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New medication, Apalutamide (a handrogen receptor inhibitor)

mtop
Posts: 18
Joined: Jan 2017

Is anyone currently on Apalutamide? My doctor wants me to start on this new durg and I'm not sure about it.

Brief history: 66 years old, with Gleason Grade 4+5=9. Had Radical Prostatectomy in 2016 and radiation treatments for seven weeks starting 5/17. The cancer is Non-metastatic and am currently on hormone treatments (Lupron) 2+ years. All of my PSA tests since being on Lupron have been undetectable around 0.014.

From what I have read Apalutamide is designed for non-metastatic cancer that is castration resistant. As of now mine seems to be kept as bay buy the Lupron. (For how much longer is not known.) I just don't want to take this new drug to early, plus it has many of the same side effects as the Lupron and I really do not want to add to them or make the ones I have now worse. 

So my question is anyone out there in the same boat as me or that my have any insight ON the newly approved drug.

Thanks.

Old Salt
Posts: 720
Joined: Aug 2014

Yes, you are right, apalutamide is used after Lupron fails.

Why don't you ask your doctor for his reasoning?

mtop
Posts: 18
Joined: Jan 2017

Going to next appointment.

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
Posts: 3255
Joined: May 2012

Chemocare.com data regarding Alpalutamide.  To open the article, first HIGHLIGHT it, then RIGHT CLICK, and then press "Go to...."

max

 

http://www.chemocare.com/chemotherapy/drug-info/apalutamide.aspx

G53
Posts: 33
Joined: Jul 2018

Apalutamide is named Erleada and approved since the 16th of Feb this year.

https://www.erleada.com/

I personally do not think you need to combine ADT with this. However, the trial which led to the approval added ADT to make sure the control group would get the standard of care. So now everyone has to take ADT with Apalutamide.

G53

VascodaGama's picture
VascodaGama
Posts: 2968
Joined: Nov 2010

MTOP,

I wonder if the PSA at 0.014 ng/ml signifies that you are "cured". You should try checking it firstly before starting any newer therapy.

From your entries in other threads, you have said that you've been on Lupron continuously since September 2016 and did RT May 2017. Lupron is palliative but the radiation treatment could have killed the bandit if this still existed after RP, which is now represented by the very low levels of PSA.
I do not know details of your initial diagnosis (apart from the Gleason score 9 described by you) or the treatment protocol but I imagine that the choice in surgery back in 2016 have been done based on the clinical stage (with references to image studies) that judged you with a contained case. Surely, the aggressive Gleason 9 may have influenced the choice in the initial protocol that could have been a combo of neoadjuvant surgery followed by adjuvant ADT+RT. I wonder if your doctor has ever discussed on such a possibility of cure after two years of treatment.

Apalutamide is an antiandrogen that complements Lupron. It does not substitute it in the hormonal manipulation process. Apalutamide is similar to the expensive Enzalutamide (Xtandi) used for many years in castration resistant cases (refractory). These sort of antiandrogens are more refined than the popular ones (Casodex, etc), which apart from providing protection against traditional androgens (testosterone, etc) they manage to avoid absorption of the refined dihydrotestosterone (a tenfold more potent androgen) which is seen as the cause for initial treatment refractory.

Typically antiandrogens are added to agonists (Lupron, etc) to provide added blockades in the ADT therapy. Some famous oncologists still add a third blockade with a 5-ARI drug (finasteride, dutasteride, etc) exactly to avoid the refinement of testosterone into the powerful dihydrotestosterone. They call this ADT3 (3 blockades or total blockade) and use it in very aggressive cases.

Apalutamide is now on clinical trials. Your doctor may be thinking in your possibility in participating in the trial. This is good but it may require you to give up with Lupron due to trial restrictions (?). The drug will also affect your existing bone problems (you commented in another thread), probably prohibiting also the use of Prolia suggested to be added to the therapy by your doctor.

I am not a doctor to advice you and do not know your real present status but I believe that you need a drugs free period to give you time to recuperate from the side effects of such a long treatment (24 months). In fact, you are not experiencing refractory yet and the trial will be there for several years giving you the possibility in postponing it for a more convenient occasion. I recommend you to discuss the matter seriously with your doctor.

Best wishes for full recovery and continuing remission.

