radiation with and without Casodex

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medved
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   Posted 3/13/2011 7:56 PM (GMT -6)   
 
Thought some of you might be interested in this, from UroToday:
 
 
Effect of anti-androgen therapy (AAT) with bicalutamide during and after radiation therapy (RT) on freedom from progression and incidence of metastatic disease in patients following radical prostatectomy (RP) with pT2-3,N0 disease and elevated PSA levels

This study evaluated patients post radical prostatectomy with pT3N0 or pT2No and positive surgical margins and an elevated PSA. Freedom from progression and incidence of metastatic disease in these patients, following radical prostatectomy with an elevated PSA, was assessed. Patients were randomized to 150mg bicalutamide or placebo plus 64.8Gy RT. Patients were stratified by margin status, nadir PSA level, and entry PSA level. 771 patients were randomized and median age at entry was 65 years. PSA nadir after radical prostatectomy was <0.5ng/ml in 87% of patients, and PSA at entry was <1.6ng/ml in 87% of patients.

Median followup was 7.1 years and over 95% completed RT. 84% completed taking bicalutamide, compared with 95% completing oral placebo. The primary endpoint was overall survival. GU and GI toxicities were similar among the two study arms. Late gynecomastia occurred in 89% of bicalutamide treated patients. OS was 91% in the treated arm exceeding the 86% in the placebo arm. The FFP was 57% for bicalutamide vs. 40% in placebo. For Gleason scores ≤6, 7, and >8 the FFP for the bicalutamide and placebo arms were 63% vs. 50%, 55% vs. 39%, and 56% vs. 26%. This was beneficial in those with positive surgical margins and higher Gleason subtypes.

Presented by William U. Shipley, MD at the 2011 Genitourinary Cancers Symposium, General Session I: Emerging Trends in the Characterization and Treatment Decisions of Newly Diagnosed Prostate Cancer - February 17-19, 2011 - Orlando World Center Marriott, Orlando, Florida USA


zufus
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   Posted 3/14/2011 5:17 AM (GMT -6)   
Good to look at everything, these casodex patients were doing HD (high dose) 150 mg, pills are 50 mg usually so 3 a day, so they were given the maxium amount. That would lead to gynecomastia in those patients easily but that might be defeated by chest radiation protocols (light duty sometimes using electron rays, short time protocol concept) or taking another drug to offset the boob effect is another option. I did the electron rays and seemed to work fairly well and no known issues all these years later.

Medved- I was on ADT3 prior to frontline primary treatment with radiations, during radiations my rad-onco-doc said drop supplements (that I understood), but also casodex and proscar during radiations (zoladex still within me). At the time I didn't ask as to why that was necessary.
Got any ideas or guesses as to why? I could presume it might interfer with the radiation but that makes this information you posted come into another questionable light? So, just another reason to question...are there exceptions as to when and when not to use?
(see www.yananow.net)

medved
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   Posted 3/14/2011 9:30 AM (GMT -6)   

Zufus - I don't know.  The answer given from time to time on this board --do radiation in isolation so we can see to what extent the radiation is succeeding,  without conflating factors -- does not personally resonate with me, if there is evidence that the combined impact of two modalities has been shown to deliver superior results.  But I am not a doctor, and not even a very bright guy, so my views on this stuff are probably best taken with a grain of salt.

 


John T
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   Posted 3/14/2011 10:18 AM (GMT -6)   
Zufus,
The easy answer is that Rad docs are unfamiliar with HT. Casodex will shrink the prostate, but it has to be started some time before radiation as it takes about 2 months for the prostate to shrink. You also want the prostate size stable so it should be taken through out the treatment and for 3 months after treatment stops. Since the prostate will change size with Casodex I think the Rad Docs think it will affect the accurracy of the treatment and it most likely would have if not given time to stabalize.
 
