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finasteride prevents PCa by 25% in 7 years and by 30% over 18 year follow up. At cancer.gov and conducted by the NIH

George71 profile image
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Since many are not aware of this trial ... I thought it beneficial to make it a post of its own.

cancer.gov/news-events/canc...

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George71
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cujoe profile image
cujoe

George, this Charles "Snuffy" Meyers study I posted 2 years ago looks specifically at dutasteride use in patient who had PSA-only non-metastatic recurrent PCa.

The following from the study also indicates a similar potential positive benefit for 5-ARI meds dutasteride and finasteride for people with less agressive PCa:

Conclusions: Dutasteride slows PSADT in PSA-only recurrent prostate cancer. This decline correlated with time to disease progression with close to 50% progression free at 10 years.

Patient Summary: Men with PSA-only recurrent prostate cancer on dutasteride experience a significant drop in the rate at which the PSA increases. If the PSA does not double between months 3-12, they are likely to remain free of metastases for many years.

Here is a link to the full study

Impact of Dutasteride on PSA Kinetics and Time to Progression in Men with PSA-only Recurrent Prostate Cancer - Charles E Myers, Michelle S McCarthy - TFCR&E - posted pre-pub May 5, 2021.

medrxiv.org/content/10.1101...]

And one to the earlier post:

Impact of Dutasteride on PSA Kinetics and Time to Progression in Men with PSA-only Recurrent Prostate Cancer - medRxiv - pre-pub May 5, 2021

cujoe• 2 years ago•24 Replies

healthunlocked.com/fight-pr...

While no treatment is appropraite for everyone, sharing research and our n=1 experiences gives other patients information to make intelligent judgements about their treatment decisions. So, keep it coming and please disregard the negative chatter.

Ciao, Captain K9

George71 profile image
George71 in reply to cujoe

Thanks, cujoe,

Many PCa people don't know:

"Dutasteride slows PSADT in PSA-only recurrent prostate cancer. This decline correlated with time to disease progression with close to 50% progression free at 10 years."

And prevents PCa at a rate of 25%. They can't say that about any other treatment.

ADT causes crpc over time and does not prevent PCa --- nor does it improve OS to any meaningful extent.

Snuffy and Dr. Bob were prescribing Avadart (and using testosterone replacement) over a decade ago with surprising results based on the NIH clinical clinical trial I posted above.

I have been taking Avadart since late 2016 and can say it really made a difference for me. It only knocks out the DHT and leaves the testosterone for use throughout the body (unlike Casodex which blocks both testosterone and DHT from entering all cells -- with Casodex, you have testosterone but you can't use it ... just a slower route than ADT to crpc). Avadart will not cause crpc... men were on it for 18 + years Avadart helps prevent PCa.

George71 profile image
George71 in reply to George71

Here is a video of Snuffy 2012 -- I am doing his protocal -- Avadart and testosterone replacement

askdrmyers.wordpress.com/20...

maley2711 profile image
maley2711 in reply to cujoe

So,, how does this stack up in comparison to ADT for men who find themselves with PSA recurrent non-metastatic PCa? Are there any claims for its use in metastatic men?

George71 profile image
George71 in reply to maley2711

Yes -- it is well known since before 2000 --- watch the video I posted above. from Snuffy .... also Dr. Bob had dozens of patients with very late stage mPCa on nothing but Avadart and constant high testosterone cream.

George71 profile image
George71 in reply to George71

here is another snuffy video:

askdrmyers.wordpress.com/20...

George71 profile image
George71

In my opinion, (as cujoe stated above: "While no treatment is appropriate for everyone, sharing research and our n=1 experiences gives other patients information to make intelligent judgements about their treatment decisions") Snuffy and Dr. Bob were 20 years ahead of SOC. Only 3 or 4 years has there been a shift toward IADT / BAT / testosterone replacement etc. etc.

There are many doctors finally coming around to realize that ADT or castration doesn't extend overall survival -- All forms of continuous ADT lead to crpc in most men within 3 to 5 years -- ADT causes and accelerates mets and migration of PCa -- increases instances of dementia, bone density loss -- heart disease due to loss of all usable testosterone..... even in people with rapid PSA doubling time of 6 months and doubling time of 10 months and no ADT live over 10 years before mets. can be seen on conventional ct scans.

George71 profile image
George71

"Johns Hopkins Hospital and Walter Reed National Military Medical Center who experienced BCR after radical prostatectomy and delayed ADT initiation until metastasis. Median metastasis-free survival (MFS) was 144 months and 192 months from the time of local treatment in men with a PSA doubling time of less than 6 months and less than 10 months, respectively, the investigators reported in The Journal of Urology. Median overall survival (OS) from the time of local treatment was 168 and 204 months, respectively. Older age, higher pathologic T stage, higher Gleason sum, and faster PSA doubling time were all associated with higher likelihood of death."

“Men with biochemically recurrent prostate cancer, who defer hormone therapy until metastasis have overall survival that is quite long, and the early initiation of continuous androgen deprivation therapy for biochemical relapse may not meaningfully improve overall survival,” Dr Marshall’s team wrote. These data underscore the need to reevaluate when to start primary ADT in this patient population, the investigators highlighted.