VGama

mtop
Posts: 18
Joined: Jan 2017

Thanks for all the info. I will be researching  and discussing what I've learned with my doctor. Being classified as G-9 High Risk, being cured was not something that I thought of, nor was it ever brought up as a possibility by my doctor. Something else to talk about for sure.

Thanks again.

G53
Posts: 33
Joined: Jul 2018

Apalutamide is for castration resistant patients. You are still hormone sensitive. Currently you have "no detectable disease".

If I were you I would switch to intermittent ADT. Observe the PSA value till it gets over 10 ng/ml and restart ADT. Repeat as necessary. Once you are resistent you can still start with Apalutamide.

G53

mtop
Posts: 18
Joined: Jan 2017

G53,

I get what you and VGama are saying about getting some time off from the ADT. I would love to have more engery, some memory back, and everything else. My problem is that I'm not as knowledgeable about this diseaseas I should probably be. Or at least as infromed as some of you all seem to be. Anyway my problem is that I am quite concerned about stopping the ADT shots as I contribute it to my low PSA tests and am afraid the the cancer will come back with a vengeance and the Lupro will not be as effective anymore. I know that I can't be on it forever and I do hate the side effects but its working for now and thats all I know. I am going to speak with my doctor next week about holding off on the Apalutamide. I will as my doctor for his opinion on halting the ADT for a while. We had a conversation early on about stopping and restarting the ADT he wasn't a real fan of the idea.

Mtop

G53
Posts: 33
Joined: Jul 2018

Mtop,

since you had surgery and radiation, I think your doctor should not put you on lifelong ADT now. Even if you become resistant, they will just add new drugs and continue with ADT.

The guidelines do not require that salvage radiation is done in combination with ADT. So I think you had your share of ADT for now.

Please be aware, if you stop ADT now, Testosterone will take up to two years to fully recover. The side effects will remain during that time.

G53

mtop
Posts: 18
Joined: Jan 2017

Non-metastatic prostate cancer remained within the prostate. Metastatic cancer was also found outside the prostate. At time of surgery 16 lymph nodes were removed one was found to contain cancer. Doctor classified my cancer as non- metastatic???????

Old Salt
Posts: 720
Joined: Aug 2014

I agree that this is a bit confusing, but the oncologists define metastasis for when the cancer has spread to 'far away' places. See

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/metastasis

mtop
Posts: 18
Joined: Jan 2017

Thanks Old Salt for the information and link to the website. Yourself as well as others on these discussion boards seem to be very knowledgeable on the subject of prostate cancer. If I may ask where do you obtain most of your information? I would like to do some research of my own but have no idea where to start. Thanks  again.

G53
Posts: 33
Joined: Jul 2018

Mtop,

here are some links providing information for PCa patients:
http://www.ustoo.org/Read-Educational-Materials
https://www.cancer.org/cancer/prostate-cancer.html
https://www.nccn.org/patients/guidelines/prostate/index.html#

If you read all this, you will have gained a lot of knowledge.

G53

mtop
Posts: 18
Joined: Jan 2017

Thanks G53, I will check them out.

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
Posts: 3255
Joined: May 2012

mtop,

I recommend as a beginning foundation a best-selling book by the former head of Surgery at Sloan Kettering CC in NYC:  Dr. Peter Scardino's Prostate Book.  Dr Scardino is still a surgeon at SKCC, but no longer Director.

The value of this work is that it covers everything in PCa. An overview of the gland and all forms of prostate disease (BPH, prostatitus, cancer, etc), Cell types, modes of spread, the diagnostic process (including a history of PSA and the differnt types of PSA testing), and then compares all treatment types.  Radiation (all forms), Surgery, and HT each has its own chapter.  Then, a chapter on second-line therapies (therapies required after relapse).

It is inexpensive, and is a regular-stock item at Barnes and Noble and Amazon.  Fairly simply written, it is a great base for later moving in to more advanced sources, like Oncology Journals.