Medved,
A basic principal in oncology is that combination treatments are much more effective than mono treatments. Many Chemo drugs are given in combination and combination of HT drugs such as Casodex, Lupron, Proscar and Avastin are more effective than just one drug used alone.
Most of the clinical trials involve using combinations of approved drugs at different doses and time periods to try to find the most effective combination. I agree with you that it's the combination of treatments and or drugs that contribute to the effectiveness of the treatment and that effectiveness is lost if you give treatments sequentially.
JT

F8
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Total Posts : 3780
   Posted 3/14/2011 11:04 AM (GMT -6)   
John -- my doctor started me on lupron two months before BT and IGRT.  is the study saying that adding HT to radiation is not a "gray area" cool ?
 
ed
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

compiler
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Date Joined Nov 2009
Total Posts : 7197
   Posted 3/14/2011 11:55 AM (GMT -6)   
Ed:
 
Do I detect a smirk on your face?
 
Mel

Fairwind
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Date Joined Jul 2010
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   Posted 3/14/2011 12:12 PM (GMT -6)   
"The FFP was 57% for bicalutamide vs. 40% in placebo. For Gleason scores ≤6, 7, and >8 the FFP for the bicalutamide and placebo arms were 63% vs. 50%, 55% vs. 39%, and 56% vs. 26%. This was beneficial in those with positive surgical margins and higher Gleason subtypes. "

So for high-risk G-8 patients, the ADT produced a 56% Vs 26%, who were free from progression...

No wonder my R-doc INSISTED on HT as part of his treatment plan...
Age 68.
PSA age 55: 3.5, DRE normal.
age 58: 4.5
61: 5.2
64: 7.5, DRE "Abnormal"
65: 8.5, " normal", biopsy, 12 core, negative...
66 9.0 "normal", 2ed biopsy, negative, BPH, Proscar
67 4.5 DRE "normal"
68 7.0 3rd biopsy positive, 4 out of 12, G-6,7, 9
RALP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT. 2-15-'11 PSA 0.0

John T
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   Posted 3/14/2011 12:22 PM (GMT -6)   
This is still a grey area to a lot of doctors. There are a few studies that show a benefit to HT along with radiation for biochemical reoccurrances, but even though a there is a difference in biochemical reoccurrance rates other studies have shown no benefit to overall survival.
There are other issues like psa testing that just about everyone thinks is a good idea, but have shown very little benefit to overall survival rates.
My own opinion is that anything that reduces the rate of biochemical reoccurrance is a good thing.
JT
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 3/14/2011 12:30 PM (GMT -6)   
Johns last post is very important.

The primary end point is supposed to be overall survival yet the statistical data is measuring biochemical failure. Which of course means more time is needed to show us if in fact there is a survival benefit to salvage anti-androgen therapy with Casodex.

Shipley is working with my doctor on this study. We hopefully will see that delaying biochemical failure will also improve survival.

Good post...

Tony
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
Da Vinci Surgery ~ 2/16/2007
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.
Undetectable PSA.

Blog: www.caringbridge.org/visit/tonycrispino

zufus
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Date Joined Dec 2008
Total Posts : 3149
   Posted 3/14/2011 12:39 PM (GMT -6)   
Medved- thanks for frank honest answer

John- I did ADT3 for 5 months prior to radiations, which my rad-doc knew all about and this guy is not the average rad doc (if you know what I'm sayin' how many docs actually know how to use neutron rays/cyclotron & photon/IMRT and do dosmetrics and calculations on all that...also without killing the patient-LOL), I did continue ADT3 after radiation and he was fine with that, and as per back then Bolla studies showed definite improved survival percentages.
 
This particular rad-doc told me about DES, casodex and proscar things back in 2002, he teachs at Wayne State Med. University, and has written articles found in PubMed or similar on hormone therapies (although I didn't get access to read them). He does most of the mets radiations in the Michigan area, it seems...considered an expert by many and found in one of the prostate cancer books as the poster child of a rad-doc. Anyway- maybe has to do with shrinkage being able to maybe continue even after 4 months or so (I didn't get casodex at first, uro-doc was in errror on the flare thing, strike one).  So maybe John your idea about it shrinking or moving is the reason.

