Darolutamide and mCRPC...New Promising Drug

[gusgold]

Darolutamide can work even when resistance to Xtandi and Zytiga has developed

Gus

tandfonline.com/doi/full/10...

[Hidden]

I'm hoping that I am still around when this is approved for use as a second-line ADT treatment for CRPC. Could be another 3 or 4 years, hopefully sooner. Darolutamide is showing a lot of promise to be an improvement over the drugs currently in use.

[Nicnatno in reply to Hidden]

Hey Gregg, let's not think about mortality rate. With PCa, we will still be around way past 3-4 years. I'm just thinking more about Irma and our citizens in Florida. I said to myself that I will not dwell on this disease. I will always comply to all my doctors, including my dentist for better health.

Nick

[Sisira]

Hope all the Trials will be competed properly and the Drug be pushed from the bench to the bedside soon.

Thank you gus.

Sisira

[wifeofvet]

i don't know where you live but if you live in one of the states that has enacted the ''right to try'' law,

righttotry.org/faq/

you may be in luck.

my husband's doctor contacted Bayer without knowledge of this law and begged for compassionate use and was denied because they have no compassionate use program because no one (or not enough people) have requested the drug. we are reapplying under the ''right to try'' law in hopes they will reconsider. i THINK it's may be mandatory in those states that they comply. there is a link inside from the goldwater foundation which will guide you to a form letter that you should use while applying to Bayer. this is the address we used the first time:

Bayer Corporation

100 Bayer Boulevard

Whippany, NJ 07981

USA

Phone: [phone]

i posted a request for anyone on this site who needs it now to call them, last week, in hopes of creating a compassionate use program. instead, i got a half dozen analyses of the drug from the folks who replied. i would beg that you do it. these drugs become fast-tracked when we beg en masse...if nothing else.

on the positive side, if we need it now, we could/might force their hands to supply us until it is approved.

if you know anyone else who is at the point of failing Xtandi, please urge them to do it, also.

THANKS.

[BigRich]

Gus, Thank you for the article. It was a good read.

Rich

[leswell]

Gus, Agree with BigRich. I will bring up Darolutamide trials for mCRPC patients with Dr. Tareen tomorrow. Mrs. S

[Dan59 in reply to leswell]

Thank You, I am interested to hear about darolutamide, and proxalutamide.

Dan

[leswell in reply to Dan59]

Will do. Much ground to cover in a first appointment. Four typed pages thus far which the urologist/surgeon can read at his leisure.

My patient is nervous about any changes in the med regimen as am I. Some new combination has got to bring down that 166 PSA. Also, we should know within a week what his liver enzyme levels are in order to know if we need to eliminate the bicalutamide. Btw, he’s taking no more pain meds following surgery on the 3rd. The stitches look huge and most secure on that inguinal hernia repair. Les is feisty and on the mend. Thanks for the prayers and support of those who “know” us. Jan

[Dan59 in reply to leswell]

Jan, Has he been on bicalutamide with a rising psa, just saying because sometimes bicalutamide can add to the cancer and a response can be seen by stopping it. Glad to hear Les is on the mend, and feeling fiesty. My current psa is 123 after 4 jevtana. I go for scans in the morning and meet with Oncologist weds for chemo if blood numbers are good. I tried to find what treatments Les has done , but could not. What treatments has he done so far?

Dan

[leswell in reply to Dan59]

Hello again, Dan,

Les had no testing done at all for seven months. I think he sort of fell in the cracks between doctors, but all is straightened out now. In April we found out about the much higher PSA, and I did decide to eliminate the bicalutamide in the hope that doing so might cause a reversal. In a couple days, I had second thoughts about playing doctor and had him keep taking it until now in order to be consistent. Trust we havn’t caused irreversible liver damage! It will be a relief to be seeing two doctors after seeing none, i.e. urologist/surgeon tomorrow and oncologist and blood draws on Tuesday.

Best wishes to you for those scans tomorrow. 4 Jevtanas done. Bravo. I wish we could say the same but, you know, we’re both 80 in 2019. We’ll just consider the new phase another marathon. Go well. Les and Jan

And now for a P.S. longer than my reply. During the past two years, Les’s treatment has been as follows. Dan, you are the marathoner in this case. What is it, 12 years now? Truly amazing. Okay, here goes. Feel free, anyone, to make corrections or offer suggestions.

