ProtecT is published...Watch Urologists Squirm and Make excuses

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Neuronix said:
The immediate response will be: in the UK they don't use the robot therefore the surgical side effect outcomes aren't as good as they are in the US.
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Of course it will be...but will anyone followup with the RCT that shows no difference between robot and open? I look forward to the TV urologists disparaging their British colleagues as incompetent
 
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It suggests both treatments are similar and superior to observation. Not sure how surgery really "loses" is all this.

The urologists will still see the patient first and tell them (behind closed doors) that surgery is better. We can say anything we want in tumor board and the urologist will just say "the patient wants surgery"
 
The greatest gain in my personal opinion is the publication of the toxicity data. We have had data in the past from comparative registries, but never from a randomized trial. And yes, I think that bloody stools (which can be treated quite well with endoscopic procedures and medication) are far less of an issue than wearing pads for the rest of your life...
http://www.nejm.org/doi/full/10.1056/NEJMoa074311#t=article
 
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thesauce said:
It suggests both treatments are similar and superior to observation. Not sure how surgery really "loses" is all this.

The urologists will still see the patient first and tell them (behind closed doors) that surgery is better. We can say anything we want in tumor board and the urologist will just say "the patient wants surgery"
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As palex alluded to, the patient reported data is where surgery loses. I agree though that Urologists are in the driver's seat when it comes to prostate cancer management. The only thing that helps that are educated patients and PCPs
 
Neuronix said:
As long as urology does the endorectal ultrasounds and performs the biopsies, they will control the patients.
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Yup. It's the only cancer I know of that way. Most PCPs send their breast masses to radiology for mammogram and stereotactic biopsy before they see a surgeon. Lung masses can be sent to IR or pulmonary for biopsy by a PCP before they see a surgeon.
 
medgator said:
Yup. It's the only cancer I know of that way. Most PCPs send their breast masses to radiology for mammogram and stereotactic biopsy before they see a surgeon. Lung masses can be sent to IR or pulmonary for biopsy by a PCP before they see a surgeon.
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Any chance at all that IR could take over biopsy if MRI guidance takes off?


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I too think it's a very well done trial.

I hate to be a nihilist, but even with great data I don't think this changes much as far as prostate cancer management in my region. As mentioned, as long as urologists control the flow of patients, do the biopsies, and don't want true multi-disciplinary clinics, then it's business as usual. I may have more good quality of data to show patients side effect profiles, but we already had pretty good data/QOL studies that are similar to this. With low risk prostate cancer you can barely find a difference (if any at all) between observation and treatment, so you're not likely to see any earth shattering XRT or surgery is clearly better data.

For me at least, until the urologists at my cancer center agree that the vast majority of patients should see a rad onc before they decide about treatment modality, little will change - a lot of "I talked with him about radiation, but he wanted surgery, thanks anyway, you don't need to see him...."
 
damico said this in his editorial; can someone explain further? thanks:

"Finally, a trend favoring radiation and short-course androgen-deprivation therapy over surgery was observed. Specifically, the point estimate for the hazard ratio for death from prostate cancer when comparing these two treatments was 0.80 (95% CI, 0.22 to 2.99). If this trend becomes significant, then one may consider radiation and androgen-deprivation therapy as a preferred option for otherwise healthy men 65 years of age or older with early prostate cancer for whom treatment as compared with monitoring may be more effective (P=0.09 for interaction) in reducing death from prostate cancer."
 
Haybrant said:
damico said this in his editorial; can someone explain further? thanks:

"Finally, a trend favoring radiation and short-course androgen-deprivation therapy over surgery was observed. Specifically, the point estimate for the hazard ratio for death from prostate cancer when comparing these two treatments was 0.80 (95% CI, 0.22 to 2.99). If this trend becomes significant, then one may consider radiation and androgen-deprivation therapy as a preferred option for otherwise healthy men 65 years of age or older with early prostate cancer for whom treatment as compared with monitoring may be more effective (P=0.09 for interaction) in reducing death from prostate cancer."
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Think he's saying that the HR favoring RT and SC-ADT is something to keep an eye on. However, given that the 95% CI is 0.22 to 2.99 (and hazard ratios are only useful with the 95% CI is either all below 1 or all above 1), I think it's unlikely that the top end of the CI will drop below 1 to show a significant benefit favoring RT + SC-ADT.
 