There are lots of ways to treat PCa, some seem outside of mainstream, but have results that could be huge....i.e. Dr. Fred Lee's own PCa story....amazing if you missed it before.

Anyway super glad I did ADT3 per Bolla abstract and did the particular radiations I did, my stats were high....I doubt I would be alive if I didn't do some of things I have done. I was at my onco-docs office visit today and asked where do you think I would be if I did 9 yrs. of Lupron...he mentioned dead. Based upon my stats and original total urinary blockage from PCa....I think that statment could have been all to real. I know this can be challenged , I see plenty in PCa issues. I can just imagine my bones and memory and body if I was using 9 yrs. of Lupron or ADT3, which my uro-doc had planned for me, but got fired in year two. (LOL)  Thanks for the replies.

Post Edited (zufus) : 3/14/2011 12:47:08 PM (GMT-6)


F8
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Date Joined Feb 2010
Total Posts : 3780
   Posted 3/14/2011 4:23 PM (GMT -6)   
mel -- yes cool .
 
John T  -- i agree.  i also think that when you've got a chance for a "cure" you go for it.  i don't understand statistics but i know they can be misleading.  it seems to me that anything that knocks back or stops the cancer is going to make you live longer, and that's my goal.
 
ed
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25364
   Posted 3/14/2011 4:34 PM (GMT -6)   
Ed, I respectively agree and disagree at the same time. If someone said, I have PC and I insist on having surgery, adjunct RT, and HT all as close together as possible - because I want to throw everything at it, we would probably think the guy was nuts.

Still too many conflicting reports and opinions at the pro level about adding or not adding HT in the mix. If a person had surgery, until it has proven to fail, then why subject the body to that unless its needed. And if you need SRT, i.e., then why add the side effects of HT unless the radiation has proven to fail. There are good doctors that agree with this logic, and good doctors that don't.

David
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 2/11 1.24
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/10,

F8
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Date Joined Feb 2010
Total Posts : 3780
   Posted 3/14/2011 6:00 PM (GMT -6)   
>>Still too many conflicting reports and opinions at the pro level about adding or not adding HT in the mix.<<
 
there's no conflict at my doctor's office. never one bit.  my doctor told me i'd have a 60% chance of needing SRT and he said with that in mind he didn't think surgery was a good choice for me.  also, because i had a high volume of cancer he recommended a combination treatment -- HT, BT and IGRT.  also my prostate is very small, making me a VG candidate for seeds.
 
now with all due respect your doctor's may think differently and there may indeed be a gray area but there was never any doubt or conflict with any of my doctor's regarding what was best for me. none whatsoever. 
 
i should add that my doctor believes that HT is overused and at first he recommended six months of lupron, which because of the way scheduling fell turned into nine months.  my radiation oncologists  -- there are three  of them -- all agreed that short-term-HT would be beneficial to me.
 
and i'm one to err on the side of "overtreatment".
 
of course we don't know if the treatment worked but i should have a better idea before the end of the year.
 
ed
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

Post Edited (F8) : 3/14/2011 6:03:16 PM (GMT-6)


F8
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Date Joined Feb 2010
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   Posted 3/14/2011 6:08 PM (GMT -6)   
>>And if you need SRT, i.e., then why add the side effects of HT unless the radiation has proven to fail. There are good doctors that agree with this logic, and good doctors that don't.<<
 
David -- one more thing, HT just isn't the monster you make it out to be, and between the two of us i know. sometimes you act like some of us wanted HT; that we were gungho to be bloated, sweaty and emasculated.
 
i want to live and if that means a short-term hit to my QOL so be it.  i'm down for it.  bring it on cool !
 
ed
 

 
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25364
   Posted 3/14/2011 6:23 PM (GMT -6)   
Ed, I don't doubt the wisdoms of your doctors, or their advice to you. Wouldn't pressume to do that to you or anyone else.