Most of the guys here learned what they know through experience. Plus they are smarter than most. Most men never consult a source like this, since most people go with whatever their local urologist tells them, and never question anything.  How do I know this?  Around 165,000 new cases of PCa every year, just in the US.  Nearly 29,000 PCa deaths every year, just in the US.  But there are maybe 20 ("twenty") regular contributors here.   165,000 divided by 20 is one in 8,250 cases significantly using this site.  But, in any given year, there are several  million men in the US with some degree of PCa, so the number would be perhaps closer to one in 10,000 visiting here.  Of course this is an approximation and not a professionally derived number, but you get the idea:  The percentage of men consulting here is microscopic, whatever the number.  And I do realize that many men use the site to their advange just by reading, and never joining or writing anything.

Our learning is "blue collar," if you will: Learn by doing.  I followed two friends to their deaths against PCa, and was one of these men's liasion with his oncologists, since he was alone and not very attentive.  Then I got my own case of PCa, after having spent a few years dealing with highly advanced lymphoma. I mostly write at the Lymphoma Board, but try to stay current hhere also.  Having been run over by a car decades earlier and spending two years in rehab also taught me lots of 'medical verbage.'   

I say to people "I've had no medical training; I've just had ever medical thing.  Many of the guys here are similiar, with unbelievable stories. 

You asked how some of the guys here got to where they are, and that is how.

max

Old Salt
Posts: 720
Joined: Aug 2014

I admit that I barely knew what a prostate was or what it does prior to my diagnosis. So there is hope for us all. I decided to find out more after my diagnosis and became involved in the management of my disease. It took a lot of reading and time. I also read two other prostate cancer forums on a regular basis. One of them is particularly helpful in the sense that it provides fairly solid medical advice (based on clinical studies, medical papers etc).

It also helps if you have medical professionals who will work with you. Mine did, which was great.

PS: Others have given solid advice in the meantime (see above).

mtop
Posts: 18
Joined: Jan 2017

Had appointment with doctor this morning and discussed new drug, current ADT and intermittent ADT. PAS test done last week in prep for appointment was 0.014 (lowest number that their device can measure to.) Also had testosterone tested it was 13. Doctor reminded me that after the RP that my PSA still went up as it also did after RT. That is why I went on ADT. Since on ADT PSA has been very low. Because I am classified as high risk and that during surgury 16 nodes were taken with on testing possitive he can't be 100% sure that RP and RT got all of the disease. Doctor, wife and I dicusses going off ADT, intermittent ADT, and staying on ADT for now.Wife and I are not quite ready to take a chance on cancer comming back nor to see if it would go fron non-metastatic to metasstatic. So for now I'll be staying on the Lupron. We talked about taking Apalutamide and it was agreed that it would be started only after the cancer becomes castration resistant. Going off of ADT or intermittent ADT can / will be discussed during future appointments. In the mean time I will be doing more research on Pc with the info you all have provided me. Thanks again.

mtop. 

Old Salt
Posts: 720
Joined: Aug 2014

You discussed all options with the MD and came to a rational conclusion on how to proceed. Excellent!

Glad to see that our thinking about keeping apalutamide 'in the bag' for when necessary in the future was accepted.

Best wishes for keeping the cancer under control, or wiping it out altogether.

VascodaGama's picture
VascodaGama
Posts: 2968
Joined: Nov 2010

If I read it correctly, your doctor has diagnosed you with metastatic disease for the failed RP in 2016 (verified through an increase of the PSA = no remission seen) which interpretation was certified by the finding of lymph nodes involvement (1 out of 16). Then you were moved to the sequential combo of ADT + RT which is ongoing.
I believe that the PSA has dropped since your starting ADT in September 2016 and it has reached 0.014 ng/ml as of today. One doesn't know if the RT of May 2017 has been successful in eliminating the cancer. Such is to be checked once you end the ongoing treatment (decided by your doctor) and the effect of ADT ends.

I think you are doing well in following your doctor's recommendation, waiting for the end of the established protocol and add newer treatments/drugs (similar to Apalutamide) once or if refractory is verified. The testosterone level at 13 ng/dL means that Lupron is doing its job well. Chemical castration is for T= <1 to 25. Refractory is seen when T is low but the PSA increases continuously. This is the timing when you should be substituting Lupron with newer drugs or add something.

Thought, ADT manages to hold the bandit from advancing, this is not a walk in the park. Apart from the common menaupose symptoms it affects body function leading some organs to failure. The kidneys, liver, bone and cardio are the most affected. Deterioration is common to occur after a period of over 24 month on agonists (chemical castration, etc). Some guys do not recover well and some never return to normal levels of T. Many doctors believe that continuous ADT provide longer periods free of chemical failure (longer term in low active cancer-low PSA), but the body is suffering and in failure, if not by the cancer by loosing due functionality. Other illnesses start to rise and in need of care. This is where proper intermittent approaches win.