“To Dr. X,

Thank you for agreeing to assist us during the second phase of Les’s Stage Four prostate cancer. We are grateful to your colleague, Dr Y, for his recommendation and to Dr. Z who has been our MO during Les’s early combined chemotherapy and hormonal therapy. Dr. Y indicated that you are most often the physician in this clinic who deals with more “advanced” patients, a category into which Les now, alas, fits.

It was Dr. Y who diagnosed Les as having Stage Four cancer on April 15, 2016. DRE and TRUS revealed a PSA of 1500 and GS of 7 + 9. (Does that mean Les’s score is the higher of the two? Never heard of a GS of 16!) He immediately had two abdominal injections of Firmagon which reduced the PSA to 906.65. A transfer to Dr. Z for chemotherapy resulted in six completed cycles of Granisetron HCl, Dexamethasone (reduced from 10 to 5 to 1 mg), Zoledronic acid, Docetaxel, and Pegfilgrastim. Scans at United Hospital revealed innumerable bone metastases and two cancerous lymph nodes in the groin. Scans taken following chemotherapy showed greatly reduced numbers of bone mets and no cancer in lymph nodes or other organs. Chemotherapy also resulted in huge, hard legs and a dx of bilateral lymphedema. After treatment and with continuing monthly Lupron injections, Les’s PSA reached a nadir of 2.82. It rose to 169.22 during a three month “vacation” but, once reinstituting leuprolide, did not return to <21.97. During the past seven months my husband has had no blood draws for PSAs or CBCs until a PSA taken this April in Dr.X’s office, the disappointing result of which was 166.72. Whether this was a spike or bounce we don’t know without having had more frequent testing.

For the past six months Les has been using a CAB-5, i.e. Vantas (installed October 23rd by Dr. A), bicalutamide (concerned about no liver enzyme tests while taking that), dutasteride, finasteride,and DIM. Additional supplements he is currently taking are as follows:

Metformin Hcl 500 Mg Tab (would like to increase slowly to 2000 Mg to prevent diabetes as a result of ADT)

Sublingual B12 (methylcobalamin) 1 5000 Mcg Tab.

PectaSol-C (modified citrus pectin), ecoNugenics, 5 gr 3x daily with liquid on an empty stomach

Vitamin D3 5000 IU (LEF)

Super K with advanced K2 complex (LEF)

Calcium Magnesium Complex

1000 Mg - 500 Mg, respectively, one tablet every other day (Country Life)

Extend release Magnesium (LEF) 250 Mg Cap every other day (just finishing this which we already had)

Turmeric Force 1 Cap (New Chapter)

Acetyl-L-Carnitine 500 Mg Cap (NOW)

Side effects experienced from the chemo/hormonal treatment have been hypogonadism (if nearly total chemical castration can be referred to as that), minor gynocomastia, sudden deterioration of vision and hearing, dementia (dx by Dr. B, neurologist), bilateral lymphedema (dx by Dr. C), loss of muscle and mobility, and increasing fatigue. Lots of napping going on at our house.

As an example of his deterioration, in 2017 Les cared for a 4400 sq ft garden. Anything approaching that right now looks unlikely since he has difficulty navigating from his chair or the bed to the bathroom which is partly due to a painful inguinal hernia (successful surgery performed May 3rd by Dr. D) plus increasing bone pain in his left hip and back. To date Les has not had cancer surgery or radiation—which makes the cause of lymphedema puzzling. The reason for not having radiation is our worry that it might advance his lymphedema plus the lack of access to Mayo’s proton beam machine since Les is not, we think, oligometastatic. Which brings to mind another question. Why, in light of his bone metastasis, wouldn’t Zometa have been continued following chemotherapy?

We both read recommended articles from Health Unlocked’s Advanced Prostate Cancer site, and I, Mrs. S, correspond with a number of fellow “victims” and caretakers who have been our primary source of information and consolation.”

This goes on, Dan, but it’s probably a good place to stop. I hope you and a number of others know how grateful we are for all you have written and rewritten at our our request. Unforgettable, that’s what you are.

[Dan59 in reply to leswell]

I do not see that he has done xtandi, Perhaps that would be a possibility for an oral med. I have found the jevtana to be more tolerable than docetaxol, though it is generally worse for white blood counts( I get nuelasta now). It will be 12 years in June, and I will be 62 on July 4th. I wish you both the best, and may God Bless you both!

Dan

[leswell in reply to Dan59]

I will remember what helped you and might extend our time together. Thanks as always. Jan