In an accompanying editorial, David VanderWeele, MD, PhD, and Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center at the Northwestern University Feinberg School of Medicine, in Chicago, Illinois, agreed that the risks of early ADT in men with biochemically recurrent prostate cancer may not outweigh the benefits:

These data provide context for patients with BCR and providers on whether to undergo ADT for years despite unproven benefit and quality of life impact. New imaging may help or further add to the controversy, since BCR patients may have metastases on newer imaging. Until definitive data are available, men with BCR should be counselled regarding the lack of data to support ADT benefit in nonmetastatic BCR.

renalandurologynews.com/hom...

GeorgeGlass profile image
GeorgeGlass in reply to George71

This info is rather upsetting. If this is accurate, that means that I could have been running around living a normal life, including sex etc, instead of feeling like a zombie. Why isn't this being talked about more?!

What doctor prescribes Dutasteride or Finisteride? Derm? or Oncology or PCM? Which is more effective, Dutasteride?

George71 profile image
George71 in reply to GeorgeGlass

excellent video Dr. Snuffy Myers treatment of BCR after surgery or radiation -- Olig mets -- radiation.

youtube.com/watch?v=_U9rxGA...

George71 profile image
George71

medscape.com/viewarticle/89...

"New Data: Finasteride Safely Prevents Prostate Cancer"

Will a presentation here at the American Urological Association (AUA) 2018 Annual Meeting be a turning point in the reputation — and use — of finasteride for the prevention of prostate cancer?

Ian Thompson, MD, hopes so.

The eminent urologist and researcher reported, during a plenary session, that the daily use of finasteride, the commonly prescribed hormone-blocking agent, does not elevate the long-term risk for prostate cancer death.

Dr Ian Thompson

"Very long-term follow-up" shows that finasteride "is safe," Thompson, who is professor emeritus at the University of Texas Health Science Center at San Antonio, said in a press statement.

"These results are transformational," he explained. "We have found an inexpensive, effective drug that can prevent [prostate cancer]."

The new findings about prostate cancer deaths, from the landmark Prostate Cancer Prevention Trial (PCPT), might seem incongruous at first.

After all, finasteride was so effective in reducing the risk for prostate cancer in that study that the placebo-controlled PCPT was stopped early and the results were published in 2003 in the New England Journal of Medicine.

But that is also when the troubles began, because the investigators simultaneously reported an increase in the number of high-grade cancers with the drug, compared with placebo (280 vs 237).

That finding irreparably tarnished finasteride, said Thompson, who is principal investigator of the PCPT.

"There is no question that the reason finasteride is not used for prostate cancer prevention is because of the small but statistically significant increase in high-grade disease. Absolutely no question," Thompson told Medscape Medical News.

But new data address this old finding.

If high-grade disease is more common with finasteride than with placebo, "there should be more prostate cancer deaths [with finasteride]," he explained.

But that's not what the researchers found in their new analysis. Instead, there were fewer prostate cancer deaths in the finasteride group than in the placebo group (42 vs 56).

The median follow-up was 18.4 years, and the cumulative follow-up was almost 300,000 years.

"We have no evidence that there's an increase in prostate cancer death in the finasteride arm," Thompson said. In other words, the initial study findings about an increase in high-grade disease are not consequential.

The new data took 5 years to gather, Thompson reported.

PCPT investigators matched more than 18,000 trial participants to the National Death Index, a centralized database of American death records. With this painstaking process, they were able to determine whether a trial participant had died and, if so, the cause of death.

The lion's share of this laborious work was performed by Phyllis Goodman, MS, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle, who is a member of the PCPT team, Thompson noted.

We have answered the questions and closed the book.

With these latest data, which come 25 years after the PCPT trial was started, "we have answered the questions and closed the book," Thompson said. It was in 1994, when he was just 39 years old, when he was named principal investigator of the study.

The PCPT is "one of the most powerful and important cancer prevention trials ever conducted," said Joseph Smith, MD, editor of the Journal of Urology, when he introduced Thompson at the plenary session.

The trial, sponsored by the Southwest Oncology Group, was designed to determine whether daily finasteride for 7 years would prevent prostate cancer in men older than 55 years. The first 5-alpha-reductase inhibitor — which targets and blocks the action of androgens, including testosterone — is approved to treat the symptoms of prostate enlargement and male pattern baldness.

As reported in 2003, the risk for prostate cancer over the initial 7-year study period was 25% lower with finasteride than with placebo. That risk reduction now "goes out to 16 years, at least," said Thompson.

However, more "relatively modest" sexual adverse effects have been consistently reported with finasteride than with placebo.

In affected men, "it's like being maybe 3 years older," he told the AUA audience. The trial also showed that the risk for gynecomastia was higher with finasteride than with placebo (4.5% vs 2.8%). And, notably, the drug has not been shown to improve overall survival.

A New Day? Two Doctors Comment:

There is an "astonishing" level of interest in the prevention of prostate cancer, said Thompson. Clinicaltrials.gov has a long list of agents under investigation, such as metformin, statins, aspirin, and green tea.

