Це відео не доступне.
Перепрошуємо.
New FDA Approval: Darolutamide for Hormone-Sensitive Disease | Mark Scholz, MD | PCRI
Вставка
- Опубліковано 15 сер 2024
- In 2019, Nubeqa (darolutamide) became the fourth 2nd generation anti-androgen to be FDA approved. There were hints that this medication could have less instances of fatigue when compared to other 2nd generation anti-androgens like Zytiga. However, at the time it was only approved for men in the very specific situation of having prostate cancer that was resistant to standard hormone therapy but non-metastatic. On August 5, 2022, the FDA extended its approval for darolutamide for men with hormone-sensitive metastatic disease. This news coincides well with other studies that are beginning to show greater efficacy with these medications when used as early as possible in the advanced disease course, for example, when metastases are present and before developing hormone resistance, and while it may have been possible for men in this situation to access Zytiga, darolutamide should now be an accessible option for men who are experiencing severe side effects and want to try a different medication.
0:09 What is 'hormone-sensitive' prostate cancer?
1:11 What is darolutamide?
2:24 Can you clarify the difference between standard or first-generation hormone therapy and 2nd generation hormone therapies?
3:06 What are the side effects of darolutamide?
4:19 Do the same strategies to mitigate side effects of standard hormone therapy apply to darolutamide and other 2nd generation hormone therapies?
7:26 If someone is on Zytiga or Erleada and they want to try darolutamide, should they talk to their doctor about it?
7:54 Is PSA decline a good metric for knowing of darolutamide is working?
8:48 How long should a patient wait to see if there is an acceptable PSA decline before moving on to different therapies?
9:05 Can you do intermittent hormone therapy with a drug like darolutamide?
10:09 How long does it take testosterone to recover after darolutamide?
Don’t know your stage? Take the quiz: Visit www.prostatecan...
To learn more about prostate cancer visit www.pcri.org
Sign up for our newsletter here to receive the latest updates on prostate cancer and the PCRI: pcri.org/join
Who we are:
The Prostate Cancer Research Institute (PCRI) is a 501(c)(3) not-for-profit organization that is dedicated to helping you research your treatment options. We understand that you have many questions, and we can help you find the answers that are specific to your case. All of our resources are designed by a multidisciplinary team of advocates and expert physicians, for patients. We believe that by educating yourself about the disease, you will have more productive interactions with your medical professionals and receive better individualized care. Feel free to explore our website at pcri.org or contact our free helpline with any questions that you have at pcri.org/helpline. Our Federal Tax ID # is 95-4617875 and qualifies for maximum charitable gift deductions by individual donors.
The information on the Prostate Cancer Research Institute's UA-cam channel is provided with the understanding that the Institute is not engaged in rendering medical advice or recommendation. The information provided in these videos should not replace consultations with qualified health care professionals to meet your individual medical needs.
#ProstateCancer #MarkScholzMD #PCRI
You guy are AWESOME!!! Thank You for posting all this wonderful information ove the years. God I wish I would have found your site a couple years ago before I had my prostatectomy. The ED is the major issue but mainly have the urinary leakage issue under control with the kegel exercises. Again Tank You for putting all this information out for men to see and learn from.
Another great video. You are making a HUGE difference in knowledge and hope..
Thank you all so much for the information. I can understand better about my husband's condition!
Great informative thank you
Very informative. Thx so much
This is very good news for future patients of Prostate Cancer! Lupron just as Eligard (known to be the same) injections has literally ruined my life
ALL OF THESE TREATMENTS ARE HORROR SHOWS. FDA AND YOUR DOCTOR TAKE BRIBES
Great video. Thank you.
Very informative Thanks
excellent content
I am not on any ADT but given the recovery from ADT is "almost immediate" in 2nd generation drugs, why aren't these used as single agents immediately since that is a major benefit first generation ones don't have? is this simply a function of expense? or is it because when Lupron becomes ineffective, these drugs can be substituted and thus add to the survival period?
FDA AND YOUR DOCTOR TAKE BRIBES
Thanks
Does this medicine work after Xtandi stops working? Or are both of these meds the same, so no reason to try if Xtandi stopped working?
Kym (74) in Darwin Australia. I have non-metastatic prostate cancer and had radiation therapy last year. Together with 3-month Eligard jabs, my PSA fell to just under 2 by January. After rising to 12 by May, my oncologist has scheduled Darolutamide too, from July. Question: I have had moderate gynocomastia (breasts) since puberty. Does it increase the risk of prostate cancer ? My late dad died at 77, of leukaemia but also had prostate cancer. His leukaemia may have resulted from his occupation-force service in Japan in late 1945, including a visit to Hiroshima. (He said his intestines were never the same, afterward).
So casodex/bicalutimide is a low dose version? Why wouldnt someone be prescribed this while taking a first gen?
EXACTLY. IT IS ALL TO DO WITH BRIBES
I appreciate your videos but I dont like the assumption that not catching cancers early is the patient's neglect. My husband was doing PSA testing every year and complaining about back pain for a few years, yet by the time the doctor found the cancer he was stage 4. His mother died of breast cancer and it turns out he is brca2. (this was in the med history) Its not always on the patients, sometimes the fault lies in the doctors. I've heard of many cases like this in FB groups that I've joined since the diagnosis.
