Trying to decide on treanment

Depends on how much you favor proton and if you want 1-2 vs 5-6 weeks of treatment. I assume the proton is SBRT high dose type to give you the equivalent biological dose as the IMRT and the HDR and ADT protocols are about the same for both choices. The studies that have been done seem to show about the same long term (about 5 years) results for SBRT as IMRT at the same biological dose levels. That said I did not think there was enough difference to cash pay for Proton vs. having adaptive IMRT paid by my commercial insurance.

@jim18 Hi thanks for the reply. Yes the trial is hypofractionated whole pelvis proton therapy. If your insurance would cover Proton would you go that route?

This is from trial consent form:

Search > Prostate Cancer
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Compensation: Varies
Number of Visits: 5
Duration: 5 weeks (one Proton session per week)
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30 Participants Needed

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Trial Listing ImageAbramson Cancer Center at Penn Medicine logo
Proton Therapy and Brachytherapy for Prostate Cancer
Recruiting in Philadelphia (< 50 mi)
PM
Overseen By
Project Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Abramson Cancer Center at Penn Medicine
Must be taking: Androgen deprivation
Must not be taking: Therapeutic anticoagulation
Disqualifiers: Metastatic disease, Prior radiation, others
No Placebo Group
All trial participants will receive the active study treatment (no placebo)
Prior Safety Data
This treatment has passed at least one previous human trial
Approved in 2 Jurisdictions
This treatment is already approved in other countries
What You Need to Know Before You Apply
What is the purpose of this trial?

This trial explores a new method to treat prostate cancer that is high risk or may spread to nearby lymph nodes. Researchers aim to determine if combining two radiation treatments, delivered in fewer sessions with a higher dose each time, is safe and effective. This method, called Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost, combines proton therapy and brachytherapy. The trial seeks participants diagnosed with high or intermediate-risk prostate cancer, who have not received prior radiation in the pelvic area, and do not have certain health conditions like inflammatory bowel disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

What evidence suggests that hypofractionated whole pelvis proton therapy with brachytherapy boost might be an effective treatment for prostate cancer?

This trial will evaluate the safety and effectiveness of using proton therapy with a brachytherapy boost for treating high-risk prostate cancer. Research has shown that a shorter, more intense form of radiotherapy, combined with a brachytherapy boost, can be safe and effective. Studies have found that this approach has manageable side effects related to urinary and bowel functions, common concerns in prostate cancer treatments. Additionally, ongoing research compares this method to other treatments, highlighting its potential benefits. This suggests that the treatment could effectively target prostate cancer while minimally impacting patients' quality of life.

I would lean toward the 23 sessions of IMRT if it was VMAT

The brachytherapy with proton does also sound attractive too.

Ask yourself one simple question, forgetting about how many sessions are involved - long term it is irrelevant:
Do I want to be part of a clinical trial that shows that HDR + Proton therapy showed NO better results than a therapy which showed a proven 90% 10 yr success rate?
Or even further, a trial that had side effects either worse or more long lasting than the proven treatment?
I personally would not be part of a clinical trial if I did not have to be - ie: dead in 6 months if I didn’t try…
But you may want to do it in the name of science and that’s also a personal choice.
But you don’t have that kind of gun to your head so why take the chance?
A good friend just had HDR + SBRT (5sessions) at Sloan (with gel spacer). Three months out he is still having bowel SE’s; less with time, but still there. It’s not the proton vs photon question, but the very high doses of radiation administered both internally and externally. Protons can burn too!
Spreading the radiation out over 20-25 sessions is much gentler on the body; in fact some RO’s still do 36-39…the amounts of radiation are equal in most cases.
I consented to 25 sessions IMRT vs 39 for my salvage therapy to the bed/nodes after reading the clinical research showing that incidence of SE’s for both groups were the same after 6 months.
And of course, there WERE brave souls in that trial who exposed themselves to risk and allowed me to reap the benefit, no question. Would I have done it? Probably, only because of the travel time, inconvenience, bowel prep and all that. But HDR was never in the equation in my case (also Gleason 4+3 unfavorable) since my prostate had already been removed; and even though I feel HDR is an excellent treatment modality in some aggressive cases, it IS a huge wallop to the area and SE’s do seem to be linked to it much more frequently than with IMRT. Just my cowardly thoughts…Best,
Phil

Much of this decision should be about what you’re telling them you want, rather than what options they’re telling you to choose from.

(I also had a 7(4+3), so we had the same options available. I had 28 sessions of proton radiation + 6 months of ADT + SpaceOAR Vue. Being retired, working those 28 days into my schedule wasn’t a problem.)

You should ask yourself —> What are you looking for with your choice of treatment? What do you want? What don’t you want? What are the characteristics of each component of treatment being offered that gets you to where you want to be? What have you told them your preferences are?

Why choose to be in a trial? If one of your priorities is successful treatment, what certain value does being in a trial bring you?

What questions have you asked them so far that had led you to still be undecided?

For the "adaptive" IMRT, is that “90% success rate 10 years out” the average or the best/worst?

