A national radiation therapy registry for localized prostate cancer treatment?

As most regular readers and experienced prostate cancer advocates will be aware, there is a constant stream of published case series reporting data on outcomes of men treated with a variety of different types of radiation therapy for localized prostate cancer … but very little data (actually near to none) comparing one type to another.

The types of radiation therapy now being used for first-line therapy include:

  • Old-fashioned, photon-based, three-dimensional conformal beam radiation therapy (3D-CRT), which is not (or at least should not really be) recommended any more today for truly organ-confined prostate cancer.
  • Photon-based, intensity-modulated radiation therapy (IMRT), which can be targeted in a variety of ways
  • Photon-based, image-guided radiation therapy (IGRT)
  • Proton-beam radiation therapy (of varied types, depending on how it is targeted to the prostate)
  • Permanent-implant seeds (standard low-dose-rate “brachytherapy”)
  • Temporary implant, high-dose-rate brachytherapy (HDR)
  • Stereotactic body radiation therapy (most commonly, CyberKnife radiation therapy)
  • So-called RapidArc radiation therapy (which is a “short course” type of IMRT)
  • So-called TomoTherapy (an integrated method for planning, imaging, and delivery of radiation therapy)

Now all of these different types of radiation therapy appear to work reasonably well in terms of killing cancer in the prostate among men with low-risk, organ-confined disease (although many of the men being treated this way might do just as well on active surveillance), but they all appear to have somewhat different risks for side effects, based on the dose delivered, the accuracy with which it is targeted, and other methods used to protect rectal and associated tissues. In addition, the clinical outcomes of men with intermediate- and high-risk prostate cancer treated with these methods appear to vary as well.

All that the various case series can tell us is that men treated at specific doses of radiation at specific institutions over specific time frames with specific types of radiation therapy techniques have definable outcomes. They tell us little to nothing about how patients in series A treated at institution B over time frame C to D compare to patients in series W treated at institution X over time frame Y to Z. Why? Because we can rarely compare apples to apples.

It is time for the American Society for Radiation Oncology (ASTRO) and the National Institutes of Health (NIH) to step up to the plate and do something about this. If one makes the naive assumption that a key goal of radiation oncologists is to offer men the best possible radiation treatment for prostate cancer, it is high time that we had data that allowed us to know which form of radiation treatment really is the best. To do this we need a national prostate cancer radiation therapy registry that includes data on hundreds (better still thousands) of men treated with different types of radiation therapy and for whom standardized data are collected and entered over time. Such data would include (at a minimum):

  • The patients’ diagnostic characteristics (PSA level, clinical stage, clinical Gleason score, and other biopsy-based pathological data)
  • Dates of all treatments
  • The type of radiation therapy given, in detail, along with the dose level and other relevant criteria
  • Whether neoadjuvant or adjuvant androgen deprivation therapy was given in association with the radiation therapy, and if so what type and for exactly how long
  • The follow-up PSA data over time (according to a standard set of criteria)
  • Data on side effects associated with treatment during therapy, at 3 months, at 6 months, at 12 months, at 2 years, and at 5 years
  • Whether salvage androgen deprivation therapy (or other salvage therapy) was required, and if so what, when, and why
  • If possible, prostate cancer-specific and overall mortality data

Now many institutions may also want to collect other specific data for their research as well … and that is fine. However, we would suggest that ASTRO, the NIH, and other grant-giving bodies could make it clear that (say) beginning in 2015 no grants will be given for any clinical research into the effectiveness and safety of any form of radiation therapy for prostate cancer unless such research includes the compilation of data into such a database. Furthermore, the Radiation Therapy Oncology Group (RTOG), which oversees most of the clinical trials for radiation therapy in America, should insist that all data on all patients treated for localized prostate cancer in RTOG-sponsored trials should also be entered into this database.

Such a database would be (a) prospective; (b) standardized; and (c) evaluable over time. It could be used to compare outcomes of patients in series A treated at institution B over time frame C to D to patients in series W treated at institution X over time frame Y to Z. Better still, it could be used to compare outcomes of all patients treated using radiation type E at dose F (at any institution) to patients treated using radiation type R at dose S over time frame T to U. In other words, it is a system that would allow us to compare apples to apples as opposed to the current mess. Furthermore, the FDA could consider making approval of new radiation technology used in the treatment of prostate cancer contingent on the submission of data to this national registry in order to establish whether the new technology really was any better than current technology.

