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Data on Recurrence After SBRT for Intermediate Risk

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Posted 7/28/2018 4:42 AM (GMT 0)
Hello All:

I recently received my biopsy results, which were:

Right side: 6/6 positive cores, 3 at 3+3, 3 at 3+4. PNI confirmed in 2 cores. Total tumor burden from 15% to 35%.

Left side: 2/6 positive cores, both at 3+3. Total tumor burden 5% in both.

The biopsy was triggered by my urologist's DRE, where he identified a potential tumor on the right side graded at T2A.

According to the Sloan Kettering nonograms, I have 31% likelihood of organ-confined disease, 68% of extracapsular extension, 8% of lymph node involvement, 9% of seminal vesicle invasion.

PSA before biopsy was 6.1. I am 62 years old, and otherwise in good health. I live in San Diego.

I have already met with a surgeon, who recommended a robotic RP.

I also met with a radiation oncologist, who recommended SBRT, specifically, CyberKnife.

I am attracted to SBRT, because of the ease of treatment. I live an active lifestyle, and enjoy biking, weight training, and yoga, so a minimum of 2-3 months incontinence, plus longer-lasting "slip-ups" while engaging in my favorite pelvic-intensive activities, are strong negatives.

But my first priority is to lead with the strongest punch (for my situation) first, even if that means a lengthy rehab.

Since long-term survival rates are about the same for surgery and most forms of RT, the question becomes what is the likelihood of PSA failure for surgery vs. SBRT for intermediate risk PC patients? Have any random comparative studies been done on this issue? If not, what are the numbers from the best non-random studies? Do any of these break out the percentage of localized vs. non-localized recurrences (i.e. the cancer had already spread, so neither surgery nor SBRT could have cured it)?

Also, have any random comparative studies been done on the issue of sexual function after RP vs. after SBRT for intermediate risk patients? In other words, what percentage of guys returned to their pre-treatment level of function say within 1 year after treatment? And what was the fall-off say 3 years after treatment, when the negative impacts of radiation (if any) are normally felt?

Thanks for your help!


RichB
Posted 7/28/2018 4:57 AM (GMT 0)
See the links in my signature for SBRT data on intermediate risk

I chose it for myself because maintaining good erectile function was particularly important to me. i was looking at a 70-80% chance of maintaining potency after SBRT vs about a 37% chance after surgery, with nerve sparing. Here's an article about erectile function preservation after SBRT:

/pcnrv.blogspot.com/2018/03/erectile-function-after-sbrt.html

There have been no randomized studies comparing surgery and SBRT, but there has been one that compared external beam to surgery. You can read the results here:

/pcnrv.blogspot.com/2016/09/patient-reported-outcomes-from-protect.html

The oncological results were the same, but the trial had some issues:

/pcnrv.blogspot.com/2016/09/the-first-randomized-clinical-trial.html
Posted 7/28/2018 5:24 AM (GMT 0)
Rich -- your numbers are similar to mine. I was told there was a 60% chance mine was out of capsule and a 60-70% chance it was still confined to prostate bed. my treatment is in my signature. i just began my 9th year of remission. never incontinent. can have sex with the aid of Cialis.
Posted 7/28/2018 5:48 AM (GMT 0)
Thanks, F8, I've seen some good numbers on combo therapy. I intend to discuss it when I meet with a radiation oncologist at UCSD next week.

Tall Allen, that's a lot of great information, thank you so much.

I was interested in the following passage from the Protect report (unfortunately not broken out by risk level):

"Of the 391 men who underwent prostatectomy, 18 had primary treatment failure. Of those, 9 (2%) had a PSA level of 0.2 ng per milliliter or higher between 31 and 183 days after surgery; 5 received salvage radiotherapy and 1 long-term androgen-deprivation therapy within a year after surgery. An additional 9 men received adjuvant radiotherapy within a year after surgery, because of pathologic extracapsular (pT3) disease (8 men) or positive surgical margins (7 men). Stage pT3 disease was present in 114 of the 391 men (29%), and 93 (24%) had a positive surgical margin. Four of the 280 patients who underwent lymphadenectomy (1%) had lymph-node involvement. Of the 405 men who started radiotherapy within 9 months after treatment assignment, 55 (14%) had an increase in the PSA level of 2 ng per milliliter or more above the nadir after radiotherapy, of whom 3 underwent salvage prostatectomy, 14 received long-term androgen-deprivation therapy, and 1 received high-intensity focused ultrasound therapy."