Are you using SpaceOAR Hydrogel or SpaceOAR Vue?

The short course of proton SBRT may increase the risk of urinary bother, given the higher dose each fraction. Dr. Rossi has a lot of information about proton in his portion of this 2023 Mid-Year PCRI presentation: https://www.youtube.com/live/WTqPnSRYtW4

—> Starting at 3:38:45

His comments about Proton SBRT start at about 4:30:45.

I wouldn’t leave it up to a coin flip. I’d make an affirmative choice on the one I preferred, because it’s a decision - the most important decision in my life - that I’d have to live with for the rest of my life.
================

Just to be sure: your MRI report made no mention of seminal vesicle invasion or perineural invasion, and your biopsy report made no mention of cribriform pattern, or intraductal carcinoma.

At 68y, was this your first PSA test? If not, what was your PSA Doubling Time?

Have you had a Biomarker (genomic) test and a Genetic (germline & somatic) test?

Some of those answers may help you decide.

@heavyphil
I know so many people that went with five sessions of SBRT radiation to treat their prostate, Including my brother at 77. It’s a very common technique. Many people also used proton instead of photon for those five sessions. Adding HDR to that is not that revolutionary. Combining HDR brachytherapy With IMRT is very common.

I just don’t see a risk to combining those two things since SBRT is used so much. Dr. Roach at UCSF Uses that almost exclusively. He speaks at a number of conferences about it.

What you need more information on is the specific and total Gys in each choice. You want the spacer in before HDR.
> How many Gys of HDR for each will be applied? Probably a single session vs. two but confirm. Although there is some leakage (therefore the spacer) in the local area there is much less off the target than any EBRT. Key is using HDR should significantly reduce the Gys of EBRT required.
> What is the field being treated by both IMRT & Proton. Does whole pelvis mean bones, femur? Radiation has a bad effect on marrow. The prostate bed, seminal vessels, and lymph nodes are the likely areas of first spread and small amounts numbers of cells are not picked up by PET scans (why a lot of RP patients have to have salvage radiation). I have seen studies that show no benefit wider full pelvis treatment but since both recommended it may be the same for both choices.
> What are the fractions (Gys) being used. Get it for all 5 Proton treatments since it states it increases with each treatment. The fact that it is once per week vs. all 5 in a week (typical SBRT) will give your body more time to recover from the high dose. IMRT is usually the same for each treatment so probably between 2 and 2.5 Gys x 23.
> What technology is being used? Adaptive IMRT should include IGRT (either CT or MRI) for dynamic positioning and VMAT (radiation delivered 360 degrees). Same for proton although they do not do a full 360 degrees but have no exit radiation.
> What ADT is required? Orgovyx has less side effects and does not cause a flare). Is it after treatment or before (more effective after treatment, but if started with treatment ok since that is 5 weeks)?

In answer to your question, I would have gone with proton if covered, but this was for the typical 20-28 fractions. I discussed the success rate of getting coverage for prostate cancer and was told that they got about half approved for commercial insurance if it was company paid without 3rd party utilization approval. Insurance company pay or 3rd party approval reduced that to low single digit. Best is classic Medicare for both proton or focal prostate cancer treatments. I did not want to delay treatment on what was likely to be a lost cause, especially since studies show about same side effects and effectiveness with IMRT/IGRT/VMAT. Just was not worth the expense, extra travel, and work disruption.

@brianjarvis
When my brother had five sessions of SBRT to treat his cancer, he did have urinary issues. Flomax resolved them and they only went on for a month or two.

Just got a call from a friend of his yesterday who is Having 20 sessions of IMRT. He said after the third session, he felt a lot of burning when he was peeing, and it was driving him nuts. He tried AZO and it did not help. I think cystitis is a common problem for people that have around 20 sessions of IMRT. We’ve heard many people in this forum, complain about cystitis issues. I know from personal experience that having close to 40 sessions, with the lower radiation, doesn’t seem to cause a big problem with Cystitis, in comparison.

@jeffmarc So many “if’s” with radiation treatments:

> proper full bladder/empty bowel routine (so that organs are in the same place every time).

> use of rectal spacers: trials also demonstrated improved GU, GI, and sexual benefits.

> Radiation can cause damage to anything it hits/lingers on. So very important for the duration of the radiation to be correct - not just the number of sessions and dose.

Like with your friend with the 20 sessions of IMRT, all these issues (and more) need to be discussed. (I had 28 sessions of proton radiation; only had 1 day of issues during treatments, and that was an inflammatory reaction to the radiation. Tamsulosin resolved that.)

There is the possibility of radiation-induced proctitis, cystitis, and enteritis. All these need to be discussed prior to treatments along with ways to minimize/avoid them.

I’ve attached a chart of all the possible side-effects my RO and I covered; we discussed ways to minimize/avoid each.

@jeffmarc So the purpose of this clinical study is…what?? To see if we can mix electrons and protons?
HDR+ IMRT or SBRT is already used frequently and is fairly successful.
So I have to assume that the proponents of proton therapy want to show that protons are equally - or more - effective than photons when used in combination therapy. Time will tell. Best,
Phil