But none of the studies, which are all relatively small, will ever be as authoritative as the PCPT. "You can prevent a quarter of all prostate cancers with finasteride," he pointed out.

Who uses it today? Almost nobody.

"Who uses it today? Almost nobody," said Thompson.

The chemopreventive agent, which is now generic, costs about $48 to $108 a month.

Abouassaly then gave finasteride — and the concept of prostate cancer prevention — high praise: "Looking at the data today, I would consider taking finasteride daily."

However, by that time, the black-box warning issued by the US Food and Drug Administration had destroyed the reputation of finasteride.

The effect of the initial high-grade cancer finding is a "sticky fact," said Thompson.

"It stuck since the first publication and, despite compelling evidence that the drug actually improves the detection of cancer and high-grade disease [because it shrinks the gland, making detection easier], it remains sticky," he explained. "It will be interesting to see whether you can unstick a fact."

The National Cancer Institute and the National Institutes of Health funded the study. Dr Thompson, Dr Eggener, and Dr Abouassaly have disclosed no relevant financial relationships.

cujoe profile image
cujoe

George - Thanks, once again, for taking the time to put out information worthy of consideration by a large percentage of PCa patients. The challenges to SOC seem to be mounting on several fronts and the docs (and patients) who were exploring territories at the edge of SOC are continually being shown to have paved the way for much needed changes and adjustment to SOC. Have a great weekend. Paz - K9 terror

George71 profile image
George71

The major difference between Avadart/finasteride and ADT:

Some forms of ADT treatment prevents the making of testosterone entirely (lupron) ... other forms block the cell receptors from getting testosterone (Casodex). Continuous use of either/both leads to crpc., increased probability of heart issues, dementia, bone loss, sexual ability, diabetes etc.

Avadart on the other hand does not cause crpc or any of the other side effects that ADT does... with Avadart your body makes and uses all your testosterone --- avoiding increased probability of heart problems, diabetes, bone loss etc etc. Avadart only prevents testosterone from being converted to DHT.

The study was predicated on the fact that men with a genetic defect of not being able to convert testosterone into DHT -- never get prostate cancer.!!! It is the only observed difference in those men -- other than they didn't get male pattern baldness.

From what my research can find -- most institutions are coming to the realization that ADT should not be given until mets show up on conventional ct scan (not on PSMA) .. and then only short IADT . get off -- take Avadart wait till PSA raises back to where it was at the time of IADT and take for 3 months or till PSA drops back then repeat ... the process could extend doubling time by years and avoid the chance of developing crpc which is the last thing you want to happen.

maley2711 profile image
maley2711 in reply to George71

so, if ADT is of no benefit, and in fact testosterone is not a growth factor for PCa, why care if PCa is CR or not? ADT is simply a worthless approach??? In fact, a dangerous approach?

I believe I have previously read that study re doubling time and detected metastasis. There must be ? studies that showed a benefit to early ADT.

I do know this one thing....for my diagnostics , including one core of 4+5 at biopsy, and all others besides one 3+3 were benign, PCa mortality at 15 yr without initial treatment(but perhaps later treatment,eg when PSA start rapidly increasing or imaging shows metastasi, or perhaps physical symptms) was 25%, and 12% for men who accepted initial treatment. If a man is 50 and sees those numbers, treatment may be more attractive than for a man who sees those numbers at 73?

So, conventional ADT to accompany initial RT for high risk men....studies show benefit for that approach? Would you hesitate to accept ADT in that scenario??

George71 profile image
George71 in reply to maley2711

Hi maely2711,

In my opinion only.... based on many published studies and looking at all sides --- and after nearly 60 + years and millions of men's history to draw from -- with PCa taking ADT the fact is --- continuous ADT slows the time to visible mets. but does not extend overall survival and routinely leads to crpc in around 3 years on average and has many damaging irreversible side effects. I wish that weren't true but it is.

That is why so many doctors and patients are trying other approaches to SOC. SOC is mostly different versions of the same thing -- ADT .

In my opinion only, there may come a time to start a short round of IADT (the type that temporarily stops the production of testosterone -- but not the ability to use testosterone).... But, for the majority of non metastatic PCa patients, the use of ADT is many many many years away if ever from the first failed try for complete eradication (cure) from PCa (ie. surgery or radiation).

Of course if someone has tried all the options and has extensive mets and pain -- then ADT / celebrex / opioid pain relievers etc will certainly help and consequentially extend life a few months.... But when ADT is given years too soon, any benefit is lost and in fact it may shorten life by many years.... ADT brings on crpc / heart disease/ diabetes / bone loss/ dementia etc .. which, until just recently was not admitted but now widely acknowledged by doctors.

