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ASTRO and AUA issue joint guideline for radiation therapy after prostatectomy

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Posted 5/8/2013 1:51 PM (GMT 0)

This talks about a joint guideline on radiation therapy after prostatectomy for patients with and without evidence of prostate cancer recurrences.  It is a comprehensive review of 324 research articles of English-language publications within the Pubmed, Embase and Cochrane databases, published from January 1, 1990 through December 15, 2012. The guideline is available online free as a PDF document at www.redjournal.org and www.auanet.org, and will be published in the August 1, 2013.

Here is a direct link to the full pdf:  https://www.astro.org/uploadedFiles/Main_Site/News_and_Media/News_Releases/2013/ASTRO-AUA%20RT%20After%20Prostatectomy%20Guideline%20PR_FINAL%20050313.pdf

As part of this summary the guideline lists (9) clinical principles, recommendations, standards and options; while all are valuable information and data, I felt #5 would be helpful for those trying to understand criteria for biochemical recurrence after prostatectomy, as I know that's been discussed out here a number of times:

"5) clinicians should define biochemical recurrence as a detectable or rising PSA value after surgery that is ≥ 0.2 ng/ml with a second confirmatory level ≥ 0.2 ng/ml."

Anyhow I thought this was interesting stuff and thought I would start a thread on it.

Posted 5/8/2013 7:27 PM (GMT 0)
I've been reading it this AM and have more to read, but what strikes me most is the new standard of care:

Guideline #3 said...
"Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy including seminal vesicle invasion, positive surgical margins, or extraprostatic extension because of demonstrated reductions in biochemical recurrence, local recurrence, and clinical progression. (Standard; Evidence Strength: Grade A)"

This is just recognizing the strength of the recent evidence on the superior cure rates when radiation is given before the PSA has a chance to rise to a level where it is officially labeled a "recurrence.". When they use the term "offer," they are referring to a process of risk/benefit discussion and decision sharing.

Most of the rest seems to be about keeping the patient informed about risks and benefits from before the prostatectomy decision, and afterwards, if there are adverse findings.
Posted 5/8/2013 7:33 PM (GMT 0)
I am happy to see this one. I was getting ready to post it but glad Yooper got it out there.

I fell into the right category for guideline 3...

Tony
Posted 5/8/2013 10:26 PM (GMT 0)
Tall Allen (or anyone else):

What recent evidence showing better cure rates if radiation given before 'recurrence' are you referring to?

I'm having to decide right now between adjuvant radiation and monitoring my PSA with possible salvage.

I have yet to get a good idea of the difference between if I go for adjuvant as soon as possible vs monitoring my PSA, and if it rises then I go while it's still quite low (say .1 or .2)?

This study seems to look at adjuvant vs no radiation followup, and around page 20 they seem to say the jury is still out on adjuvant vs early salvage.

ANY info anyone has on this would be very helpful.
Posted 5/9/2013 12:54 AM (GMT 0)
Aachen,

There were 3 recent long-term randomized clinical trials that I've seen on this issue. The German ARO-96-02 study randomized 385 men to ART or waiting and tracked them for about 10 years. At 10 years median follow up, ART reduced the risk of "biochemical No Evidence of Disease" (bNED) by 49% relative to waiting.

Phase III results of adjuvant radiotherapy (RT) versus wait-and-see (WS) in patients with pT3 prostate cancer following radical prostatectomy (RP)(ARO 96-02/AUO AP 09/95): Ten years follow-up.

The French EORTC trial randomly assigned 1005 patients to ART or waiting and followed them for up to 16.6 years. they found that Results at median follow-up of 10·6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait-and-see policy. They found that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins, but could have a detrimental effect in patients aged 70 years or older.

Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911).

Finally, the SWOG Study on 425 men randomized to ART within 18 weeks vs observation and followed for a median of 12.5 years found a reduced risk of PSA recurrence, metastasis and the need for hormonal therapy, and significantly increases survival.

Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival:Long-Term Followup of a Randomized Clinical Trial

Dr. King determined that treatment should begin before PSA reaches .2 (recurrence) and with at least 70 Gy:
The timing of salvage radiotherapy after radical prostatectomy: a systematic review.
Posted 5/9/2013 12:58 AM (GMT 0)
Tall:

Thank you.

But what I'm not seeing is what 'wait and see' really means.

Does that mean they compare adjuvant to all men that 'wait and see' was the chosen option, including those that either never got salvage or waiting until they had very high PSA?
Posted 5/9/2013 1:03 AM (GMT 0)
And what about Prolaris http://www.prolaristest.com/information-for-physicians/prolaris/?

Seems to me I'd be an ideal candidate for this.

But not a one of the four oncologists I've seen or the radiologists either have even mentioned this.
Posted 5/9/2013 1:09 AM (GMT 0)
Or the new Oncotype DX test?

Seems to me it's the same as Polaris, but brand new.

http://www.nytimes.com/2013/05/08/business/prostate-cancer-test-from-genomic-health-assesses-risks.html
Posted 5/9/2013 2:23 AM (GMT 0)
"Wait and see" in those studies meant to wait until the PSA rose to recurrence level (.2) - in other words, salvage RT.
Posted 5/9/2013 2:40 AM (GMT 0)
Thanks for this thread. My husband will need to make same decisions. He had a positive margin. Hate decisions:)
Posted 5/9/2013 3:50 AM (GMT 0)
Thank you. This is very helpful.
Posted 8/7/2013 11:12 PM (GMT 0)
I wanted to bump up this thread because the full guidelines were just officially published.

It's available here:


ADJUVANT AND SALVAGE RADIOTHERAPY AFTER PROSTATECTOMY: ASTRO/AUA GUIDELINE

The Guideline Statements said...
Guideline Statement 1. Patients who are being considered for management of localized prostate cancer with radical prostatectomy should be informed of the potential for adverse pathologic findings that portend a higher risk of cancer recurrence and that these findings may suggest a potential benefit of additional therapy after surgery. (Clinical Principle)

Guideline Statement 2. Patients with adverse pathologic findings including seminal vesicle invasion, positive surgical margins, and extraprostatic extension should be informed that adjuvant radiotherapy, compared to radical prostatectomy only, reduces the risk of biochemical (PSA) recurrence, local recurrence, and clinical progression of cancer. They should also be informed that the impact of adjuvant radiotherapy on subsequent metastases and overall survival is less clear; one of two randomized controlled trials that addressed these outcomes indicated a benefit but the other trial did not demonstrate a benefit. However, the other trial was not powered to test the benefit regarding metastases and overall survival. (Clinical Principle)

Guideline Statement 3. Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy including seminal vesicle invasion, positive surgical margins, or extraprostatic extension because of demonstrated reductions in biochemical recurrence, local recurrence, and clinical progression. (Standard; Evidence Strength: Grade A)

Guideline Statement 4. Patients should be informed that the development of a PSA recurrence after surgery is associated with a higher risk of development of metastatic prostate cancer or death from the disease. Congruent with this clinical principle, physicians should regularly monitor PSA after radical prostatectomy to enable early administration of salvage therapies if appropriate. (Clinical Principle)

Guideline Statement 5. Clinicians should define biochemical recurrence as a detectable or rising PSA value after surgery that is ≥ 0.2 ng/ml with a second confirmatory level ≥ 0.2 ng/ml. (Recommendation; Evidence Strength: Grade C)

Guideline Statement 6. A restaging evaluation in the patient with a PSA recurrence may be considered. (Option; Evidence Strength: Grade C)

Guideline Statement 7. Physicians should offer salvage radiotherapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease. (Recommendation; Evidence Strength: Grade C)

Guideline Statement 8. Patients should be informed that the effectiveness of radiotherapy for PSA recurrence is greatest when given at lower levels of PSA. (Clinical Principle)

Guideline Statement 9. Patients should be informed of the possible short-term and long-term urinary, bowel, and sexual side effects of radiotherapy as well as of the potential benefits of controlling disease recurrence. (Clinical Principle)

Posted 9/12/2013 11:51 AM (GMT 0)
Tall Allen:

Thank you.

