrick. What you say makes complete sense, so I can cross apalutamide off the list of drugs that may be in my future. I hope darolutamine will be a possible option for me.

Neal

Neal-Snyder profile image
Neal-Snyder

Hi Nal,

I certainly would have liked to be on T at some point since I started Lupron,

Have you been on Xtandi? I'm on it, & having more fatigue than from any other med. I'm down from 4 softgels to 3, but it's still pretty powerful. I passed out last night before an exciting 3rd quarter that my Golden State Warriors won 42-22.

Neal

leswell profile image
leswell

Thrilled at the prospect and somewhat amazed although I really shouldn’t be. We will hope and pray with you—and for us since we are among your devoted students. This is the most hopeful news for me right now and for Leswell in the morning. Even though it’s not writ in stone yet, I’m so excited by the possibility that I just might wake him up. Don’t worry. I won’t. How on earth did I stumble upon this. (I’ve been listening to George Guidall read “Crime and Punishment” downloaded from our library which I last read at Hamline U when I was a freshman.) Keep on believing. Happy New Year. Let us all know when you take flight. Mrs. S

Neal-Snyder profile image
Neal-Snyder

I don't pray but I strongly share your hopes, Nal. Good for you!!!!!!!!

Any advice on precisely how to take the lipsomal C? Thanks.

Neal

Roland632017 profile image
Roland632017 in reply to Neal-Snyder

Hi Neal

It is 8:05 am in Sydney Australia.

I share with you as I don't pray.

This is also for Patrick who I have great respect for.

I like to share this story.

Going back January 17 I was weigh down by a certain thought and had been fighting with close family members. I think an injustice and injury to my pride has occurred.

I know if you are Deaf & Blind you will be excused.

So in January 17 I withdrew $10000 from my pension fund and gave to my mum. She then followed my advice and graciously donated $4000 to the Council of Deaf & Blind.

By this simple good gesture from me I think I have been rewarded with my recent quality of living and may even exceed outcomes than I can't even have imagined.

Now believe it or not.

Apart from my 2 Cystoscopy operations I am practically pain free and fatigue free other than slight tiredness during the day from frequent urination at night where by I did not sleep well.

OK over the last few days I had weakness/flu like symptoms and tenderness/pain in my spine where the bone metastasis is located.

OK this is bad sign but only when the cancer overwhelms you and cause you to suffer.

But this time I have escalated my treatment to try to snuff the beast.

I have recovered from my weakness/flu like

Roland632017 profile image
Roland632017 in reply to Roland632017

Sorry...... flu like symptoms over the 2 days. Now 3.5 days later my spine pain is also slowly disappearing.

I have said time and time again by letting my body do the talking.

Here is the question, What do you make of this recent experience of mine?

Happy New Year to you all.

Neal-Snyder profile image
Neal-Snyder in reply to Roland632017

Hi Roland,

I'm concerned that you have a bone metastasis & spine pain, even if maybe it's only if you have the flu. In all the years I've had bone mets, I've never had any pain associated with them. I assume that is because I've been accepting treatment, first from a urologist & then from an oncologist. I've supported that with complementary medicine. I have massage every other week to stimulate my immune system, & acupuncture in the weeks in between. The acupuncturist is also ah herbalist, & she carefully prescribes Chinese herbal prescriptions for me. She revises them as my conditions change. I got a highly recommended massage therapist & acupuncturist/herbalist. I have become extremely fond of both of them, & they of me, so it's especially pleasurable.

I am not qualified to assess your recent experience. I can tell you for a certainty that I think it is a life-threatening mistake to try to self-treat metastatic prostate cancer.

PLEASE accept medical help at this time. If you didn't like the specialist you saw before, see a different one. It's important to feel reasonably comfortable with your doctors. I actually like to ask them if we could be on a first-name basis. All of them have said yes, & we have friendly relationships.

Neal

Roland632017 profile image
Roland632017 in reply to Neal-Snyder

Hi Neal

Thanks for your prompt reply.

It sounds funny in your conversation with your Medical Practisetioners. I remember someone in the forum wants to address the Doctor by first name and was criticised.

The Doctor in question quoted " I don't want to waste all the money I spent on medical training as well as years of hard training for you to address me by my first name" Isn't this Funny.

So I am going to be rude.

The money that I generously donated to the Council for Deaf & Blind and my close golfer friend calling me Doctor/Professor I am inclined to award myself this Honorary Doctorate if I am able to cure myself.

Then anyone who is going to consult with me regarding Prostate Cancer cure will have to address me accordingly.

I am going to be s crusade and bidding them to donate to this site and donate to the Deaf & Blind.

Sorry no offence intended.

May you and family enjoy this Happy New Year.

Roland

Neal-Snyder profile image
Neal-Snyder

I got confused. It's the Solgar Sublingual B12 I've had a question about. I think you recommended that, too--am I right? I've been taking it right when I finish breakfast, between my lower gum & cheek, as directed. I wiggle my cheek some to speed up dissolving. Then I swish water around in my mouth to loosen it up, & wash it down with water before I brush my teeth. I assume I'm not expected to wait around for it to absorb in my gum & cheek before I move on with my day by brushing my teeth. So that's the 1 where I wondered if you think I have to do it differently.

I would not be here today without my own very self-sustaining way of life that I built up on my own. (I'm culturally Jewish, & just went to my oldest grandson's Bar Mitzvah, but since my parents didn't introduce me to religion until I was 6 or 7, I was already too rational to find that believing in God made sense to me.)

I've been extremely optimistic all my life. I have a very powerful set of ethics. I am confident, & comfortable with my decisions. Music is extremely important & soothing in my life. There are many other things I enjoy. My wife & I enjoy many things together, including 2 1/2 months in Southeast Asia in winter. My children, their spouses & my 4 grandsons all have a wonderful time every time we get together, which is frequent, since we all live within 20 minutes of each other. I have close relationships with friends. All of this makes me self-sustaining, psychologically strong & happy.

Of course I have no problem with other people finding different ways to sustain themselves & prolong their lives, including the power of prayer. I am very glad that it is keeping you alive!

Happy New Year!

Neal

Neal-Snyder profile image
Neal-Snyder

The stuff I bought is CALLED sublingual B-12, & I know what sublingual means, so I was surprised by the directions. I've had at least 1 other sublingual med & that didn't bother me. Having to dissolve a pill between your cheek & your gums is not as user friendly. But I guess my more general question is when do you decide you can move ahead & wash it down your throat & brush your teeth? As soon as it's dissolved, or after you've waited for some time after it's dissolved?

Shalom!

JLS1 profile image
JLS1

I was giving sublingual B12 to my husband (I take it daily) until the oncologist team at U of C said to stop taking. However that may have been because he was starting chemo. I became concerned about interactions between the supplements and his treatment, so I've just been giving him what they approved:

Calcium 600 w/ Vit D3400iu and

Mega EFA (1200 OMega-3 EPA & DHA via 2 pills/day)

Now I'm wondering if I should have put him back on the B12 and other supplements, mainly antioxidants (ie - astaxanthin) after he finished chemo?

Nalakrats, may I ask, do you have a list of supplements you've been taking that would be easy for you to post? TIA

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