Haybrant said:
damico said this in his editorial; can someone explain further? thanks:

"Finally, a trend favoring radiation and short-course androgen-deprivation therapy over surgery was observed. Specifically, the point estimate for the hazard ratio for death from prostate cancer when comparing these two treatments was 0.80 (95% CI, 0.22 to 2.99). If this trend becomes significant, then one may consider radiation and androgen-deprivation therapy as a preferred option for otherwise healthy men 65 years of age or older with early prostate cancer for whom treatment as compared with monitoring may be more effective (P=0.09 for interaction) in reducing death from prostate cancer."
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I think Anthony is overreaching. There were 17 deaths attributable to prostate cancer in this study-woefully underpowered to draw meaningful inference at this point. The interaction with age (Table 2 in the original paper) was referenced in the preceding paragraph of his editorial and should be considered hypothesis generating. Interaction means that the treatment effect differs according to a baseline variable (in this case age above or below 65). To repeat this is hypothesis generating and this effect was not observed in the SPCG-4 study of surgery versus watchful waiting (with many more events- 66 deaths attributable to prostate cancer in the surgery arm and 99 in the watchful waiting arm) . The mention of the HR for the comparison between surgery and radiation is a big surprise. To repeat, in total there were 17 deaths attributed to prostate cancer for the whole study-5 in the surgery arm and 4 in the radiation arm. To call this a trend is really a stretch (yes 4 is less than 5 but..). A simple glance at the 95% CI for the HR of 0.22-2.99 makes this very clear.
 
Won't change anything. Prostate cancer referrals are all about the $$$. This is the benefit of the urorads model--actually directs patients towards the better treatment!
 
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The urologists that we had been working closely with for years got a robot about 6 months ago. Prior to that, they sent us 4 patients per month. We haven't seen a single referral from them for 6 months now.
 
thesauce said:
The urologists that we had been working closely with for years got a robot about 6 months ago. Prior to that, they sent us 4 patients per month. We haven't seen a single referral from them for 6 months now.
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Doesn't make sense to me unless they are hospital-employed?

Robots don't make more money for the urologists than a regular RP afaik, I think it helps the hospital that owns the robot more
 
The best part of the article is the exposure of RT - can't tell you how many news outlets picked up the story and how little the average person knows about RT. A few of them even picked up on the toxicity differences, though most of them just said 'don't treat'... which may not be the complete take home conclusion.

The graph for sexual function is pretty substantial - outside the ADT sexual function is almost as good as observation after RT. Think about that. That is now proven in a fairly large cohort followed prospectively with modern techniques.

Urology as a field is always going to display a certain intellectual dishonesty when it comes to prostate cancer. Without the exclusive management of this, then urology as a field needs probably ~50% of the work force it currently has, and it can't attract those 'I like surgery but not real big surgery' type people (which is not a putdown, I don't like either surgery) with a primarily office and procedure only practice. I mean how many urologists does this country need for nephrectomies, cystectomies, penile implants, ochiectomies, pelvic floor issues, etc. And much as we see in our own field, professional societies care little about anything more than increasing their numbers and having cheap, captive labor.

In so much as this highlights the effectiveness of radiation, was picked up by popular culture, and provides contemporary prospective data that erectile function after RT is excellent, this was a good validation of what most of us knew and a huge win. I doubt it will translate into better treatment of prostate cancer, which should be less RPs. I know 8 weeks of radiation isn't right for everyone, but neither is losing your ability to have intercourse. If you already have ED, then pick between a higher risk of incontinence versus a lower risk of bloody stools.
 
DebtRising said:
though most of them just said 'don't treat'... which may not be the complete take home conclusion.
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This is what got pushed to my phone.

http://www.nytimes.com/aponline/2016/09/14/health/ap-eu-med-prostate-cancer.html?_r=0

This totally glosses over the facts that over 50% of active surveillance patients, most of whom were low risk, ended up being treated over 10 years. The incidence of metastatic disease more than doubled for active surveillance (albeit the numbers are small overall: 6.3% vs. 2.4% or 3.0%, p=0.004). A total of 9 men would need to be treated with either prostatectomy or radiotherapy to avoid 1 patient having clinical progression. That seems pretty significant to me. Further, since this is prostate, we'll probably need another 10 years to see a survival difference--though I think it's unlikely we ever will with the # of metastatic progressions and this being low risk disease.

This comes back to the old question--is it worth treating to prevent disease progression or improve QOL? I think so. I think this push towards "if it doesn't improve survival it isn't worth it" is bleeding over from some other specialties where cost is an ever increasing issue, but I'm not in favor of it in a lot of radiation situations. If we have to show survival benefit to every scenario in which we radiate, a lot of patients will suffer because we won't be radiating a lot of things we do now.

