Edward Soffen, MD, Chairman of Radiation Oncology at CentraState Medical Center, Radiation Oncologist with area of expertise in prostate cancer, talks about a new option that could help minimize the side effects of being treated for prostate cancer.
Interview conducted by Ivanhoe Broadcast News in August 2017.
I wanted to ask you about some of the concerns men have when they know they have prostate cancer and surgery becomes their best option. What are the side effects that most men are concerned about?
Dr. Soffen: Most men are concerned primarily about losing their ability to control their urine. They are concerned about incontinence and that can happen after the surgery, a small but real percentage of time. Men are also very concerned about their ability to achieve an erection after the surgery, they want to be able to maintain sexual relations it’s very important to them. So those are the two primary risks of the procedure that weigh heavily on their minds.
How real are those risks, what are the percentages of men that lose sexual function and also have some incontinence?
Dr. Soffen: About seven to nine percent of men who have the surgery will have some type of change in their life where they have to wear a pad. To be completely incontinent is very unlikely; less than one percent. But what we call socially acceptable incontinence, meaning they wear a pad and they and their spouse know about it but no one else does, that’s about seven to nine percent. Now the risk of impotence is about fifty percent and that’s sort of national average in the hands of good robotic surgeons. Fifty percent of men will require something else to help achieve an erection that’s suitable for intercourse.
Tell me about the SpaceOAR, prior to this was there any kind of protective measure that doctors use prior to radiation?
Dr. Soffen: The prostate and the rectum are intimately opposing each other. That’s why we can feel the prostate when we do a rectal exam. And we’ve been trying to dance around how to spare the rectal tissues for many, many years. Now we had a big advance about twenty years ago when we went from 3-D conformal radiation to intensity modulated radiation therapy, but we still had the problem that the front wall of the rectum was still getting a very high dose, and there was really nothing much we could do about it. Then this SpaceOAR which we use at CentraState was FDA approved about two and a half years ago. This basically injects a barrier, a gel, which moves the rectum a little bit further away from the prostate which allows the beam to come in and be absorbed by the prostate and the gel and not hit the rectal tissues.
What does that do then to those tissues, having that barrier?
Dr. Soffen: Having the gel move the rectum away from the prostate significantly lowers the dose of radiation that the rectal tissues get; minimizing collateral radiation to normal structures. Normal tissues don’t need to be irradiated if they’re not in the way. In the study that was done showing the efficacy of the SpaceOAR procedure there was a dramatic reduction in rectal toxicity. Meaning the side effects that men get both during treatment, bleeding, rectal pain, diarrhea and long term issues like ulceration, bleeding, even incontinence. So there was a dramatic reduction in the risks of those complications happening when men got the SpaceOAR gel.
You mentioned there had been studies on this prior to the FDA approval. Can you tell me what some of the statistics are, what is the success rate using the OAR?
Dr. Soffen: Well this was in a national study of twenty different centers where men were randomized to receive the gel or not to receive the gel, and they didn’t even know, they were blinded. They were put to sleep and then we opened an envelope and it either said gel or no gel. After a year the men became un-blinded and they knew whether they got it or not. There was a seven percent risk of rectal toxicity in men who did not get the gel. And there was a two percent risk of toxicity in men who got the gel. So there was a five percent reduction and that was strongly statistically significant. Another interesting thing that came out of the study was that we found that erectile preservation was much improved in the men who got the spacer gel. Not only did the spacer gel improve rectal dose, but it also improved the dose to the penile bulb which seems to be the area that can be scarred from radiation and cause erectile dysfunction. There were really several benefits that men enjoyed by getting the gel.
What does the OAR stand for?
Dr. Soffen: That stands for organ at risk. It creates a space for the organ at risk, which is the rectum and the erectile tissues.
If you could describe for me what this gel is made out of and how the procedure works?
Dr. Soffen: The gel is a polymer of poly ethylene glycol, which is all natural; it’s sort of like an epoxy in a way. We have a gel and we have the accelerant, something that causes it to gel very quickly. And these two liquids meet in a needle that is inserted right in the tissue between the prostate and the rectum. When those two liquids meet they gel in about ten seconds, so we have an ultrasound probe in the man’s rectum that allows us to direct the needle. The needle goes to the right space– we inject the gel and there the gel will sit unperturbed for three months. That’s long enough for them to complete their radiation treatment. After three months the gel starts to dissolve and the body just eliminates it and it excretes it. So it’s a very stable product for as long as we need it and then by six months it’s completely gone.
What’s the bottom line, what would you want the viewers to know about this option?
Dr. Soffen: I guess the take home point is this is a low tech kind of improvement that has dramatic results. And I think if a man has prostate cancer and he’s considering any form of radiation the question of, “am I a candidate for this SpaceOAR”, should be raised with his treating physicians. It’s a new product we’re trying to get the word out and I think most men, if given an opportunity to spare rectal tissue and spare possible complication rates down the line, would be very interested in having it.
Who are the best candidates?
Dr. Soffen: I’m going to reverse the question and say, who is not a good candidate. Someone who is not a good candidate would be a person who has cancer that is so locally advanced that it has spread outside of the prostate. Then I don’t think we would want to put the gel in which might move cancer cells even further away. Other than that if a man has prostate cancer that’s confined to the gland then they ought to be considered for it.
Anything I didn’t ask you that you would want viewers to know?
Dr. Soffen: I’ll tell you this– if I had prostate cancer I would really want to get the hydrogel.
Could you tell me a little bit about John? What stage was he in when he came to you?
Dr. Soffen: Well you know he had a very interesting story. I would say of all people who would benefit from the SpaceOAR it would be John. Now he has a problem, a medical condition called ulcerative colitis. In the past we would never treat someone with ulcerative colitis with radiation. Because that rectum is going to get such a dose that not only would it exacerbate but it could dramatically cause an ulcer that wouldn’t heal, that they would require a colostomy for. So in the past I would tell someone with ulcerative colitis you need to have the prostatectomy. Now that brings in all the other issues of incontinence and impotence and he just didn’t want surgery. He was like, I don’t want surgery I would rather have the cancer than leak and be impotent. So he investigated, he found a place that he wanted to be treated, but they didn’t do the SpaceOAR so he contacted me. And I said, you know I’m happy to do it but I think if you’re going to be treated you probably should be treated by the person who puts the hydrogel in. Because we know how to plan it, since we worked on the study. It does require special planning. He was very happy to be treated with us here and had an absolutely beautiful outcome. I never would have treated him without the hydrogel.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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Edward Soffen
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