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Just curious on how you feel about this trial from a top cancer hospital. Also includes short course of ADT. Explained below:
Proton Therapy and Brachytherapy.
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 (5 sessions, once a week for 5 weeks) 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 prior data suggests that this treatment is safe for prostate cancer patients?
Research has shown that hypofractionated whole pelvis proton therapy with brachytherapy, a type of prostate cancer treatment, is generally well-tolerated. In some studies, most patients reported only mild side effects. Approximately 91% of patients received brachytherapy, a form of radiation placed inside the body, as part of this treatment.
Some patients experienced side effects affecting the stomach, intestines, bladder, and urinary tract. These side effects were mostly mild to moderate, meaning they were noticeable but not severe.
Overall, while side effects can occur, they are usually manageable. This treatment is currently in a phase that evaluates both safety and effectiveness, indicating it has already passed basic safety checks.
Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about using hypofractionated whole pelvis proton therapy with a brachytherapy boost for prostate cancer because it offers a potentially more efficient and targeted approach. Unlike the standard treatment, which involves brachytherapy followed by 25 sessions of radiation therapy, this method condenses the treatment into just 5 sessions, each with a higher dose. This not only aims to improve the precision of targeting cancer cells but also reduces the overall treatment time, which could enhance patient convenience and quality of life.
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Assume the trial is using HDR Brachytherapy.
EBRT with brachytherapy boost has long-term good results.
SBRT monotherapy in five sessions has shown good results (recent data indicating it may be a little better than HDR monotherapy for some patients).
I would expect this proposed trial to have good results for favorable and intermediate patients.
I would think HDR boost would be preferred over LDR.
I have not had treatment yet. I am researching SBRT vs HDR vs Prostatectamy.
My Radiation Oncologist indicates she does not use spacer gel with HDR. Her experience and data indicates it is not necessary and may hinder treatment a little. Placement of HDR is precise enough to not need spacer gel.
In this trial, you would want to understand spacer gel usage for the external radiation, and how it may impact brachytherapy boost.
Best Wishes.
@charlesprestridge Yes it is HDR. They do not offer LDR anymore at the two COE's I've consulted with. The spacer gel & fiducial markers are placed at same time the HDR procedure is done under general anesthesia.
Unlike the trial doing the HDR procedure first then 5 Proton sessions the other option at different COE is 23 sessions of IMRT then the HDR brachy boost after.
Perhaps the spacer gel is not needed with mono HDR but if any EBRT is used before or after I would insist on it.
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1 ReactionSounds really good to me. Blast the cancer internally with HDR brachy and then externally with protons to finish the job and limit (🤞) side effects.
They already do this with all photons.
The once per week schedule will be a great help in reducing SE’s…
Phil
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1 ReactionThey used to do primary treatment radiation and salvage radiation in around 40 sessions. They now do it in about 20 sessions. That’s increasing the dosage, each time compared to the old times. The Insurance companies really like it, since it’s cheaper.
They proved it worked with IMRT why not give it a shot with the proton SBRT equivalent. The higher dosage should kill the cancer more efficiently. The big worry is the side effects to the bladder and rectum. Can you use a barrier (like SpaceOAR when they do the proton radiation? Definitely would like to protect the rectum since there’s gonna be so much more radiation.
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1 Reaction@jeffmarc Hi Jeff, Yes they will insert barrier gel & fiducials with the HDR Proton trial and just barrier gel no fiducials with the IMRT option. Like I mentioned, the trial is HDR procedure, barrier & fiducials first (done at same time under GA) then the 5 proton sessions. The other option is separate procedure to insert the barrier gel, then 23 IMRT sessions and brachy boost last. Both would include 4-6 months of ADT. The IMRT option has years of proven success rate. The trial does not have any long term data yet but similar trials have been done in Europe & Canada with success and the same usual standard of care side effects.
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1 Reaction@copyman
Five sessions once a week is not IMRT, It’s equivalent to how SBRT is done, The big difference is the amount of radiation that is given. It is a much higher dose with SBRT.
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1 ReactionSorry should have been more clear. I'm aware of the difference between IMRT & SBRT/Proton. The options presented to me were from 2 different top cancer centers. Again the trial from center #1 is 5 sessions of Proton with HDR Brachy. The other center #2 is the 23 sessions of IMRT and HDR Brachy
@copyman
Well, that makes it quite clear.
It’s a real toss up.
To tell you the truth, I don’t think there’ll be a whole lot of difference in side effects. Sure would be nice to get it over with 5 sessions plus HDR, Having to go back every day can be a real pain.
Can you get any information about whether there have been any really serious side effects or problems from the five session option.
I've asked the trial coordinator if any major side effects and he said he cannot discuss them because of trial rules. Besides the trial is still new and will only have 30 participants. The RO doc said he doesn't see the side effects being any different than 23 sessions of IMRT or perhaps even less. He based this on similar larger trials. The one thing holding me back is the brachytherapy procedure at both locations will be 3-4 hours under general anesthesia, intubated & on a ventilator. I've never had any surgeries and this scares the hell out of me! My cardio doc cleared me for the procedure.
@copyman
I didn’t realize brachytherapy Had such rigorous requirements. Being intubated is definitely different compared to most surgeries and all other radiation treatments I am aware of.
I’ve had six different surgeries for which they’ve had to put me under, No big deal, you just wake up when it’s over. When They operated on my spine, they Anesthetized me too much, Took a couple hours to wake up while I was in a groggy state. My wife was next to me trying to keep me awake. That was the only weird problem. I’m not sure if they intubated me, but they did say my throat would be sore after a couple of the surgeries.
In June when they put in my AUS, they have to put me under again. I really don’t worry about it.