Charles, Some good thoughts here. Why are drugs for low-risk patients made by so many companies that are finally stressed?
Also, I have been talking about ACT-Up top actions. I covered AIDS in the early days. They inspired activism on the part of the breast cancer patients. I have suggested patients with prostate cancer (with rising PSAs) rise up angry and have "die-ins" at the American Urological Association to ask for support for transperineal biopsies and at the (Advanced) Prostate Cancer Foundation for at least crumps for localized prostate cancer and AS. Whos with me?
-PHARMA has taken little interest in patients on AS. What was that?
--Has something changed? Is Pharma paying attention to patients on AS? Why? Because our numbers are growing?
--Are you on a personal mission to develop drug therapy for men on AS for low-risk and favorable intermediate-risk prostate cancer?
--Is there a need for that?
--Isn't AS OK by itself? Or are you concerned about risks from this non-drug treatment, such as sepsis from transrectal biopsies?
--How many strategies have you pursued of drug therapies fo patients with low-risk or favorable intermediate risk? and how successful have they been?
--I have heard of at least three. Provenge, Xtandi and Fexapotide. Are there more?
--How successful have they been? What are the strategies with them?
--What did you learn? How promising are they?
--What is your response to Dr. Klotz, who I asked if he could recommend Xtandi: "Long story, but the short answer is resolutely no. Trials like this are bogus in my opinion because they include a decrease in tumour volume as an endpoint, and it is totally predictable that that will occur with a cyto-reductive agent."
--What are the toxicities? Are they worth the trouble?
--Is it ethical to give a potentially toxic drug to men who typically receive no active treatment?
--What would the cost for these meds if implemented? $150k/year?
--What do you think the future holds for patients with low-risk and favorable intermediate-risk PCa?
What does decreased risk of progression really mean? Do we have hard scientific data that this decrease in progression actually saves lives or are we back to manipulating statistics and doublespeak?
It's good to see that drug companies are starting to look at AS patients as a source of future revenues. As more men join theAS revolution and our numbers grow this should increase our influence with drug manufacturers.
Wouldn't it be wonderful if someday there is a medication available that has minimal side effects that will keep us on AS.
Neal Shore also was a clinical trial center participant in Fexapotide which showed good results slowing advancement of low risk PCa patients on AS. Fexapotide has no side effects but has recently been turned down by FDA for it's NDA (new drug application). The company (NYMX) didn't have enough long term safety results (6 years). A lot of us would like to try Fexapotide with NO side effects but we aren't interested in expensive chemical castration drugs (Xtandi) with serious side effects. I personally spoke with one Fex sites' clinical trial manager and she said it didn't work for treating BPH but it did work at slowing progression of prostate cancer in low risk men. She said sarcastically, "It will never get approved or take forever". My stock in NYMX cratered the day FDA turned back Fexapotide. At least I added my 2 cents for the fight for a non-toxic treatment. (Link to Fexapotide study below)
If a person on AS wants to slow progression of a slowly progressing cancer, I would recommend using intermittent 50mg or less of bicalutamide (casodex is the brand name). A month's supply of 50 mg bicalutamide is only about $10.00 with most insurance or medicare. Hitting a GS 3 + 3 with enzalutamide is like squashing an ant with a sledge hammer.
Charles, Some good thoughts here. Why are drugs for low-risk patients made by so many companies that are finally stressed?
Also, I have been talking about ACT-Up top actions. I covered AIDS in the early days. They inspired activism on the part of the breast cancer patients. I have suggested patients with prostate cancer (with rising PSAs) rise up angry and have "die-ins" at the American Urological Association to ask for support for transperineal biopsies and at the (Advanced) Prostate Cancer Foundation for at least crumps for localized prostate cancer and AS. Whos with me?
I will speak to Dr. Shore on Monday afternoon.
Do you have any questions for him?
Here's what I have so far:
-PHARMA has taken little interest in patients on AS. What was that?
--Has something changed? Is Pharma paying attention to patients on AS? Why? Because our numbers are growing?
--Are you on a personal mission to develop drug therapy for men on AS for low-risk and favorable intermediate-risk prostate cancer?
--Is there a need for that?
--Isn't AS OK by itself? Or are you concerned about risks from this non-drug treatment, such as sepsis from transrectal biopsies?
--How many strategies have you pursued of drug therapies fo patients with low-risk or favorable intermediate risk? and how successful have they been?
--I have heard of at least three. Provenge, Xtandi and Fexapotide. Are there more?
--How successful have they been? What are the strategies with them?
--What did you learn? How promising are they?
--What is your response to Dr. Klotz, who I asked if he could recommend Xtandi: "Long story, but the short answer is resolutely no. Trials like this are bogus in my opinion because they include a decrease in tumour volume as an endpoint, and it is totally predictable that that will occur with a cyto-reductive agent."
--What are the toxicities? Are they worth the trouble?
--Is it ethical to give a potentially toxic drug to men who typically receive no active treatment?
--What would the cost for these meds if implemented? $150k/year?
--What do you think the future holds for patients with low-risk and favorable intermediate-risk PCa?
John, our numbers are growing. 60 percent and climbing. As Helen Reddy said our numbers are too large to ignore.
I'd agree with the overkill comments on this. Plus the sample size seems too low. But I like the fact that AS is being taken more seriously.
Supposedly, Gleason 3+3 doesn't progress.
Should we take powerful medicine to "fight" cancer when AS can do it?
Nice reporting Howard. There were side effects?
What does decreased risk of progression really mean? Do we have hard scientific data that this decrease in progression actually saves lives or are we back to manipulating statistics and doublespeak?
Thanks, Martin. I got some interesting feedback. I plan to do more.
Yo back, Robert.
I am getting some interesting feedback on this. Look for some follow-up. Thanks. Howard
Great piece. My question exactly after I read the post.
It's good to see that drug companies are starting to look at AS patients as a source of future revenues. As more men join theAS revolution and our numbers grow this should increase our influence with drug manufacturers.
Wouldn't it be wonderful if someday there is a medication available that has minimal side effects that will keep us on AS.
Thanks, Charles. So what do you think of the future of meds for AS? Overkill?
Thanks, Steve. Are you an MD? I plan a follow-up story.
Neal Shore also was a clinical trial center participant in Fexapotide which showed good results slowing advancement of low risk PCa patients on AS. Fexapotide has no side effects but has recently been turned down by FDA for it's NDA (new drug application). The company (NYMX) didn't have enough long term safety results (6 years). A lot of us would like to try Fexapotide with NO side effects but we aren't interested in expensive chemical castration drugs (Xtandi) with serious side effects. I personally spoke with one Fex sites' clinical trial manager and she said it didn't work for treating BPH but it did work at slowing progression of prostate cancer in low risk men. She said sarcastically, "It will never get approved or take forever". My stock in NYMX cratered the day FDA turned back Fexapotide. At least I added my 2 cents for the fight for a non-toxic treatment. (Link to Fexapotide study below)
https://link.springer.com/article/10.1007/s00345-020-03127-w?wt_mc=Internal.Event.1.SEM.ArticleAuthorAssignedToIssue&utm_source=ArticleAuthorAssignedToIssue&utm_medium=email&utm_content=AA_en_06082018&ArticleAuthorAssignedToIssue_20201205
If a person on AS wants to slow progression of a slowly progressing cancer, I would recommend using intermittent 50mg or less of bicalutamide (casodex is the brand name). A month's supply of 50 mg bicalutamide is only about $10.00 with most insurance or medicare. Hitting a GS 3 + 3 with enzalutamide is like squashing an ant with a sledge hammer.