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Post by mikescott on Jun 23, 2014 6:31:54 GMT -8
Some of the members of this site will be aware that there is now an open, randomized clinical trial of IMRT vs. PBRT for the treatment of localized prostate cancer (and about time too!). The trial is the co-called PARTIQoL trial and you can find the trial details here on ClinicalTrials.gov. The trial is currently enrolling patients at only two centers: Massachusetts General Hospital/Harvard (Boston) and the Abrahamson Cancer Center at the University of Pennsylvania (Philadelphia). However, it is my understanding that over the next year there will be another six PBRT centers that have agreed to enroll patients into this trial. I shall try to make sure that I keep the group informed as each new center comes on line. Two of the additional centers should be coming on line relatively soon. I consider this to be a very, VERY important trial for a number of reasons: - It sets a new standard for comparative effectiveness trials in the treatment of early stage prostate cancer
- If it can enroll enough patients in a timely manner, it will demonstrate that such trials really are feasible
- Based on my interactions with the trial principals to date, there is a strong commitment on their part to making sure this trial either does or does not, very clearly, demonstrate that PBRT has a value above and beyond that of IMRT -- and we do need to know this!
I would appreciate any help that other advocates can offer in telling newly diagnosed men about this trial. It is open to a wide variety of patients with clinical stage T1c to T2b disease at time of diagnosis.
Mike
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Post by KC on Jun 23, 2014 9:36:50 GMT -8
Hi Mike,
This looks interesting. It appears that it is strictly focused on side effects/quality of life, and with one of the stated assumptions being that the two treatments are equivalent with respect to cancer control.
Moreover, the study is more narrowly looking at SHORT-TERM side effects, and not (within the Estimated Primary Completion Date of January 2016) going to look at whether there are differences between the treatment modes in the LONG-TERM/LATE-TERM side effects.
Long-term/late-term side effects are not important to everyone. I’ve said many times in regard to my own treatment journey: Once I decided to get treatment (a decision that in hindsight may not have been necessary), I decided on surgery over radiation primarily because of my young (49) age. I’ve gone on to say that since I was close to 50, surgery was a no-brainer choice (for me, I must emphasize), and if I was close to 70 radiation would have been a no-brainer choice if I chose to be treated (again, for me); but if I was at that in-between age of close to 60 (the “’tweener’ age for PC treatment?? hahaha) I felt the primarily short-term impacts of surgery versus the long-term/late-term impacts from radiation would have weighed more equally and made a treatment decision more difficult. Again, these were all MY perspectives at the time (5 years ago).
So, while it won’t be relevant for me as a primary treatment mode, since cancer control is roughly equal, I would like to see which treatment mode has better long-term in addition to short-term side effects…for the “younger guys” who might make a radiation treatment choice in the future. In fact, throw Brachytherapy into that mix as well…
Too bad the study is limited to only the two institutions, too. Well, this is how science moves…a little step at a time.
Final comment is that I'm a bit surprised they can get many men to randomize their treatment modes. Men usually get a mode stuck in their minds and (then) defend it to the bitter end...
Thanks for keeping us informed
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Post by Allen on Jun 23, 2014 10:57:01 GMT -8
Mike,
Thanks for posting that. I wonder how the costs of the treatment will be handled. I'm guessing that one must have insurance that will cover either treatment, or perhaps they are reducing the cost of proton treatment for the clinical trial?
It's too bad that they aren't testing IMRT against the newer pencil-beam proton machines that are cropping up all over the country - perhaps they will be included in the next phase you mentioned. Results from UFJacksonville and MDAnderson look very promising. I also wish they were randomizing a third group to SBRT, but I know there are other RCTs in the works comparing SBRT to IMRT. I know Loma Linda is testing moderately hypofractionated proton therapy.
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Post by Tony Crispino on Jun 23, 2014 16:16:21 GMT -8
This will be interesting. Just an outline of the Primary and Secondary Goals:
Primary Outcome Measures:
Efficacy of PBT vs. IMRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)
Secondary Outcome Measures:
Disease Specific Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Assess the effectiveness of PBT versus IMRT for men with low or low-intermediate risk PCa in terms of disease-specific quality of life as measured by patient-reported outcomes, perceptions of care and adverse events
Cost Effectiveness of PBT vs. IMRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios
Radiation Dose and Bowel, Urinary and Erectile Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function
Identification and Evaluation Biomarkers of PCa Behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy
Long Term Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Assess longer-term rates of disease-specific and overall survival as well as development of laste effects such as second cancers
My Take?