So if I am reading this correctly, only 4.6% of the surgery patients had primary failure, or 6.9% if you also count adjuvant RT within a year as a failure. 13.6% of the RT patients suffered primary failure. So it would appear that the surgery patients had a significantly more favorable outcome. Despite that, similar numbers of patients "did something" about the failure, 15 for surgery, 17 for RT.

What is your interpretation of this passage?
Posted 7/28/2018 6:03 AM (GMT 0)
Taking a stab at answering my own question--

Maybe a chunk of the RT primary failures were technical failures only, caused by a PSA bounce of more than 2 (the definition of primary failure for RT) that later returned to baseline. Which might explain why a much lower percentage of the failed RT patients chose to "do something" about it.

Post Edited (RichBinSD) : 7/28/2018 6:27:52 AM (GMT-6)

Posted 7/28/2018 11:25 AM (GMT 0)
A post radiation PSA bounce is not a technical failure. It is a dynamic of the treatment that many men experience. It is simply a signal of a lot of the PCa dying off at about the same time. Remember, the prostatic cell is a very long living cell. The radiation does not initially kill all the PCa cells in the way surgery removes cells. Most of the cells are damaged and continue to live until the apoptosis occurs. Hence the slow PSA regression and often the bounce. While many continue to be alive they can not divide or spread due to the radiation damage and re no longer a threat.
Posted 7/28/2018 2:32 PM (GMT 0)
Remember that SBRT allows the immediate surroundings of the prostate to be included in the radiation field. Surgery can't do that, but can be followed by radiation later if the pathology report reveals suspect areas.
Posted 7/28/2018 3:37 PM (GMT 0)
Comparing bcr after surgery and radiation is a bit as comparing apples and oranges, since they are defined in a very different way. Some publications indicate that the bcr survival curves after radiaton have to be corrected by some number of years to be superimposed to the surgical curves that always show an earlier decay but it is not clear which is the best definition of this lag. A better comparison could be performed by choosing the overall survival for comparison, but this criterion is also biased since the studies required a long follow-up and time ago radiation was reserved for older patients and it was technically different. Therefore, IMHO there is not a simple answer to your main question.
You will find many contradictions in the medical literature about all your different (and difficult) questions. It is not a good idea to blindly believe what a single article claims to show. Of course, confined tumors have a better outcome after surgery. The risk is decreased roughly in about a 2-3 factor. The difficulty is knowing what is your stage beforehand. It is generally admited that surgery is associated with early incontinence and permanent ED in many cases. Most people return to be contnent in a few months. Radiaton may cause irritative urinary and bowel issues that are usually temporary as well.
Posted 7/28/2018 4:15 PM (GMT 0)
jmadrid:

Reread the Protect trial report and they said basically the same thing:

"Between-group comparisons with respect to treatment failure require considerable caution because of the different definitions and variables used. In the case of prostatectomy, primary treatment failure can be inferred at an early stage because of detectable PSA postoperatively. In the case of radiotherapy, treatment failure can be determined only from subsequent increases in PSA levels that might occur much later."

So while the difference in initial failure rates is concerning, perhaps it is a case of apples and oranges.
Posted 7/28/2018 4:24 PM (GMT 0)
The ProtecT oncological results were problematic. As you rightly say, the patients were mostly low risk. The radiation patients only received 74 Gy (which is a much lower biologically effective dose than IMRT as given now (about 80 Gy) or given with SBRT). I expect to see the survival curves diverge at 20 years.