Most men who have had surgery as their first attempt are thought (on scans) to have their PCa contained entirely in the prostate gland and are going for a cure. (back in 2016 if they opened you up in surgery and saw it had spread hey would stop the procedure sew you up and put you on lifetime ADT). Once it is determined that the cancer is loose (out of the barn) (detectable PSA post surgery) then either ADT or salvage radiation of the prostate bed and the nearby lymph nodes is the next option. Some RO are doing the whole pelvic lymph nodes in an attempt for a cure even if no evidence on scans ... but that comes at a high risk of possible permanent damage to uro/bowels incontinence etc. Some add ADT for 6 months others insist on 2 years ADT... based on the individual situation.

I wanted to do radiation in the beginning -- my dad had old style weak and fuzzy radiation to prostate -- (No ADT --- ADT was not generally used with radiation back in early 70"s) and he lived to be 101 -- by then his PSA was around 6. Both my uncles lived to 97 and 100 -- both had PCa and weak, fuzzy radiation -- nothing else...

Nowadays it seems they are going backwards.

Because of their great outcomes, I wanted radiation but eventually opted for surgery because at the time (2016) no large institution PCa RO would do radiation without lupron for at least 2 years -- if I could have found one I would have done radiation) .... Now in 2023 many will do first time radiation or salvage radiation with only 6 months ADT and some with no ADT at all.

It is likely many of us surgery patients might have been effectively cured with radiation had we done it first -- in which case they could have radiated the prostate / the prostate bed, and the nearby lymph nodes -- up front -- and gotten any micro mets that were nearby, which surgery would miss... . It would have gotten the nearby spread. Surgery has to get every speck, or you are left with radiation anyway.

Post surgery, salvage radiation is much more risky with the bowels and uro track exposed -- no way to protect them from radiation -- my Uro Onc said almost certain ED and incontinence. I would do it if they can see where to spot radiate -- but for now shooting the whole pelvic area in the blind before necessary and risking permanently wrecking everything and likely not getting every last speck at this point, is not an avenue for me.

I read your history -- you are better off than I was/ am and better off than most here... 2 cores one with G6 and the other G9 with only 10% cancer --- your situation shows that (apparently) even with very little cancer, it still had gotten outside the prostate since you have a rising PSA. Your situation is much like mine.

You can read my history --- Gleason 4+4 - 8 -- pre surgery biopsy 7 or 8 cores with PCa some 70% --- post surgery pathology report 4 of 12 lymph nodes had PCa. immediate PSA failure 0.033 -- Several Dr's opinion was to immediately put me on lifetime ADT.... Many who went that route aren't with us anymore.

As the research shows -- it is likely 8 to 10 years before mets appear with no symptoms other than a rising PSA -- that is with people with a PSA doubling time of 6 months and 10 months ... It would seem that men in their late 60's would likely outlive PCa with minimum treatment -- especially since it is often debilitating and has very short benefit in overall survival -- if any -- maybe even shorten it.

I think Avadart / Mediterranean diet / proven supplements / and exercise would be worth a try for a few months -- if PSA slows to a crawl as mine has -- you could last for decades --- make it a chronic disease ... that is at best all that ADT can do either. Hopefully Immuno therapy will make a breakthrough soon.

maley2711 profile image
maley2711 in reply to George71

Could you perhaps clarify your thinking re the last paragraph? suggesting do conventional adt only if metastasis detected..by PSMA or ct and bone old tech? and when starting adt after metastasis , only do IADT? where does avodart fit in that scenario....i can't seem to clearly understand what you say about that? BTW, having watched Snuffy videos, seems to me he does not completely naysay a role for conventional ADT? nor does he claim any cure by using avodart,etc..pCa can still multiply even if deprived of DHT evidently? were it that simple!!!!!!!!!!!!!!!! miracle cure!!!!!!!!!!!!! I guess it could be renamed DHT deprived resistance?

anyway, lots of theories, but only well-conducted studies should guide us?

George71 profile image
George71

I agree with your thought that -- "If a man is 50 and sees those numbers, treatment may be more attractive than for a man who sees those numbers at 73?"

nevertheless even in the case of a 50 year old: (1) in this day and age, with the clear advances in cancer research (2) the certain to come immuno therapy breakthroughs probably in the next 5 to 7 years (3) the fact that the current ADT SOC approach shows little if any benefit. ..... Even a 50 year old post surgery or radiation --- with rising PSA, and no mets and 6 months doubling time, would likely live decades, with no treatment at all. (and, initial surgery or radiation followed by Avadart / med diet / exercise /and proven supplements is not nothing by a long shot).

I see where many men who have merely BCR PSA at 0.2 (post surgery or radiation) with no mets be instantly put on multiple ADTs.... They reach undetectable PSA for 4 or 5 years then the cancer mutates and becomes crpc in almost every case ... (many doctors are recognizing the problem and are doing vacations from ADT -- but the problem with that is, often times the testosterone does not come back for a year or more ... and it progresses to crpc anyway). ADT can not cure anyone.

In my opinion, based on the research, being in your late 60's early 70's, having a an natural PSA of 5.0 or 10.0 that doesn't double but every 2 years .. is virtually like being cured.

I was told by one doctor that a PSA of at least 30 is required to show in the bones on conventional scans and would almost certainly be asymptomatic.

NIH told me that even now, after 7+ years -- with no mets visible on PSMA scan I would almost certainly be 5 to 10 more years before it shows on conventional scans... or have any symptoms.

