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    Old 01-13-2022, 12:57 PM   #1
    IADT3since2000
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    Lightbulb Gaining High Confidence in Long-Term Success and Safety of Radiation for Prostate Can

    Those of us facing and researching treatments for prostate cancer these days will soon come across some impressive success figures for modern, image guided radiation, as well as some remarkably low figures for bothersome long-term side effects. The evidence for some of the older versions such as IMRT, especially image-guided IMRT, naturally has a longer track record for effectiveness against the cancer and for very low side effects, but newer forms, such as SBRT (also often referred to as "hypofractionation" or CyberKnife but not limited to that system), have interim, fairly long-term evidence of arguably somewhat superior effectiveness and side effect risks that many patients are now finding acceptable.

    A key question for some of us choosing therapy is whether the follow-up period for medical research studies is long enough to give high confidence in the success and safety results, especially for the newer forms of radiation. Prostatefree recently raised these issues in post #10 on the thread "Newly Diagnosed." This initial post on this thread uses those thoughts as the jumping-off points for this discussion of follow-up adequacy for medical research on modern prostate cancer radiation, viewed from my perspective as a 22 year survivor of prostate cancer, now disease free and with mild, non-bothersome side effects at nearly the 9 year point since radiation.

    [QUOTE=Prostatefree;5514603]
    Quote:
    Originally Posted by Prostatefree View Post
    Men who have chosen radiation seldom come back to complain about long lasting side effects occurring out past 5 or 10 years. They chose this path understanding there will be none.
    Yes, the low rates of significant side effects are indicated by the low complaint rates - certainly not zero, but low. The low rates are also indicated by the fact that there are few doctors specializing in prostate cancer radiation side effects in contrast to the far larger number of doctors who specialize in treating side effects of prostate cancer surgery. However, I suspect that most of us were advised of the risks of side effects: low, yes, but possible. Not "none." (Now if you are talking about other non-radiation treatments, such as HIFU, some of those patients were falsely told there were no side effects. Even proton beam proponents, while having a good product generally, sometimes implied there would be no side effects when the reality was that there was some risk. That's not true for other forms of radiation; risks were acknowledged.)

    It is also widely accepted that any long-term side effects that are going to appear may take some time to do it; they may not appear until several years after treatment, unlike surgery, where the side effects tend to be worse at the beginning, last for about a year if they are going to be "temporary," and then continue if they are going to be long-term. Research strongly indicates that there will be no side effects long-term or only mild side effects for the vast majority of modern patients getting IMRT (a version of external beam radiation), even after many years, giving assurance of a lifetime free of bothersome side effects. Based on analysis and interim results, there is strong evidence that the rates of bothersome side effects for image-guided IMRT will be even lower. The book is still being written, in my view, for newer approaches such as SBRT, but we already have some encouraging data, at least according to expert radiation oncologists.

    Quote:
    Originally Posted by Prostatefree View Post
    I am not certain there are any studies out there at 10 years for some of the newer radiation methods. I believe there are now 5 year studies.
    That's generally the way I see it too for the newer forms. I'm expecting we will have studies with average (median) follow-up of 10 years within the next few years.

    That said, there are some studies with long follow-up, and here is a link to one (also a link to the free complete paper at that site) that was a huge boost to my morale back in 2010 when it was published, a boost in part because that study did have long-term follow-up: https://pubmed.ncbi.nlm.nih.gov/20847945/ . In essence, Dr. Michael Dattoli, MD, a pioneering radiation oncologist, and his team, described their very encouraging results for a combined brachytherapy plus old-style external beam radiation. Dr. Dattoli wasn't just any doctor. He was very prominent in the field, a veteran of the famed radiation oncology group at Memorial Sloan Kettering Cancer Center in New York City before moving his practice to Florida, and well-known in survivor circles and education/support groups from his presentations at conferences for patients.