The “New” Prostate Cancer InfoLink does not expect ASTRO or all members of the radiation oncology community to embrace this idea with enthusiasm, and it is certainly not the perfect solution to a very complex problem. But it would be a beginning. And if the radiation oncology were to “go there” … maybe the urologic oncology community might go there with them, and we could build a real national prostate cancer registry and do away with all of the separate funding of case series using different study criteria … few of which are of any value to the patients whose bodies are “donated” to the cause of academic publication. Such a real, prospective, national prostate cancer treatment registry could encompass data on all forms of treatment for localized prostate cancer, and get past the old-fashioned, competitive, institutional databases which have more to do with institutional prestige and marketing than they do with improving patient care.

14 Responses

  1. This is really interesting. We are looking at treatment options for my husband’s prostate cancer. He is an active 75-year-old whose parents both lived to 95 years. We have followed “watchful waiting” for over 2 years but the PSA has been creeping up. The cancer is still contained within the gland but medical staff are concerned and are encouraging treatment to be on the safe side.

    A few questions I ask are: How do we know if the cancer would spread? How many have undergone the same treatment? How old have the men been? How many have suffered problems as a result of the treatment? No-one seems to be able to answer.

    My husband has no symptoms; it was his PSA that alerted us to the problem. So it is a very scary decision-making time and one likes to know about the risks: which is the best thing to do — get treated or let nature run it’s course? We will probably agree with gold seed therapy. The seeds are implanted and act like a target for the radiation and we all hope it is successful!! What do you think?

  2. This is one of the best articles Medscape has produced. To the point, you can walk into any restaurant now and easily see a menu of calories and cost of the food, but as a prostate cancer patient, just try and do that in the field of urology. What should be elucidating to patients, is seemingly avoided by physicians, incestuously protecting their data of success rates as well as percentages of patients with side effects or fistulas years later. And for anyone to suggest that “pilot error” doesn’t play into the concerns of prostate cancer patients looking into comparative treatment, they have not been paying attention.

  3. Dear Nancy:

    I would need to know more details of your husband’s condition and his PSA levels over time to be able to give you any type of detailed comment. We can do that (if you want to) through discussion on our social network.

    Key issues affecting decisions for your husband include his PSA levels over time; his Gleason score (probably 3 + 3 = 6); his clinical stage (probably T1c); the amount of cancer in his prostate on biopsy; and the results of other tests he may have been given.

    The role of gold fiducial seeds to guide radiation therapy is now commonplace. The really key question is whether there is a “best” form of delivering the radiation therapy after fiducial seeds have been implanted against which to target therapy.

  4. Well … Thank you for saying this is a good article … but I do feel I have to be clear (in their defense) that Medscape had nothing to do with this.

  5. Sitemaster,

    Just think if we could also aggregate similar data for radical prostatectomy, HIFU, active surveillance, cryotherapy, … all of it. Who in your industry has the ability to connect the dots on this one?

  6. Sorry, Sitemaster. I wasn’t paying attention when I opened this and thought it was a Medscape article. This one is clearly more profound in the big picture of urology … playing “What if …”

  7. This is an excellent suggestion to start to compile more useful facts to help the newly diagnosed make rational decisions. Ideally such a registry, with the suggested parameters, would encompass all current prostate cancer treatments. That should be the suggestion to NIH. Certainly providing information to such a national registry should be a requirement for any prostate cancer treatment paid for by Medicare, Medicaid, or the VA.

    How do we start? Starting a petition to ASTRO? For treatments paid with public funds, start an open petition to Congress?

  8. As I noted in the last paragraph above, “a real, prospective, national prostate cancer treatment registry could encompass data on all forms of treatment for localized prostate cancer.” However, that would be a harder sell to a more diverse group of people. Radiotherapy is (arguably) the appropriate place to begin.

    Re how to do it … That will be a challenge, but lobbying ASTRO, the National Cancer Institute (NCI), and others is certainly a place to begin. Prostate Cancer International is not a lobbying organization, but other prostate cancer organizations are (and Prostate Cancer International is a member of the Prostate Cancer Roundtable).