The thing is, when you take Avadart (which is even better at blocking DHT than finasteride) it doesn't cause crpc mutations --- ADT makes it look like cancer is under control -- when it is actually mutating and will be much more aggressive fast spreading and difficult to control.

Did you watch the videos of Snuffy?

askdrmyers.wordpress.com/20...

maley2711 profile image
maley2711 in reply to George71

Thanks George...I did watch ! Initial PSA was 7.5, once dipped to 6.5, and then 2 more PSAs at 7.5..the last approx 1 1/2 years ago...I am now at beginning of year 5 since I saw the Uro for 7.5 PSA...Kaiser uses 6.5 for men age 70 and up. At my ROs repeated suggestion, I believe I'll have blood taken in several weeks.....terrified of course of bad news with Gleason 4+5 !!! My friend listened to my explanation of treatments.....both his parents were Docs and he and his nurse practioner wife are no dummies........ he suggested not arguing with the RO re the concurrent use of ADT for 18 months...try it and if tolerable, continue, or refuse additional ADT and finish RT (with whole pelvic) without, or soon after? there is no doubt studies show benefit of ADT added to RT, but I can't recall which endpoints showed clear advantage......which brings up another subject....should we care most about time to BCR, metastasis( PET or other?), PCa specific survival rate at 5-10 years, or OS at 5-10 years?

You seem to be saying that ADT with RT may be risking earlier metastasis???? If I could talk him into it, do RT plus Avodart? I have forgotten what I probably read about the proposed mecahnism by which ADT enhances RT effectiveness? 4 years of Googling PCa topics has just about destroyed my little brain!!! Ever had that feeling?

Also, some here warned me severely about RT without markers/fiducials....but I can't find anything definitive absoluting proving that there is significant value compared to just daily CBCT soft tissue and bone alignment.....interesting that another approach for some men could be visible prostate calcium deposits? My Kaiser RO, rated highly by a national rating system and supposedly by local fellow Docs, said that they use fiducials fo SBRT but not 28 day hypofraction with VMAT and CBCT onboard I guess. There is one hospital here who does Viewray MRI real-time guided RT, but very much doubt Kaiser would approve that non-Kaiser treatment...and SBRT is still evidently at the clinical trial stage as far as the powers that be are concerned..UCLA having great results with Viewray for high risk.

You can imagine my worry that I have studied my way to metastatic stage, and friends and family will be sighing behind my back...I have some who really do care about me!!! My official diagnosis was just 18 months ago, anda PSMA PET was clean 12 months ago..so good reason for optimism???? Geez.it's just worrisome, thinking about my current good state of health, and have significantly reduced my QOL perhaps almost immediately for an unpredictable benefit???

You know , the RO said this...answering my question about need for ADT with RT.... " well, you can do it now(with RT) or later " I don't think that is true George? Thestudies show a benefit, but not that RT without ADT is certain failure????

Excuse my rambling !!

George71 profile image
George71 in reply to maley2711

Hi maley2711,

see the most recent post about Polaris -- I had it done in 2016 -- I was " less aggressive than average AUA intermediate risk" -- if I did nothing for 10 years chance of dying was 7%. it was graded "less aggressive" with a score of 2.5

They test your biopsy and grade it to see if you should skip the ADT if you were to opt for radiation... The article was just published on the 23d -- four days ago.

prostatecancernewstoday.com...

"Prolaris — a genetic test that predicts the aggressiveness of prostate cancer — can accurately identify which men with intermediate- or high-risk disease will benefit from adding androgen deprivation therapy (ADT) to standard radiation therapy, a study shows.

This Myriad Genetics’ test was found to be superior to other methods at predicting cancer spread (metastasis) in these patients, and thereby at distinguishing those who could avoid ADT.

The findings, “Association of the clinical cell-cycle risk score with metastasis after radiation therapy and identification of men with prostate cancer who can forgo combined androgen deprivation therapy,” were shared in an oral presentation at the 2021 Genitourinary Cancer Symposium, held virtually Feb. 11–13.

“This new data helps distinguish the most appropriate personalized treatment path for each patient based on how their specific tumor is behaving,” Jonathan Tward, MD, PhD, the study’s first author and an associate professor in the department of radiation oncology at the University of Utah, said in a press release.

“For some men, this means being able to avoid overtreating patients with therapies including hormone treatment that can momentously impact their quality of life, while still appropriately treating their prostate cancer,” Tward added.

Todd Cohen, MD, the vice president of Myriad’s medical affairs for urology, said that the company was the first to offer “a test that directly measures the molecular biology of an individual patient’s prostate cancer.”

“This study by Dr. Tward and his team is another strong validation of the prognostic power of the Prolaris test and our ongoing commitment to providing healthcare professionals with the tools needed to determine the most effective treatments and monitoring strategies for each patient,” Cohen added.

Prolaris predicts cancer aggressiveness by analyzing the activity of 46 genes involved in cancer cell proliferation, using tissue collected during a biopsy to confirm a cancer diagnosis or during surgery to remove the prostate.