The only thing I wish had been done differently from a radiation perspective is that all patients got 5-8 months of ADT (3-6 neoadjuvant + concurrent). My training always tried to avoid ADT due to QOL issues. ADT seems overkill for low risk, though maybe that helps for 74 Gy 3D-Conformal? Are outcomes equivalent with 78 Gy IMRT so that ADT is not necessary or was the ADT never necessary? I would think so.
 
Neuronix said:
This is what got pushed to my phone.

http://www.nytimes.com/aponline/2016/09/14/health/ap-eu-med-prostate-cancer.html?_r=0

This totally glosses over the facts that over 50% of active surveillance patients, most of whom were low risk, ended up being treated over 10 years. The incidence of metastatic disease more than doubled for active surveillance (albeit the numbers are small overall: 6.3% vs. 2.4% or 3.0%, p=0.004). A total of 9 men would need to be treated with either prostatectomy or radiotherapy to avoid 1 patient having clinical progression. That seems pretty significant to me. Further, since this is prostate, we'll probably need another 10 years to see a survival difference--though I think it's unlikely we ever will with the # of metastatic progressions and this being low risk disease.

This comes back to the old question--is it worth treating to prevent disease progression or improve QOL? I think so. I think this push towards "if it doesn't improve survival it isn't worth it" is bleeding over from some other specialties where cost is an ever increasing issue, but I'm not in favor of it in a lot of radiation situations. If we have to show survival benefit to every scenario in which we radiate, a lot of patients will suffer because we won't be radiating a lot of things we do now.

The only thing I wish had been done differently from a radiation perspective is that all patients got 5-8 months of ADT (3-6 neoadjuvant + concurrent). My training always tried to avoid ADT due to QOL issues. ADT seems overkill for low risk, though maybe that helps for 74 Gy 3D-Conformal? Are outcomes equivalent with 78 Gy IMRT so that ADT is not necessary or was the ADT never necessary? I would think so.
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4-6 months of ADT added to 65-70 Gy XRT has been demonstrated to improve survival-no such benefit has been evident for an additional 4-9 Gy added to 68-7o Gy.

The Europeans (UK in particular) use short courses routinely, US not so much. In 10 years RTOG 0815 will provide an answer whether 6 months of ADT adds anything to lots of radiation.
 
Neuronix said:
This is what got pushed to my phone.

http://www.nytimes.com/aponline/2016/09/14/health/ap-eu-med-prostate-cancer.html?_r=0

This totally glosses over the facts that over 50% of active surveillance patients, most of whom were low risk, ended up being treated over 10 years. The incidence of metastatic disease more than doubled for active surveillance (albeit the numbers are small overall: 6.3% vs. 2.4% or 3.0%, p=0.004). A total of 9 men would need to be treated with either prostatectomy or radiotherapy to avoid 1 patient having clinical progression. That seems pretty significant to me. Further, since this is prostate, we'll probably need another 10 years to see a survival difference--though I think it's unlikely we ever will with the # of metastatic progressions and this being low risk disease.

This comes back to the old question--is it worth treating to prevent disease progression or improve QOL? I think so. I think this push towards "if it doesn't improve survival it isn't worth it" is bleeding over from some other specialties where cost is an ever increasing issue, but I'm not in favor of it in a lot of radiation situations. If we have to show survival benefit to every scenario in which we radiate, a lot of patients will suffer because we won't be radiating a lot of things we do now.

The only thing I wish had been done differently from a radiation perspective is that all patients got 5-8 months of ADT (3-6 neoadjuvant + concurrent). My training always tried to avoid ADT due to QOL issues. ADT seems overkill for low risk, though maybe that helps for 74 Gy 3D-Conformal? Are outcomes equivalent with 78 Gy IMRT so that ADT is not necessary or was the ADT never necessary? I would think so.
Click to expand...
I think adding adt made the trial more relevant at those xrt doses. Agree with you that overall survival isn't the only issue here, having metastatic disease and lifelong lupron isn't a great way to live
 
Neuronix said:
This is what got pushed to my phone.

http://www.nytimes.com/aponline/2016/09/14/health/ap-eu-med-prostate-cancer.html?_r=0

This totally glosses over the facts that over 50% of active surveillance patients, most of whom were low risk, ended up being treated over 10 years. The incidence of metastatic disease more than doubled for active surveillance (albeit the numbers are small overall: 6.3% vs. 2.4% or 3.0%, p=0.004). A total of 9 men would need to be treated with either prostatectomy or radiotherapy to avoid 1 patient having clinical progression. That seems pretty significant to me. Further, since this is prostate, we'll probably need another 10 years to see a survival difference--though I think it's unlikely we ever will with the # of metastatic progressions and this being low risk disease.