  9. What I find humorous, Sitemaster, is my post sharing that I am a successful post-treatment patient of HIFU … yet my post to Nancy was, uh, not posted! This is exactly what is happening in the field of urology. Procedures that are not found to be convenient are treated as if they don’t exist or have no merit. And right now, urologists that have financial interests in radiation treatment are over prescribing their procedure, to the demise of the public.

    And that is exactly what we are talking about here. To think that a national prostate cancer treatment registry would be embraced and accepted by the urology community … a group that historically refuses to share cogent data to their patients and is voracious at protecting their own self interests … seems to be naive.

    But I’ll begin by planting two seeds: my congressmen, Darrell Issa and my urologist, Dr. Stephen Scionti, FDA lead proctor from Boston.

  10. Sitemaster, I would like to use some of this article, quoted, when I write to the stakeholders such as NIH, ASTRO, NCI, etc. Do you wish to share your name as the author, or is that protected for some reason? May I include this citation and article when I write my letter? You have certainly hit the nail on the head here, and this idea deserves major attention.

  11. Dear Elucidated1:

    First: We have no record of any message left for Nancy. Perchance there was a computer glitch. These things do happen.

    Second: The entire reason the way the article was written to focus on the use of radiation therapy was because it might act as a pilot process for other forms of registry. You are correct when you state that it would be “naive” to think that anyone is going to invest in a national prostate cancer treatment registry until some form of pilot has shown its value. And urologists are not the only ones with self-interests here.

    Third: Please feel able to reference the article in writing to whomever you wish. My name is irrelevant. It is the concept that is worth discussion.

    Fourth: I am not sure how many HIFU procedures Dr. Scionti has done to date. Last time I heard it was (I think) over 600 … and yet not a single formal publication. I find this nearly as disturbing as the over-publication of case series of other types of treatment. The only thoroughly reliable papers I have seen on the application of HIFU appear to be the ones from Ahmed, Emberton, et al. in the UK. With no really compelling data published by experienced users of HIFU in the USA, one can hardly expect people to enthuse about this form of treatment. The failure of the manufacturers to coordinate, underwrite, and execute compelling clinical trials of HIFU is a whole other matter.

  12. Thanks. I’ll be using this article when writing to the stakeholders. Your ability to present such an obvious, succinct presentation of the issue is without peer, in my opinion.

    When I was diagnosed a year ago, it was quite a ride to figure out the choices … and having doctors suggest the choices and then say “Which one do you want?” certainly got my attention. And I have a lot more to say on the subject … but …

    Re: Dr. Scionti: My experience was off the scale. In my research, Dr. Scionti gave me his personal cell number, and allowed my to discuss all of the choices. He has now done 1,000 HIFUs, and is the lead proctor for the FDA HIFU testing. He is anal and obsessed with treatments that don’t compromise the patient with side effects. I could not find one of his patients that was unhappy, in my shotgun approach to interviewing HIFU patients.

    I’ll spare you any more … but I do agree with you that HIFU, like everything else, has been less than transparent in their data sharing … just like radiation, RALP, etc. But since urology is ripe with “pilot error,” choosing the correct treatment with the top physician you can find is huge. HIFU is just like RALP, the learning curve is very steep, and one must witness and perform hundreds before they work on me. And I do appreciate your civil and timely responses.

  13. Dear Elucidated1:

    I have never had any doubt whatsoever that Dr. Scionti is an excellent clinician with whom to discuss one’s therapeutic options.

  14. I’m 77 and I’ve just finished 22 of 45 treatments with proton radiation at Loma Linda. With 23 to go I have no side effects.

    As many are here from distant countries, states and cities, I’ve picked their brains re: side effects etc. Everybody seems like happy campers and this cheers me. Those that have finished 45 treatments try to say good-bye to everyone and freely answer all questions. I expect to be cancer free when I leave. A friend was diagnosed the same time as I and he elected the gold standard: surgery. e was out of the hospital in 1.5 days and recovered in 3 weeks. He wears the latest style in diapers. Some day he hopes to have control over his urethra.

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