I can't imagine, if you were being literal, that anyone was gunning to be on HT, lol. I don't really think its a monster, and for some guys here, its not that bad of a ride for them. You could say the same for SRT, for many - just a couple of months of treatments and a short bout of side effects, for me, it was a living hell and I am still paying the price and it didn't work.

Looks like we are about 3 years apart. I don't any kind of death wish in particular. Just 3 years ago, I was still riding a motorcycle at speeds to 155 mph on narrow windy roads here, probably had a higher level of pending death from that habit than PC has been for me so far.

David
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 2/11 1.24
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/10,

John T
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Date Joined Nov 2008
Total Posts : 4188
   Posted 3/14/2011 6:25 PM (GMT -6)   
Tony,
I'll go way out on a limb. I think that the issue with not many treatments increasing the overall survival of prostate cancer patients is mainly due to the statistics of large numbers. Most prostate cancer patients are older, in thier 60's and 70's and have a life expectancy of about 10 to 15 years. At this point other causes of death due to just getting old start to take affect. The number of younger patients that do have a survival benefit are not enough to sku the statistics of a lot of older men that will die from something else. Even after biochemical reoccurrance many patients can last 15 years and this greatly increases their chances of dieing from something else.
This is just my opinion and have no evidence to back it up. It just bothers me that with all the psa testing and all the treatments over the last 10 or 15 years the death rate from PC is still 4%.
JT
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Purgatory
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Date Joined Oct 2008
Total Posts : 25364
   Posted 3/14/2011 6:33 PM (GMT -6)   
John, just thinking about the "stats" side of your post. Could the 4% death rate still be more, in that many more men are being diagnosed do to PSA testing than in the past. More diagnosed, more cases, more reported deaths? No facts to back this.
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 2/11 1.24
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/10,

F8
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Date Joined Feb 2010
Total Posts : 3780
   Posted 3/14/2011 6:42 PM (GMT -6)   
John -- i think you are on to something.  treatment has progressed quite a bit in the last 10 years which may not be fully reflected in the numbers. another reason we chose aggressive treatment is i'm relatively young and healthy with potentially another 30 years of life left.
 
ed
 
 
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

John T
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Date Joined Nov 2008
Total Posts : 4188
   Posted 3/14/2011 8:54 PM (GMT -6)   
Ed,
I think that PC falls into three catagories.
1. Non agressive PC that will never hurt you in your lifetime.
2. Very agressive PC that regardless of treatment will cause death in a short number of years. (Think varients or G9 or 10)
3. Intermediate PC that if caught in time treatment can prolong life for many years.
If 50% -60%of all DXed pc is in the 1st catagory and 5-10% is in the 2nd catagory then we can only affect overall survival in 30% -45% of the patients. We know that approximately 30% of intermediate risk patients fail primary treatment. Therefore 21% -31% benefit from treatment. Unfortunately we can't tell which individual patients will benefit and which will not with any degree of certainty. If we want to move the end number we can only influence the 30% of intermediate risk patients that fail primary treatment. We can prolong the life of high risk patients and those that fail primary treatment, but we can't affect the end number of deaths from PC to any great extent with the treatments we have today.
This is why I think that the 4% hasn't changed much over the years regardless of psa testing and all treatments we have.
JT
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Fairwind
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Date Joined Jul 2010
Total Posts : 3632
   Posted 3/14/2011 9:46 PM (GMT -6)   
"2. Very aggressive PC that regardless of treatment will cause death in a short number of years. (Think varients or G9 or 10)"

Come on John, if caught soon enough, us G-9 guys do surprisingly well..We don't get the pass G-6 guys do, but it's not hopeless.. Most of the 32,000 a year who are terminal had PSA's over 50 when first diagnosed....The cat was WAY out of the bag...

