It was approved only for for patients who are metastatic and have been previously treated with androgen receptor (AR) pathway inhibition (e.g., Zytiga,Xtandi,or Erleada) and taxane-based chemotherapy. They also approved Ga68PSMA11 PET (Locametz) for identification of PSMA-avid patients (it was formerly approved for high risk and recurrent patients).
Novartis expects it will be widely distributed in weeks.
Following the successful results of the ARASENS study, how long do you think it will be before the FDA approves Darolutimide for castration sensitive men?
Are there any planned studies to compare: ADT + ARI vs ADT + Docetaxal + ARI?
ARASENS should have added a third group of men with Darolutimide + ADT but no docetaxal to see if docetaxel added significant amounts to OS, especially since many of the men starting on Darolutimide have already been on ADT for several years (not recently diagnosed with cancer).
T-A Are there any studies aimed at hormone sensitive patients. Any prognostications on when radioligands might be approved for oligometatastic patients?
Please explain what is ment by metastic? Does that mean bones only? Lymph nodes, where do they have to be, outside pelvic area? Organs?
Please explain more clearly what you mean by newly diagnosed, while still referring to having had chemo and AR. AR being resistant to androgen receptor directed 2nd line ADT ?
Please help me/us understand it. Is this correct?
Androgen naive - never had ADT
Androgen sensitive - aka hormone sensitive, ADT still effective
Hormone resistant. 1st line ADT not working, 2nd line ADT effective.
Castrate resistant All ADT not effective
Or are hormone resistant and castrate resistant the same?
On another question
What does it mean to be stage 4 as opposed to stage 3.
What and Where does your cancer have to be to be stage 4?
Does failing RP and whole pelvic salvage radiation make you stage 4?
Metastases are cancers outside the place of origin. For prostate cancer, that usually means lymph nodes (Called N1 if pelvic, called M1a if beyond the pelvic area) or bones (called M1b), and sometimes distant visceral organs like the liver or lungs (called M1c).
Newly diagnosed means treatment-naive. If you've had chemo or advanced hormone therapy, you are not newly diagnosed.
Castration resistant means that the cancer progresses in spite of ADT. "Hormone resistant" is not used.
Stage IV means the cancer is outside of the prostate, either in adjoining organs (T4) or metastasized.
Failing salvage therapy is designated as "recurrent"(stage R1) or "persistent." Stage IV is only designated if found on biopsy, CT or MRI.
Thanks if I can drill a little further if you don't mind.
So where you say advanced hormone therapy, your referring to 1st level such as Lupron and 2nd level such as Zytiga, meaning either level constitutes advanced hormone therapy?
You could have been n0m0 at RP, with with persistent PSA or recurrent rising PSA, but then of course become n1 and/or m1 later on by findings on a scan(s) etc. Either n1 (local) or m1 (distant) means your metastatic.
Are you saying that PSMA, AXUMIN, or Choline scans as they employ a CT scan as part of the PET scan, could also be used to determine existence of PC.
And rising PSA alone(( three consecutive blood tests at 3 month intervals) (either above 0.1 or below 0.1 )) after RP or whole pelvic Salvage Radiation cannot be used to classify as Stage4. Even if scans prior to RP or prior to Salvage radiation showed PC mets.
It must be located and confirmed by scan, MRI, or biopsy after Salvage Radiation.
That's a lot of drilling but think it really clarifies it.
"So where you say advanced hormone therapy, your referring to 1st level such as Lupron and 2nd level such as Zytiga, meaning either level constitutes advanced hormone therapy?" No. Lupron is ADT, not advanced hormone therapy.
"Are you saying that PSMA, AXUMIN, or Choline scans as they employ a CT scan as part of the PET scan, could also be used to determine existence of PC?"
PET scans are not currently used to formally determine N1 or M1 (according to AJCC), only CT, MRI or biopsy, as I wrote. But the formal AJCC stages are not used in practice. All oncologists use PET scans if they are available.
Anywhere in the US allow a HSPC patient to do the LU77 out of pocket? If so any idea what that might cost? What are your thoughts on efficacy for HSPC TA?
No idea what it would cost out of pocket. But it is available off-label now. I would guess it's useful and not too toxic as long as there are enough mets of sufficient PSMA-avidity.
Good news , thanks much for for the info, as always...have not read the clickable link yet, but in brief what is are Taxane based chemotherapy? Is that docetaxel,or something else?
Wings
BTW, I am still on Zytiga and still PSA undetectable, 7 years ,4 months now
Fantastic! My husband's PSA remains undetectable at five years this month. He's on Lupron only after a very early cycle of Docetaxel and a very short stint on Zytiga in early 2018.
Thanks for posting this, Allen. Another tool in the toolkit.Question: does the Lu-177 only target prostate cancer cells expressing PSMA? The reason I ask is that I erroneously thought the tumor in my bladder was bladder cancer. My oncologist told me today that it's prostate cancer that doesn't express PSMA.
Yes, Pluvicto only kills metastatic PCa that expresses PSMA. PCa that has eaten its way up to the bladder (Stage T4) is not metastatic and may be killed by a combination of targeted radiation and hormone therapy.
I cannot have a curative dose to my bladder as I had salvage radiation treatment in 2012.I learned yesterday that my cancer has progressed into my liver and lungs. I am being considered for yet another trial and if not then it’s the nasty chemo combo for me.
Good to hear. I'll remove the question of my doc whether I can get LU-177 before an AR like one guy successfully did. He went to another country for the treatment.
My concern with LU-177 is what happened to Great John. John told me that his reaction to the 177 (which killed him), occurs in 10% of LU-177 patients. Do you think LU-177 is more risky than docetaxal?
Thanks for the update. A month ago I spoke to Dr. Okunieff at Shands in Gainesville Florida. He mentioned they were using it for high risk patients only. It sounds like we are finally catching up with European countries.
US laws restricts new drugs to FDA approval. In Germany, they allow doctors to use experimental drugs for patients who have a terminal illness that cannot be treated satisfactorily with an authorized medicinal product (Compassionate Use Law). Because of FDA authorization, the European Medicines Agency can now approve Pluvicto for widespread use throughout Europe as is now allowed in the US. FDA authorization is rigorous and is accepted by all countries. Some countries have another layer of authorization based on cost-benefit analysis.
Patients will be capped at six doses administered six weeks apart, leading to a potential maximum cost per patient of $255,000, the spokesperson added. endpts.com/novartis-radioph...
My husband is in line - It will be intersting to see how long it will take to get an acutal appointment/insurance blah blah... A little leary of going to Ohio State because it's super new to them. OSU just took over the Dayton Physicians Practice that has been working with in the clinical trials with LU177. Curious if LU177 had anything to do with the buy out of Dayton Physicians Practice.
My husband just finished 6 rounds of docetoxel in January. We had one of two scans this week. Psa jumped from 4 to 23. MO says LU-177 wont be available till December. She has referred us to a Dr. Wang for possible clinical trials.... our house is almost done in Mexico. We thought we were just coming for scans and Eligard. MO cancelled CT scan and ordered PMSA scan.
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Overview of 177Lu PSMA trials
News on Pluvicto delayed production 