It's a pretty narrow window like KC says. Two years is not a long time and with radiation it's also long term SE's. The trial just started but it will accrue well I believe. I am not happy about the definition of IMRT. Most RO's will use IGRT today with intensity modulation photons. Mostly because of aiming mean better outcomes. Comparing PBRT to 7 directional conformal IMRT might not tell us much in ten years. Today there is SBRT, Tomo, various means of beacons and all kinds of seed options. What this story may tell us of any use is whether PBRT has any additional benefit or not in prostate cancer treatment. But not much else. As pointed out, the costs are enormous for PBRT. I can see a few centers not joining the trial.
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Post by mikescott on Jun 24, 2014 5:32:49 GMT -8
Getting trials like this funded when it will take 15 years to produce really meaningful data is REALLY hard these days (as Tony C. will well understand). The trial group is actually VERY, VERY interested in being able to do the sort of long-term trial that you all envisage ... but getting the money to do such trials is difficult to say the least because most NCI-funded trials are only funded for a maximum of 5 years. After than you have to re-apply.
With regard to how the costs of therapy are being handled from an insurance perspective, I will try to find out more in a few weeks. There is now a consortium of PBRT centers working together on future large trials of this type. As I understand the current situation all except three of the currently functioning PBRT centers AND those that expect to come on line in the next couple of years (e.g., the two at the Mayo Clinics in Rochester and Phoenix) have agreed to participate in this consortium.
It is also my understanding that the exact form of PBRT to be used depends on the center. In other words, the centers that are able to offer pencil-beam PBRT are allowed to do that.
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Post by Tony Crispino on Jun 24, 2014 18:21:13 GMT -8
Skepticism aside this is a good trial. Anyone looking for PBRT should hear about this opportunity. At very least the secondary method, which ever it is, is getting solid treatment for localized prostate cancer. Accrual should be easy.
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Post by KC on Jun 25, 2014 9:19:36 GMT -8
Do you think so? What do others think? My intuition was the opposite, for the reasons I alluded to earlier. I think it would be a challenge to accrue because it would be hard to get men to agree to randomize their primary treatment mode. What I wrote earlier was "... I'm a bit surprised they can get many men to randomize their treatment modes. Men usually get a mode stuck in their minds and (then) defend it to the bitter end..." (And I think you know what I'm talking about when I say " defend it to the bitter end"; JohnT, myself and others have previously discussed the psychology of decision making, etc.) People have loosely discussed the "need" for a randomized study of "radiation vs. surgery," and I think that would be VERY difficult to accrue men for because of what I mentioned, so maybe for discussion's sake, maybe the small differences between cancer control for this study of PBRT vs. IMRT and the likelihood of small differences between the short-term side effects will enable adequate accrual. Thoughts on accrual? |
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Post by mikescott on Jun 25, 2014 9:29:13 GMT -8
The trial managers are very conscious of the biases that patients can bring to enrollment in this type of trial -- justifiable or not. I think that this is exactly why there is an onus on us all as advocates to tell people that this is an important trial and encourage enrollment.
One could waste enormous amounts of time trying to persuade men whose minds are made up about therapy about enrolling in a trial like this. That would be pretty pointless.
The trick is going to be to ask men to enroll well before they have made their minds up, and ask for their help to solve what is a really serious question. Not every patient is as self-oriented as you seem to think. And if you had thought that you wanted IMRT and were then asked if you would be randomized to either PBRT or IMRT, why wouldn't you consider enrolling?
While I am not sure that enrollment will be "easy", I certainly think it is "feasible", and I think we have a role to play in encouraging it, which is exactly why I brought it to the attending of the members of this group.
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Post by Tony Crispino on Jun 26, 2014 7:59:48 GMT -8
Clinical trials that have active treatment against prostate cancer known to work in both arms will usually accrue. Both IMRT and PBT are known possible treatment choices and the centers that have PBT should be able to accrue this trial. Obviously centers without PBT will not participate.
I agree this should be talked about. Once accrual is filled then time tells us a lot. This is certainly a valuable trial.
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