This comes back to the old question--is it worth treating to prevent disease progression or improve QOL? I think so. I think this push towards "if it doesn't improve survival it isn't worth it" is bleeding over from some other specialties where cost is an ever increasing issue, but I'm not in favor of it in a lot of radiation situations. If we have to show survival benefit to every scenario in which we radiate, a lot of patients will suffer because we won't be radiating a lot of things we do now.

The only thing I wish had been done differently from a radiation perspective is that all patients got 5-8 months of ADT (3-6 neoadjuvant + concurrent). My training always tried to avoid ADT due to QOL issues. ADT seems overkill for low risk, though maybe that helps for 74 Gy 3D-Conformal? Are outcomes equivalent with 78 Gy IMRT so that ADT is not necessary or was the ADT never necessary? I would think so.
Click to expand...
I think we should begin to emphasize prevention of metastatic disease. It is a state with significant negative QOL effects and once documented begins an incredibly expensive treatment course. A couple of months of the newer agents cost many times what XRT does in any scenario
 
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Chartreuse Wombat said:
I think we should begin to emphasize prevention of metastatic disease. It is a state with significant negative QOL effects and once documented begins an incredibly expensive treatment course. A couple of months of the newer agents cost many times what XRT does in any scenario
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Its been my main go to whenever I speak to a healthy patient. I tell them that a lot of the studies focus on overall survival but that is really not the appropriate endpoint to think about. The quality of life after developing mets however is significantly worse (adt, chemo, frequent hospital visits, scans etc)
 
Haybrant said:
Its been my main go to whenever I speak to a healthy patient. I tell them that a lot of the studies focus on overall survival but that is really not the appropriate endpoint to think about. The quality of life after developing mets however is significantly worse (adt, chemo, frequent hospital visits, scans etc)
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Pain, cord compression, pathologic fx in some cases...
 
Per the v3.2016 NCCN Prostate Guideline:

"Life expectancy estimation is critical to informed decision making in prostate cancer early detection and treatment. Estimation of life expectancy is possible for groups of men but challenging for individuals."

Individual are doing it wrong; we need groups of male physicians to estimate life expectancies. I remain uncertain how mixed gender or purely female groups do re: estimating life expectancy.
 
I was looking at the supplementary tables (http://www.nejm.org/doi/suppl/10.1056/NEJMoa1606220/suppl_file/nejmoa1606220_appendix.pdf). I noticed that among the prostate cancer deaths (table s4) that of the 5 prostate cancer deaths in the RP arm only 2 actually had an RP! Same for the 4 prostate cancer deaths in the RT arm.

So by treatment received the prostate cancer deaths is: 13 (AS), 2 (RP), 2 (RT). I don't know if this would be statistically significant but it certainly makes the hazard ratios more impressive.

I understand that intent to treat is the standard way to evaluate a trial but when the difference between intent to treat and treatment received is this large I think it should be more clearly discussed in the paper.
 
hot sauce said:
I was looking at the supplementary tables (http://www.nejm.org/doi/suppl/10.1056/NEJMoa1606220/suppl_file/nejmoa1606220_appendix.pdf). I noticed that among the prostate cancer deaths (table s4) that of the 5 prostate cancer deaths in the RP arm only 2 actually had an RP! Same for the 4 prostate cancer deaths in the RT arm.

So by treatment received the prostate cancer deaths is: 13 (AS), 2 (RP), 2 (RT). I don't know if this would be statistically significant but it certainly makes the hazard ratios more impressive.

I understand that intent to treat is the standard way to evaluate a trial but when the difference between intent to treat and treatment received is this large I think it should be more clearly discussed in the paper.
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In real life patients end up not getting the intended course of treatment. also if you exclude people who didn't get the intervention then you've broken the randomization.


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Krukenberg said:
In real life patients end up not getting the intended course of treatment. also if you exclude people who didn't get the intervention then you've broken the randomization.


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I understand why intent to treat analysis is the standard and I'm not suggesting that it should not be reported. However, I think it bears mentioning when 50% or more of the patients who had the event that is the primary outcome did not get the assigned treatment. It is not unreasonable to also report per protocol analysis (in addition to not instead of ITT) when there is a large difference between the two groups.
 
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