F8
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Date Joined Feb 2010
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   Posted 3/14/2011 11:34 PM (GMT -6)   
>>>3. Intermediate PC that if caught in time treatment can prolong life for many years.<<<
 
John,  are you saying that we'll die of cancer anyway? i think that remains to be seen in cases that have been treated aggressively with modern treatment. 
 
ed
age: 55
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

Carlos
Regular Member


Date Joined Nov 2009
Total Posts : 486
   Posted 3/15/2011 9:41 AM (GMT -6)   

Ed, I don’t believe there is any gray area about the benefit of adding HT to primary radiation.   The study medved  posted was simply trying to determine if those same benefits would carry over to SRT for those of us that failed surgery.  The results aren’t encouraging with regard to the overall survival benefit.   The above study is one of five ongoing Phase III clinical trials trying to answer that question.

 

Carlos


Dx 2/2008, age 71, PSA 9.1, G8,T1c. daVinci surgery 5/2008, G8(5+3), pT2c. LFPF, good QOL. PSA <0.1 for 2 yrs. PSA rose to .2 at 30 months, Completed SRT 2/2011. PSA 0.1 at 3 wks post SRT.

John T
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Date Joined Nov 2008
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   Posted 3/15/2011 11:34 AM (GMT -6)   
Ed and Fairwind.
Prostate cancer is a spectrum that goes from indolant to extremently agressive. The D''Amico risk classifications are just lines drawn at places along that spectrum. Of course there are high risk patients that will survive; we cannot determine an individual's outcome, but we can make generalizations about risk catagories. As a group 70% of intermediate risk cases will be cured and 30% will suffer reoccurrances. The number of high risk cases caught early that are cured is about 45%.
There are a number of high risk cases at the far end of the spectrum that will not be cured regardless of treatment and time of DX. Age is a very important factor as many of those with high risk PC will die of something else simply because they are reaching that point in thier lives. If people didn't die from other causes and lived to be 100 then we would have many more prostate cancer deaths. The low and stable death rate from PC is due more from patients reaching old age and dieing from something else. The 10 years survival rate is close to 100% ,so the chances of a patient dxed in his 60's or 70's dieing from something else is very high.
What I was attempting to do was to give an explaination of why I think the rate of deaths from PC has remained stable at 4% for the last 20 years in spite of all the advancements in testing and treatments. I think that this is an important question. We can't affect the death rate by treating the highest number of PC patients, those in the low risk catagory, because they don't die. The majority of high risk patients fail treatment so we can prolong life, but not cure.
As Tony mentioned the end point is overall survival. As many studies point out that the treaments seem successful, but overall survival never goes up, Why???
I'm just "blue skying" here trying to think out of the box. If one of my companies kept adding expensive equipment and increasing their research or marketing budgets without increasing profits I would be all over the managers to justify what they were doing or trying to find out what wasn't working and why.
JT
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Fairwind
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Date Joined Jul 2010
Total Posts : 3632
   Posted 3/15/2011 12:56 PM (GMT -6)   
Just a slight correction...The overall death-rate from Prostate cancer is 15%, not 4%

220,000 are diagnosed every year and 32,000 die every year...

JNF
Veteran Member


Date Joined Dec 2010
Total Posts : 3656
   Posted 3/15/2011 2:03 PM (GMT -6)   
Does the 4% relate to the number of deaths divided by the number that have PCa? If 32,000 die this year from PCa, at a 4% death rate it means some 800,000 have PCa. With 220,000 new cases a year I don't think this is correct. There should be probably twice that many of us with PCa.

Fairwind, your calculation is the total number of deaths in a year divided by the number newly diagnosed that year, which is not the overall death rate.

From all causes some 2,500,000 males die each year in America. 4% of that figure would be 100,000 deaths. So it is not this number either.

John T, how is the 4% death rate determined?
PSA 59 on 8-26-2010 age 60. Biopsy 9-8-2010 12/12 positive, 20-80% involved, PNI in 3 cores, G 3+3,3+4,and 4+3=G7, T2b.
Eligard shot and daily Jalyn started on 10-7-2010.
IMRT to prostate and lymph nodes 25 fractions started on 11-8-2010, HDR Brachytherapy 12-6 and 13-2010.
PSA <.1 and T 23 on 2-3-2011.
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