It then combines this information with the patient’s Gleason score — a measure of prostate cancer aggressiveness based on how cells look under a microscope — and levels of prostate cancer antigen, a biomarker of prostate cancer.

The result is a so-called combined clinical cell-cycle risk (CCR) score, which can be used to better predict the likelihood of prostate cancer progression over 10 years. A more accurate prediction allows for more precise treatment, avoiding excessive treatment that both raises the risk of side effects and care costs.

In previous research, Prolaris was shown to help identify those men with apparent low-risk disease who may safely opt for active surveillance only — meaning, no treatment until the detection of disease progression — and those who may need extensive treatment.

Other studies have highlighted the test’s potential in identifying men with intermediate or high-risk prostate cancer who could avoid additional and intensive therapy, such as ADT, when choosing radiation therapy, or radiation therapy when choosing surgery.

In 2020, a guideline update from the National Comprehensive Cancer Network included Prolaris as one of two tests recommended to guide treatment for men with unfavorable intermediate- and high-risk prostate cancer.

Now, Tward and colleagues evaluated if Prolaris also could predict the benefit of adding ADT to radiation therapy in men with unfavorable intermediate- or high-risk prostate cancer.

They retrospectively examined clinical data covering 718 of such patients, all given dose-escalated radiation therapy either alone or in combination with ADT, and who were followed for a median of 5.9 years.

The team evaluated the ability of the CCR score — with a high-risk threshold of 2.112 — to predict the development of metastasis in patients treated with single or combination therapy.

Results showed that men with CCR scores below the high-risk threshold had a 10-year risk of metastasis of 4.2%, while those with a score greater than the threshold had a risk of 25.3%.

Notably, among men with a CCR below threshold score, adding ADT to radiation therapy resulted in no significantly greater benefit relative to radiation therapy alone (4.2% vs. 3.9% 10-year risk of metastasis).

Data also highlighted that about 50% of men with unfavorable intermediate-risk prostate cancer and 20% of those with a high-risk disease may have CCR scores below the risk threshold, and could safely consider radiation therapy alone.

“Men with scores below the [high-risk] threshold may not significantly reduce their 10-year risk of metastasis with the addition of ADT,” the researchers wrote in the abstract.

In addition, the CCR score was found to be superior to other risk-stratifying approaches at predicting metastasis in these patients, and therefore guiding treatment.

These findings suggest that the Prolaris test can be used to identify which men with intermediate-risk or high-risk prostate cancer may benefit from additional hormonal treatment and those who may avoid it.

According to Myriad, about 60% of prostate cancer patients in the U.S. currently have insurance or Medicare with access to Prolaris."

maley2711 profile image
maley2711 in reply to George71

Thank you Gene! So kind! Yes, I've been aware of that, they combine the Polaris score with the CAPRA nomogram score( developed at UCSF) to arrive at CCR score. My CAPRA is high intermediate, just below low high risk. of course you know about Decipher and I believe Oncotype? The problem is...from what I have read on their websites about the details, my 10% 4+5 single core would be insufficient tissue for the test ..each core is 10-15 mmm, I think the average maybe 10mm= 2/5"...so 10% of that is VERY little.

I have sent messages to both companies asking about this, but no replies. I guess I should call them, but the details on their websites seem clear on the tissue requirement.

I do have a slide from a Doc's video presentation on PCa...shows 88% survival at some time frame(10yr?) with no ADT, vs 92% with ADT. I'm guessing you'd take yor chance with no ADT if those are true numbers?????

I have not researched Avodart plus radiation...if ever tried?

I have read amd you stated, that studies show ADT delays detectable metastasis after BCR., but doesn't improve OS. Why do you think that is? The SEs of ADT results in earlier other causes of death??? On th e heaart issue, I asked the RO.....he said studies inconclusive, and I must say that is what I have seen when I reserch the topic....some slight increase in heart problems if patient has already had CV problems...so in that case they suggest to involve a cardio during the ADT treatment. I have , for unknown reasons, fainted 3 times in past 10 years..last time after feeling unwell while taking shower....thinking I was OK, finished shower, stepped out , andmy next memory was lying on the floor, naked and peeing all over myself. I thought I had enjoyed a painles death, and that was a good wy to go..then realized I was still alive, and uncontrollably peeing , and didn't even attemp to stop.....took a roll of TP to clean up the mess...evidently when falling I crashed aagainst the toilet, because I had to push it back to correct position over drain!!! Some years ago I wore a heart monitor for several weks....just some minor discrepancy seen, but no big deal per the GP, who didn't think a cardio was needed based on what she saw of the results.....years earlier, I did a stress test, but nurse/tech stopped the test based on something ?? I fel t fine, but treadmill had begun to tire me a little. I walk 3 MPH ...20 minute miles.....2-3 per day the goal. 6' 1"...200 lb...I'd like to reach maybe 185, but not much luck unless I again reduce my cals.