I agree with you that the reason that so few RT men "did something" is because biochemical failure after RT is often not the result of clinical failure, whereas it probably more often is after RP.

For your 'unfavorable risk" PC (it is "unfavorable" because of the high percent of positive cores) there isn't a lot of reported data (this is a recent subcategory). One SBRT study from Philadelphia reported 90% 5-yr freedom from biochemical failure, and Katz reported 7-year disease-free survival of 68%. There are very good numbers for brachy boost therapy (10-year biochemical recurrence free survival was 92%):

/pcnrv.blogspot.com/2017/05/brachy-boost-therapy-should-be-reserved.html

The cost is much higher rates of late urinary toxicity.
Posted 7/28/2018 4:45 PM (GMT 0)
I had negative nomographic results for containment as well...post op pathology show contained in Prostate...this not an endorsement for surgery...actually if I knew then what I now ida don BT
Posted 7/28/2018 5:04 PM (GMT 0)
Thanks again, Allen. Very helpful information.

But depressing, if true. I had assumed I was standard intermediate risk, what PCRI calls "Basic Teal," which usually means one modality of treatment is sufficient.

If I have to do HT + BT + non-SBRT RT-- uggghhh.

But you gotta do what you gotta do.

I will be consulting with a surgeon and a radiation oncologist at UCSD next week and will ask them about the advisbaility of RP vs. SBRT vs. combo therapy.

I am also strongly considering consulting with Dr. Scholz or Dr. Lam in LA, because they seem to be up on the latest and most effective treatments for "unfavorable risk" PC.
Posted 7/28/2018 5:20 PM (GMT 0)
Tall Allen:

I went and read Dr. Katz's report on 7 year outcomes, and the 68% disease-free survival rate equated to the D'Amico high-risk group, which is characterized by "PSA > 20 or Gleason sum of 8–10 or clinical stage T2c or higher," none of which applies to me (PSA = 6.1, 3/12 cores = G7 (plus 5/12 = G6), clinical stage T2a).

Are you sure I should be classified with the high-risk folks?
Posted 7/28/2018 5:21 PM (GMT 0)
//

Post Edited (F8) : 7/28/2018 11:40:58 AM (GMT-6)

Posted 7/28/2018 5:24 PM (GMT 0)
Rich - I really applaud the way you are going at this. good luck to you!

oh you might find this story of interest.

fortune.com/1996/05/13/andy-grove-prostate-cancer-cover-story/
Posted 7/28/2018 5:37 PM (GMT 0)
Thanks, F8.

I have read the Andy Grove story, and was greatly impressed by it.

One of the nuggets I took away from it is that researching your best PC treatment strategy is like researching your best investment strategy. It is too important to leave to the experts alone. You need to educate yourself to the point that you can ask the experts the key questions.

Certainly, our PC numbers are very close, and if Tall Allen is correct, I may be following you down the road of combo therapy.

Did you have any issues in getting insurance coverage on all the arms of the combo therapy?
Posted 7/28/2018 5:48 PM (GMT 0)
Rich -- I am in California and my wife is a teacher; we have great insurance. throughout my treatment the only thing I ever paid was $15 office visits. oh, they tried to get me to use an older, cheaper drug once or twice but when I protested they paid for the good stuff. so I never had a problem with anything.

the treatment was a marathon and Lupron was miserable but my main concerns were 1) living and 2) continence.

good luck man!
Posted 7/28/2018 6:54 PM (GMT 0)
Rich, welcome from a fellow So Cal guy. I'm also a combo therapy guy and I'm doing very well, but I'm also wondering if that would be more than you need in your case. Certainly would be good question for your next RO appt. BTW, I see Dr Lam and I found him to be very helpful from a generalist perspective (in fact, it's been the best doctor-patient relationship I've ever had), although it will probably be pointed out that specific ROs will know more about their radiation treatments than him. To that point, since you're willing to travel a bit at UCLA you have both Dr King for SBRT and Dr Demanes (who is semi-retired) for HDR brachy--both will spend a lot of time with you on the educational front, although I'm not sure how easy it is to schedule an appointment with Demanes nowadays.
Posted 7/28/2018 7:23 PM (GMT 0)
Rich-