I had failed RP in 2000, did RT in 2006 and started ADT in 2010. The protocol involved intermittent ADT which is regulated by on/off switches using the level of PSA and a fixed period in hormonal drugs. I started ADT at a PSA of 1.0 ng/ml and was kept in remission (lower than 0.05 ng/ml) with three continuous Eligard 6 month shots (same as Lupron) that assured one year on continuous remission. T come down from 290 to <1 ng/dL and it started to increase approximately at the 24th month (4 month post loss of Eligard effectiveness). The PSA accompanied the increase of T going from a low <0.02 ng/ml to the present 1.64 after 5 years on ADT vacation (free of drugs and free from side effects). I expect to restart ADT when the PSA reaches the trigger threshold of 2.0 ng/ml.
We got similar occurrences but have different cases. I was diagnosed a G6 with micrometastases not as aggressive as your case.

Please note that once the prime tumour (non-metastatic) is dissected in RP, what rests is metastatic cancer. This is what you have attacked with RT weaponry. I hope you have successfully killed the bandit and tell us about your continuous remission.

Best wishes in your continuing journey.

VGama

mtop
Posts: 18
Joined: Jan 2017

Thanks for the information and support. Still a little confused about being non-metastatic or metastatic. Doctor still talks (non) hence the thought of going on Apalutamide at a later date. Will talk with doctor at next appointment in December. Right now concentrating on up coming rotator cuff surgery on the 27th. Three tears right shoulder,my primary arm. Isn't it just one thing after another!

mtop

G53
Posts: 33
Joined: Jul 2018

VGama wrote: "I expect to restart ADT when the PSA reaches the trigger threshold of 2.0 ng/ml."

I think to restart at a PSA of 2.0 ng/ml is way too low. See the trial:
"Locally Advanced and Metastatic Prostate Cancer Treated with Intermittent Androgen Monotherapy or Maximal Androgen Blockade: Results from a randomised Phase 3 Study by the South European Uroncological Group"
https://www.europeanurology.com/article/S0302-2838(13)00342-4/fulltext
(cut and paste) and
https://www.urotoday.com/conference-highlights/aua-2018/aua-2018-prostat...

In this trial they restarted ADT when the PSA value got above 20 ng/ml! As far as I recall the trial included patients with a higher risk than you. But I think you could still wait till your PSA value reaches 20 ng/ml. The only reason could be that you may never reach a PSA value that high during your remaining lifetime. So you will get a very long ADT holiday.

G53

VascodaGama's picture
VascodaGama
Posts: 2968
Joined: Nov 2010

MTOP,

Some doctors use the term "non-metastatic" in extraprostatic extensions cases of localized cancer. They use this to distinguish from far metastases at areas where cancer has set in organs (lungs, liver, etc) and bone (ribs, etc). I believe that he is telling you that the cancer is localized (at surrounding tissues where the gland used to lay). However, the close lymph nodes expands beyond this area which may be seen differently by other experts. Treatments for localized cases have more assurances of success than cases with far metastases (not you case).

G53,

The trigger switches in intermittent ADT (IADT) approaches varies by the initial conditions of the patient and histology of PSA. Aggressive and high risks cases also do intermittent ADT but they use substituting drugs while on ADT vacation. Their approach tend to have shorter terms on vacations (reaching faster the trigger threshold) which leads to use higher PSA levels for allowing the benefit of being in intermitent instead of continuous.

My case has been established by my doctor according to the period in remission and time taken from nadir to recurrence after RT. My case follows the practice of famous medical oncologists specialists in treating advanced cases of PCa such as Dr Myers. In my case remmission was one year in PSA levels lower than 0.05 ng/ml but Myers prefer at least one year on PSA= 0.01 ng/ml. I also use monotherapy with an agonist alone (if enough). The majority of aggressive cases use 3 blockades with antiandrogen plus agonist plus 5=ARI, therefore an increase in side effects that lead to faster deterioration of other functions. These guys are the ones that benefit the most from IADT.

Best wishes,

VG

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