I haven't asked either the Uro or RO what they would do in my situation.....I ususally do ask a provider that question when he/she tries to make me the decider!!! I do know neither is hound ing me to do something.....basically I'm out of sight, out of (their) minds! I know they both are overloaded with patients.....that is the system. Which I think may be one reason some Docs seem to have read less than the patients like you and me have???? Unlike many here and other forums, I have great respect for anyone who makes it thru the rigors of med school, internship, rsidency, etc. I would not have been accepted into med schoo....let alone make it thru that challenge. I do think that probably a lot of young people are naive when they decide to enter medicine..envisioning cures that don't really exist???????

George71 profile image
George71 in reply to maley2711

Did you see my following posts? As for the Polaris article shows that there are recognized patients that do not need and would not benefit from ADT with radiation.

Of course the reason is that they recognize the down side to ADT is not without risk -- and because of your past fainting spells I certainly would not do surgery as well as the outcome is not as good -- according to the article I just posted a few hours ago -- 47% urinary incontinence from surgery and 15% bowel issues from radiation ... And both are questionable as to whether they would increase OS -- with certainly some level of lasting side effects.

George71 profile image
George71 in reply to maley2711

Watch this video -- he talks about PSMA scan -- reduces unnecessary aggressive treatment for high grade prostate cancer.

youtube.com/watch?v=q2bTlh7...

George71 profile image
George71

So if I understand, you have only had a biopsy but no treatment --- no surgery or radiation ? You are about where I was after the biopsy ...

I agree with the advise of your friend ... has any of the doctors @ Kaiser or any you have gotten a second opinion from -- suggested radiation of the prostate plus 3 months ADT .... and radiate the nearby lymph nodes at the same time? (not all pelvic lymph nodes just the nearby chain of nodes) In that case, they will likely get any residual cancer that surgery would not have gotten. As far as the radiation not being precise... (in my opinion) it is likely better being a little fuzzier than super focused RT, for the reason just stated.

As for SBRT or not... the 38 or 45 (how ever many sessions) are less likely to be damaging if one is off line -- whereas if one of 5 SBRT doses is over or under powered or slightly off line could do damage. It really does depend on a good technician. Dr. Michael J. Dattoli in Sarasota Florida is supposedly one of the best and has a machine that follows the prostate in real time when you breath or your intestines move during treatment. I think he still does 30 something sessions / maybe he does SBRT by now... There are likely others nearer to you than Florida with the same capability -- I'm not sure super sharp in this case is beneficial for the reason I mentioned above. If a person were needing to be radiated in an area of the body that extreme accuracy is needed near a vital organ or such -- then that would be different.

I agree with your friend, also about getting the 3 month shot and then telling the doctor you can't tolerate the ADT (which is what I should have done -- I was naive ... I thought they might stop treatment if I did that because they would not precede without me agreeing to 24 months). ADT does make RT more effective ... but you don't want to give the cancer any time to mutate to crpc ... Most Dr's now realize short cycles of IADT helps quality of life / prevents other side effects, heart disease, bone loss, etc In my opinion I would get on Avadart now and stay on it ... get the 3 month Lupron shot and refuse anymore. If you have zero PSA after 6 months or so and your testosterone comes back to normal range maybe cut back to 3 Avadart per week. Remember -- men were on finasteride for 18 + years and Avadart alone reduces PCa cancer risk by nearly 25% over an 18 years followup.

As for surgery as an option--- (1) If even a speck is left behind --- you will be faced with radiation anyway.... (2) You may not be aware but when they do PCa surgery they take out one of your two sphincter muscles... making incontinence more problematic than surgeons let on.

I copied and pasted this from the web: "Controlling the outflow of urine are two valves, or sphincters, located in the bladder neck and earliest portion of the urethra. The bladder neck sphincter is under involuntary (autonomic) control while the urethral sphincter has both voluntary and involuntary components".

As far as waiting too long -- I wouldn't worry about that -- your PSA is not hardly doubling at all .... very unlikely it is anywhere but in your prostate --- 2 cores 10% --- You have a very high chance of being cured.

The things that bothered me were the bleeding from the biopsy and surgery-- I tried to not have to get the biopsy because of the possibility of spreading PCa --- they swear it doesn't do that --- but I'm not so sure. Dr. Kwon's video documented a case where the robotic arm used in surgery apparently deposited PCa near a patients naval. Who knows whether these guys who end up with recurrent PCa 15 years later were caused by the biopsy or bleeding caused in surgery. I talked with an ablation doctor who thinks that is the case....

George71 profile image
George71

If I read it right, you are 5 and a half years since PSA test 7.5 and biopsy ONLY (no treatment of any kind) and your PSA is STILL less than 8 !!!! ---

At that rate ... if you did absolutely nothing... it is likely you will live to be 120 !!

If you did Snuffy's growth arrest protocal ie. nothing but, diet/exercise/over the counter supplements and Avadart, you would likely live to 200 !!! LOL

Your PSA hasn't done anything -- for 5 + years with zero treatment -- that just proves the point !!!

It is a tough decision.... you have the option to go for a cure -- at the cost of possibly urinary and/or bowel incontinence / ED for the rest of your life. It is a low possibility but it does happen more than they admit.