It's a different study from Katz - he does a lot of them (bless his heart):

/www.ncbi.nlm.nih.gov/pmc/articles/PMC4937020/

Here's the Philadelphia story:

/www.frontiersin.org/articles/10.3389/fonc.2014.00312/full

I think that Prostate Oncology Specialists are good if your cancer is incurable. They are not the specialists to see for curable cancers, imho. They know a LOT less than specialists in the area. In San Diego, Don Fuller treats a lot of SBRT patients. As MichaelT suggests, Demanes is great, but he seems to poke in and out of retirement. Dr Chang has taken over for him at UCLA. He mentored Mitchell Kamrava who is now at Cedars Sinai.
Posted 7/28/2018 7:34 PM (GMT 0)
Rich-

Here's an article on distinguishing the two intermediate risk subcategories:

/pcnrv.blogspot.com/2016/08/distinguishing-favorable-vs-unfavorable.html

Both HDR brachy monotherapy and SBRT monotherapy are in clinical trials for "high risk" PC and results look good so far - so it is likely that they are good for unfavorable intermediate risk as well. But not a lot of published data on the subgroup.
Posted 7/28/2018 8:32 PM (GMT 0)
Thanks again, Allen.

As you indicated, I see the revision of the intermediate risk definition in the 2016 Katz study vs. the 2014 study.

Somewhat weird that the rates of biochemical failure after 7 years were essentially the same (~32%) for unfavorable intermediate risk in the 2016 study as the flat-out high risk in the 2014 study.

In your opinion, what would be the key factors that could be discoverable before treatment (by MRI, color Doppler, CT, etc.) that would tip towards combo therapy rather than monotherapy?

Point taken about prostate oncology specialists.

Would you say that Dr. Fuller is one of the best SBRT practitioners on the West Coast for patients with my profile?
Posted 7/28/2018 10:33 PM (GMT 0)
Welcome Rich, though it's too bad you need to be here in our club.

I'm also in San Diego (North County), and am being treated by UCSD. Unfortunately, I'm G9 (was G8 on UCSD pathology, but second opinion from JHU came back G9).

I initially leaned towards RP (after talk with UCSD urologist), but then after investigating and lesser reoccurrence rates for high risk with HT + RT + LDR BT, I've opted for the "triple play".

I've found all the UCSD doctors to be great and good patient interaction skills, but I've been disappointed on occasion with some of the support staff particularly not sharing in my sense of urgency. I will say after living 63 years with little interaction with the medical community other than the broken bone here or there, it's a pain dealing with the medical / insurance complex.

My insurance carrier is Aetna (PPO) and other than having no fun getting to my out of pocket max (which with PC you will probably do the same), their coverage has been good. In my case out of pocket max was $7150 (which I had in my HSA), and now everything is 100% covered. I was able to self refer and talked to several RO's including DR King at UCLA regarding SBRT.

You sound on top of your situation and already doing great research -- and yes, while you likely will find great doctors, you really want to be your own case manager as you have the most skin in the game in terms of your outcome.

Finally, there's a San Diego support prostate group that meets once a month in La Jolla -- it probably makes sense to at least go to one meeting. If you can't find via google, let me know and I'll post a link here.
Posted 7/28/2018 10:47 PM (GMT 0)
That's some great info, CAdogsRus.

I also have Aetna PPO with a $5K deductible, which I will pay in a heartbeat if they don't nickel and dime me on getting the best treatment, as supported by scientific evidence. So glad to hear they didn't do that to you.

Why did you decide to go with IMRT instead of SBRT for your combo therapy?

Did you have any interaction with Dr. Arno Mundt of the UCSD radiation oncology department?