But worth noting that these shouldn't be universally accepted as gospel in all cases.

My radiation oncologist touted these as GOSPEL when they came out and insisted I have immediate radiation.

It was only when I went to Dana Farber in Boston and spoke with Dr. D'Amico did I realize that my low Gleason score was an important consideration.

D'Amico's studies show that I have a less than 20 percent chance of cancer return, and if so that salvage surgery AS LONG AS I MONITOR MY PSA is just as effective as adjuvant.

Nowhere in these guidelines do they account for patients like me.

I feel like some oncologists are using these guidelines as a marketing tool.
Posted 9/12/2013 3:22 PM (GMT 0)
Aachen,

From your numbers it looks like you may have had the kind of PCa often classified as insignificant. Hopefully it is indolent as well. Certainly you would have been a good candidate for AS by anyone's AS criteria. Since a true Gleason 6 is not known to metastasize beyond the local area, I could certainly see how taking an AS stance at this point may make sense, especially considering your undetectable PSA. D'Amico is the king of risk stratification. How does he classify your pGS 3+3+4? Does he consider it to be of intermediate risk of recurrence, or low risk?
Posted 9/12/2013 3:32 PM (GMT 0)
Yeah,

(I made a long response to "robot"s posting this morning.  It may interest those who have positive margins.)

These guidelines prompted me to discuss this issue with my surgeon/uro last follow-up.  He said he was at the conference where it was presented, and there was a lot of "bickering" (my word, not his).  He said he strongly disagreed with the recommendations.

However, I laid out all my concerns: fast rising PSA pre-surgery, unusual MRI pre-surgery, positive margin at surgery, and the AUA/ASTRO report.  He did agree to help me get a second path opinion -- if nothing else, to help me sleep better.    I requested it be done at JH.   It came back unchanged from the original path, except provided these additional tidbits not in original path report:  PM length 3mm, Gleason at the PM was 3 + 3 = 6, and it appeared to be intraprostatic. 

So, I am going to stand pat for now, hoping there wasn't any of my Gleason 4 ( I was 3 + 4 = 7 overall) at the margin that Epstein missed.  If Epstein is right, I will probably be ok long enough to die of something besides PCa or maybe never recur.  If he missed something, I am hoping my regular self-pay ultrasensitive tests will expose it before it goes too far (my surgeon uro only wants me to have standard psa tests, so I order my own ultrasensitive occasionally "on the side").  If recurrence, then I'll hope it's still in prostate bed and 70g will get it.

If somehow it had already, or in future, escaped prostate area, then not sure what I will do.  But that's for another day.  ("All in due time, my pretty" from Wiz of Oz).

Robert

Posted 9/12/2013 4:11 PM (GMT 0)
Tall Allen:

Surprisingly he didn't care if I was Gleason 6 or 7. His studies did not differentiate between the two.

For Gleason 6 and 7 combined his studies showed an 18 percent recurrence (measured by rising PSA) over ten years.

And a 99.9% 'cure' rate using salvage radiation assuming the radiation started before patients let the PSA rise past .1 (according to his official report on me).

Handwritten notes from him at time of meeting indicate that cutoff should be .04.

I'm seeking clarification now.

But if I'd just relied on these new guidelines I would have already adjuvant radiation, even though there would have been (unknown to me) an 82 percent chance I would have never needed it.
Posted 9/12/2013 5:03 PM (GMT 0)
BobbieSan:

Sounds like you and I have a lot of similarities.

I can't tell you how much clarification I got with a one day visit to Dr. D'Amico at Dana Farber in Boston.

He specializes in guys in exactly our situation - post surgery, postive margin.

His name is all over the studies in this field, and I really respect the fact that even though he could have treated me and gotten the $100,000 for his practice he advised against it.

And it wasn't some noncommittal 'you decide' sortof thing. He was quite specific about his reasons.

I'm sortof astonished that none of the other three oncologists I met with even mentioned his work, given the very specific subset I fell into, with just a positive margin and a low Gleason.

I wouldn't have known about it had my surgeon not specifically insisted I go see him.
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