PSA doubling time is the most important factor... slowing doubling time without doing anything that reduces testosterone to castrate levels and inducing the morphing of PCa to crpc is my goal.

Here is my thought --You have a relatively high PSA to only have 2 cores positive and only 10% cancer in each one. There may be some more in the prostate that the needle biopsy missed -- from what I hear, that is not uncommon.

I had a PSA of 8.6 or so when I went to surgery -- it turned out I had cancer in 4 of 12 lymph nodes and 7 or so cores out of a 16 core biopsy... Gleason 8 ....

As you saw in Snuffy's video -- if radiation or surgery fails -- even though it is obviously metastatic but not visible somewhere else than the prostate -- he does Avadart / diet / exercise and supplements and many people live decades with effectively no evidence of disease whatsoever... only if that fails does he do any thing else. If it shows up on scans he radiates it or removes it with surgery depending on where it is found...

Did you watch his video where he said men with a doubling rate of 4+ years would live to be 220 years old ... LOL ... he said a PSA of 500 is usually necessary to pose a threat. He has had patients that had PSA's over 1000 and brought it under arrest /control.

maley2711 profile image
maley2711 in reply to George71

Thanks again George. Just a slight misunderstanding.....probably poor explantion by me. Basically at the very beginning of 2019, I had a PSA of 7.5 when I 1st met with Uro, then I had 2 more...7.5 and 6.5, and ,y last one was 18 months ago, 7.5. So , PSA stayed at approx 7.5 thruout 2019,2020, and at least thru 7 months of 2021, when last was done anda 7.5 just before the biopsy...and we know just 12 months ago PSMA met showed nothing cept mild uptake SUVMax 8.5 in prostate....I thin k one study found a breakpoint of 8 for likelihood of more aggressive cancer? My initial MRI before biopsy , my fusion biopsy outside Kaiser, my ALP test, my T test(550), my DEXA scan, my PSMA test...all were done only because I asked!!!??? Also, at the med school OHSU where fusion biopsy was done, I asked the uro to give me sleep sedation for the biopsy..she refused, and I was unable to endure the pain from the probe insertion, so only then did she agree to sedation for another try on another day!!! Listen to the damn patient!!!!!!!!! and she was supposedly the #1 PCa biopser there!!!

So, my PSA remained stable at approx 7. 5 for 2 1/2 years, and don't know what has happened in last 1 1/2 years...only that PSMA 12 months ago was negative for detectable metastasis. even with the 7.5, remeber that my prostate is approx double the volume of the average man my age...so there would be more PSA even with no cancer. Unfortunately, with the large prostate, could be the reason more 4+5 was not found on biopsy...more samples should have been taken...I asked her, but she refused!!!!!!!!!!!!!!!!!!!! I suppose she had faith they find serious cancer in that PIRADS 5 lesion...she called it a tumor!!!!!!!!!!!!!!

My RO just sent me this in reply to me....

" Hi Dale,

I agree that the goal os to always optimize likelihood of surviving the cancer yet also try to optimize quality of life by minimizing side effects.So, the extent of optimizing both factors (survival and side effects/complications) really depends on the extent of the cancer,location of the cancer, location of cancer bearing tissue in relationship with healthy tissues,other underlying medical issues patients may have and their interplay with the caner treatment . We try exteremly hard to come up with an optimal radiation therapy plan.

We see our patients once a week in a physician-patient meeting during radiation therapy and then do a 3 month follow up with the patient and then urologist takes over and does regular long term follow up as well.

Thanks,

Jai Nautiyal

He was formerly on faculty at U Chicago...don't know if true, but he told me he wanted to get away from the theory and research and actually have the satisfaction of helping people. I think he is mid 50s to early 60s...listed by Castle connelyas one of top-rated ROs in Oregon, etc.

FINALLY, I can research, but do you have handy any links to any studies re use of Avodart for existing PCa? Other than Snuffy's? D on't recall who your insurer is, but is it being covered?

How did you find a physician willing to prescribe? Did you need to show him any research on its use?

This is surely a "trip", isn't it George?

Best for your continued success !!! Dale

George71 profile image
George71 in reply to maley2711

in video below Dr. Scholz talks about surgery vs radiation -- and recommends bachy therapy. In his following video he talks about radiating lymph nodes.

youtube.com/watch?v=bJAHYpT...

George71 profile image
George71 in reply to maley2711

Treating High-Risk Gleason 8: A Modern Approach | Mark Scholz, MD

PSMA changes the approach;

youtube.com/watch?v=q2bTlh7...

George71 profile image
George71 in reply to George71

here is one more: many options

youtube.com/watch?v=KayTwyJ...

George71 profile image
George71

Based on your very enlarged prostate with likely BPH -- a PSA of 7 or 8 is pretty low -- if you ask me. Again Avadart is prescribed for BPH and has almost no side effects or down side men were on finasteride for 28 years in the trial (mainly for BPH and/or hair growth (male pattern baldness).

Mike2023 profile image
Mike2023

I have not yet looked at this trial, but considerable other studies that the PCa prevented at the "easy" ones, but finasteride actually increases the aggressivness of PCa.

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