I have heard of the San Diego support group, the Informed Prostate Cancer Support Group, https://ipcsg.org/ I just missed the July meeting. The speaker at the August meeting is Dr. Chris Kane of UCSD, who is supposed to be one of the top PC surgeons in SD, so I am planning to attend.
Posted 7/28/2018 11:32 PM (GMT 0)

RichBinSD said...
That's some great info, CAdogsRus.

I also have Aetna PPO with a $5K deductible, which I will pay in a heartbeat if they don't nickel and dime me on getting the best treatment, as supported by scientific evidence. So glad to hear they didn't do that to you.

Why did you decide to go with IMRT instead of SBRT for your combo therapy?

Did you have any interaction with Dr. Arno Mundt of the UCSD radiation oncology department?

I have heard of the San Diego support group, the Informed Prostate Cancer Support Group, https://ipcsg.org/ I just missed the July meeting. The speaker at the August meeting is Dr. Chris Kane of UCSD, who is supposed to be one of the top PC surgeons in SD, so I am planning to attend.

I was very interested in SBRT but I couldn't find anyone that offered brachy boost with SBRT, and the Ascend trial (I think I've got the right one) strongly favored the addition of brachy.

I almost went to see the third party radiation group affiliated with Palomar as they said they would offer SBRT (not everyone does SBRT with high risk), but I cancelled after I got concerned reading some things on Palomar and being concerned about whether it was wise to not be at a NCCI facility.

I've heard good things about Dr Fuller, and he did a gave a good presentation at a recent Saturday at the SD support group I mentioned.

I know of Dr Mundt, but I'm seeing Dr Einck. From what I discerned at the SD meetings (there's easily 70 to 100 who attend, many spouses as well), the UCSD group and Dr Fuller receive positive reviews.

And back on Aetna, my plan was a $4000 deductible, I pretty much paid all until that point. Then they covered 70% until I hit the $7150, now they pay everything -- thank goodness. For example, for PC purposes, not ED, I'm on 5 mg of Cialis. I just got a 90 day refill -- $0 to me, insurance paid $1364!!! But Aetna has been covering everything and in some cases they say it's not chargeable by the facility and I owe nothing.

I will likely be at the SD August meeting. If I am, you might spot my Mini Cooper with the dog on the back -- it's hard to miss. I'll be in the middle of my radiation -- I have my planning scan Monday, then 7 to 10 days later start 25 treatments of IMRT, Monday thru Friday. I'm cautiously optimistic that all goes well as 3 months into Lupron my side affects have been minimal. Right now, the thing I look forward to least is the one day of the brachy seeds implant -- that doesn't read like it's a lot of fun. But all in all, I think my route looks easier than surgery not to mention G9 likely would still be radiation after surgery.

If I can answer more questions, let me know. Off to dinner in South Park at Eclipse Chocolate and Bistro, highly recommended.
Posted 7/29/2018 12:50 AM (GMT 0)

Rich said...
In your opinion, what would be the key factors that could be discoverable before treatment (by MRI, color Doppler, CT, etc.) that would tip towards combo therapy rather than monotherapy?

There is nothing in terms of imaging that will help you. It is purely an internal matter. You have to decide for yourself whether the available evidence justifies the decision for you. There is more hard evidence for brachy boost for unfavorable intermediate risk, which is a relatively new category. In Meier's study where he lumped together all intermediate risk patients (and we can safely assume that most were favorable, they saw 97% 5-yr freedom from biochemical failure. Monotherapies have lower expected toxicity than bimodal therapies.

/pcnrv.blogspot.com/2016/09/5-year-sbrt-trial-high-cancer-control.html

Rich said...

Would you say that Dr. Fuller is one of the best SBRT practitioners on the West Coast for patients with my profile?

Yes. He has almost as much experience at it as my RO (Chris King at UCLA, who pioneered its use for PC in 2003). He uses a slightly different method called "heterogeneous planning" that more closely approximates the dosimetry one gets with HDR brachy. King does homogenous planning. As far as I can tell, outcomes are about the same.
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