Does it make sense to try darolutamide once Zytiga has stopped working? My oncologist wants me to try it instead of chemo while I am on the waitlist of Lutetium.
YOU ARE IN DEATHROW.
ADT IS A HORROR MOVIE.
IF YOU ARE OVER 75....SHUN IT
It's nice that the FDA has approved this med, but does anyone realize that insurance and Medicare coverage is minimal and not until there is a generic form most patients will not be able to afford it?
Medicare coverage varies by state/region because it is administered by different organizations, so I am not sure about the details, but there could be situations--for example, if the cheaper generic abiraterone is causing intolerable side effects--in which a physician could say that the generic option is not working well, prescribe a medication like darolutamide, and have it covered since the cheaper option was not working.
The manufacturer, Bayer, also has financial aid services. I am not sure if it would be helpful for you, but they have a website with a customer service phone number, and they have employees with whom you can speak, explain your situation, and see if you qualify for anything. You can find that here: www.nubeqa-us.com/patient-assistance-support
If you have anymore questions, feel free to contact our helpline at pcri.org/helpline.
REMEMBER... FDA AND YOUR DOCTOR TAKE BRIBES
Does the most recent darolutamide approval apply to a patient, like me, who is newly diagnosed with 4+3=7 gleason where pre treatment psma pet scan states: "Subcentimeter tracer avid lymph nodes in the pelvis as detailed above,
highly suspicious for nodal metastases." Does medicare cover this as part of an initial treatment with lupron and radiation?
UPDATE - I was offered the opportunity to participate in a darolutamide trial and I am now taking lupron and darolutamide together in combination for six months and with a 9 week course of beam radiation. The trial is designed to assess whether use of darolutamide combined with Lupron as part of initial treatment will reduce instances of spread after initial treatment.
I was on it...3 months later a pmsa pet showed a reoccurring cancer. A new biopsy is scheduled. Maybe immunotherapy or pmsa lu177
Mike how your appoinment went well and I am sorry that you are going through this. I was thinking about checking into my father go on this. He just found out he has metastasized Prostate cancer that may have spread to his bone. We are just trying to figure out the best one for him to go on ASAP. He went in for something not even prostate related, and decided to have it check because he was due and his PSA was 78! He had no symptoms.
From what is said in this episode, is it true that those folks in the castrate sensitive, low volume space with maybe a few pelvic metastases may still take a holiday from anti-androgen therapy every so often? what is in the literature about who should and who shouldn't take drug holidays from androgen suppressing medication? Does everyone with metastasis become ineligible to take further drug holidays? If not, from what we know now, which group of men have worse outcomes when taking holidays from androgen suppressing drugs? Thanks in advance for your response!.
I think if you check thru their videos these issues are dealt with there
ADT IS A HORROR MOVIE.
IF YOU ARE OVER 75 TRY ALTERNATE CURES
How do you feel while on this drug ?
I personally have felt weak in the legs and leg pain like after working out …muscle soreness
Zytiga stopped working along with xtandi, referred to chemo by oncologist. Would this have been a better option for me???
There are rare cases in which trying a different 2nd generation anti-androgen like darolutamide will work as an anti-cancer maneuver, at least to some degree, when other similar medications like Zytiga or Xtandi fail, but it is rare and it is usually only attempted, at least by itself, when all of the other options have been exhausted or perhaps in an obvious palliative situation, for example, in a frail elderly patient with a lot of co-morbidities whose quality of life might be put at risk by treatments with totally different mechanisms of actions like chemotherapy, radioligand therapy, immunotherapy, and/or targeted therapies (if the person has one of a few genetic mutations that make those an option).
There have actually been studies published recently from phase III clinical trials (the type of trial producing the strongest evidence) demonstrating that there is greater anti-cancer benefit over time from using therapies like chemotherapy earlier in the advanced disease course, rather than waiting for hormone therapy to fail. I am not sure if this would apply to your case or where other possible treatments could fit in, but if you have any questions, you are welcome to contact our free helpline at pcri.org/helpline. We have patient advocates who can provide you with information and help you form questions for your doctor to ensure you are getting the best possible outcomes based on your unique situation and desires.
অওঅঅঅঅঅঅঅ
If you have prostate cancer, there is no good options unless you just have a great desire to live an iffy life as half a man always looking over your shoulder for the next wave. Maybe just live 100% until you die. Of coarse big pharma won't be happy with you ??😂
ADT leaves up to twenty percent of older men with permanent CASTRATION, as their testosterone levels will NEVER RECOVER ABOVE CASTRATE LEVEL. So, why don't doctors warn patients about this risk that they will suffer the horrific and often life threatening side effects until they die???
...Could it be because they are more interested in selling these outrageously expensive drugs than any concern for quality of life.
Is darolutamide approved for use, as a second AR, without docetaxel, for men with metastatic hormone sensitive prostate cancer? i.e., can l add darolutamide, as a second agent, to my current degarelix(Firmagon)? Must darolutamide always be used with chemo? I want to add darolutamide to my degarelix without docetaxel (chemo). Does that sound do-able under current practice?