Treatment naïve and clinical trials....
I am asking this question for a friend. Does anyone here know of anyone who is treatment naïve who has entered into a clinical trial?
Some folks who have opted to treat a cancer diagnosis "alternatively"may at some point be interested in entering a clinical trial because a new drug may be a better choice for them then current standard treatment. Has anyone here heard of a clinical trial that admits treatment naïve patients?
Treatment naive with what diagnosis? Metastatic? Advanced PC? Localized? Risk level?
One friend was diagnosed with Gleason five, localized.....The other was diagnosed with Gleason nine, metastatic (lymph nodes and bone)
You mean Grade Group 5 (GS9 or 10) ? - there is no such Gleason score as 5 anymore.
Your friend who was newly diagnosed with metastatic bone cancer should look at PEACE1:
prostatecancer.news/2021/05...
STAMPEDE (UK) runs more clinical trials than anyone for men with newly diagnosed metastatic PCa.
How many bone metastases does he have and where are they located?
Thank you so much. I will pass the information along. He has bone metastases from the pelvis to the skull all along the spine and ribs, too numerous to count....I will find out more accurate information from the other friend who has localized pC.
I am reading through the link that you recommended and this may seem like a stupid question but what is meant by " de novo"patients?
"The two STAMPEDE trials recruited almost entirely (95%) de novo patients."
It means they were newly diagnosed with metastases.
My husband was diagnosed with Stage IV metastatic prostate cancer last year and was in a treatment naive Phase 2 clinical trial for an immunotherapy drug. To do the trial he had to do ADT and chemotherapy, along with the immunotherapy drug. Since he was going to do ADT and chemo as SOC, he decided to do the clinical trial to see if this drug might work. Unfortunately, he had an adverse reaction (stomatitis) to the drug and was taken out of the trial in May of this year. He started the trial/treatment in August, 2020. The link to the trial is below. The trial is still recruiting patients. By the way, he is the only man so far in the trial to have that particular reaction.
clinicaltrials.gov/ct2/show...
Thank you! I will pass the information along and the link to the clinical trial.
I see the Phase 2 Trial is being conducted at Beth Israel, and Dana Farber. Both Hospitals are in Boston. Did you have to go there for all 6 Docetaxel injects? Also the Ivulumab is every 3 weeks, also need to be in Boston?If yes, that is at least 12 plane flights plus Hotel etc for someone out of area.
No, we did this from Tampa (Moffitt Cancer Center). We did not have to go to Boston. Even though the trial is run out of Dana Farber, your local cancer center can still participate. All the lab & scan results are sent to them. We didn’t know anything about trials and that you can participate remotely until Steve got cancer and his oncologist told us about it.
I am very skeptical about Dana Faber I get the impression that they are in the business of supplying human Ginny pigs to pharmaceutical companies for untested drugs. Had a terrible experience there that wound up killing my wife These drugs and procedures haven’t even been tested on animals. Use only as a last resort
There are many trials, but I'm curious as to whether or not these patients have bothered to seek out a Medical Oncologist who would be able to point them in the right direction. They obviously have had diagnosis... But from whom?
Bottom line is once the word "Cancer" is used in the form of "You Have" it... The very next step is getting to a Major Cancer Center and one of Excellence!!! It is there you will get an accurate 2nd opinion to the first, additional testing if necessary, and access to the best treatment modalities and trials! These cancer hospitals will also have a multitude of supporting groups whether it be dietary, stress management, alternative medicine, etc. All related to not only just treating the cancer, but the mind and body as well. Don't skimp, and travel if you must, but get to one of these Center's of Excellence! Local facilities cannot compete, sorry.
Best Regards
I was treatment naive when I entered a trial at MD Anderson. Great experience with frequent monitoring (scans). Find a treatment center of excellence. Get a couple of opinions choose the location you are most comfortable. Good luck to both of your friends.
Thanks to all of you! This forum is truly a gold mine of information and you guys are all so helpful!
Farmhand,
AI clinical trials may be in the category.
Result of patient data and AI has resulted in a test at the very start of treatment to determining if the use of ADT will benefit the new patient, rather than just following the SOC rules of Gleason score alone. That is they have found some low Greason patients could have benefited from early ADT while some high Gleason suffered the AE of ADT for little gain. This was called PANDA I believe.
endocrinologyadvisor.com/ho...
I am sure there are other examples. Hope this leads to an informative thread.
Buddy
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