    He and an also prominent "rival" in Atlanta, Dr. Critz, were kind of battling over who had the best approach for combined brachytherapy plus external beam. The key difference was that Dr. Dattoli would implant radioactive seeds and then have his team do the course of 3-D conformal external beam radiation (which was at the leading edge of the art at the time with Memorial Sloan Kettering having done leading work), while Dr. Critz would do the seeds first, and then try to scatter some of the external beam radiation (mostly likely the "conventional version, not 3-D conformal) off the seeds when he followed up the seeds with external beam. Both were going through the rigors of tracking their results, following their patients over time, and formally publishing their reports in major medical research journals such as the Journal of Urology. I was interested in both and was watching closely; though I believed I was beyond cure, I figured that one of these guys would be my best bet if and when technology improved enough to give me a shot.

    Dr. Critz's team had published a report in 2004 (https://pubmed.ncbi.nlm.nih.gov/15538238/) of their results on 1,469 consecutive patients treated from 1992-1998 and followed for an average (median) of 6 years, with all treated at least 5 years earlier. Low, intermediate- and high-risk men were included, and success (non-recurrence) rates, of course outstanding for the low-risk men whom we now know should probably have been on active surveillance that did not exist then, were 80% for intermediate risk men and 61% for the high-risk men (impressive for high-risk men, and better than for many high-risk patients reported in clinical trials for surgery, but not exactly encouraging for me as a then "young" 61 year-old, high-risk patient, arguably very high risk).

    And also worrisome in the Crist results, 24% of recurrences for all men in the trial, including many low-risk men at a low risk of recurrence, occurred more than five years after treatment; it is virtually a sure bet that that post-five-year recurrence rate, diluted by so many low-risk patients in the study, was substantially higher for intermediate- and especially high-risk patients, but that information is not in the study abstract. I eagerly awaited updates for the Critz team results, but the years were ticking by with nothing more published (til 2013 - more about that later).

    So, for me it was kind of like watching a horse race in very slow motion.

    Then around 2007 the Dattoli team began publishing a number of intriguing papers, pointing toward remarkably encouraging success where it really counted: for intermediate-risk and high-risk men. Then came their 2010 paper. What was especially remarkable in that Dattoli paper was the long follow-up: the vast majority of these patients did not have recurrence as judged by PSA, and the median follow-up for these non-failing patients was 10.5 years, which enabled the research team to project results to 16 years! Indeed, 89% of intermediate-risk patients and 74% of high-risk patients had not recurred! An abstract of this study with graphs is available at no cost at https://pubmed.ncbi.nlm.nih.gov/20847945/ , and a link to a free copy of the complete paper is at that site. A stunning finding was that the non-recurrence success lines on the graph became virtually stable after about five years after treatment - virtually no more recurrences after that point!


    Now the patients in this study were treated between 1992 and 1997, so the radiation and suspportive technology employed in the study, at the time of the paper's publication in 2010, though obviously highly successful, was obsolete as subsequent research had shown that newer technology was superior. What that strongly implies, but does not prove, is that modern technology should have even better very long-term results! Also, while cancer control was excellent, there have been concerns about side effects, though the Dattoli team had published results that were also encouraging on that score; fortunately, decreased side effects is one area of substantial improvement due to progress in technology.

    Because radiation therapy and its supportive technology has been evolving so rapidly, with an especially large burst in progress around 2007 when there was major progress in deploying advanced imaging for planning, targeting and dose delivery, there are obviously limits on the length of follow-up. That said, 2007 is now 15 years ago, and the radiation community does a lot of research; "a lot" includes 2,029 papers published to date on IMRT (www.pubmed.gov viea search string - IMRT AND prostate cancer ). Also, while we sometimes can't pin down the exact amount of progress, we can sometimes see that outcomes are very likely to be at least as good as an established therapy. For example, we know from research that modern IMRT with image guidance results in very low rates of significant rectal side effects, but the addition of SpaceOAR technology should make those rates even more favorable.

    As another example close to my own experience, a German study of "escalated dose" image-guided TomoTherapy radiation, with 5 and a half year follow-up, that almost matches the kind of therapy I had, is available at https://pubmed.ncbi.nlm.nih.gov/31873779/ . It shows great success rates for intermediate- and high-risk patients (as well as low-risk patients, of course); at an average (median) follow-up of 5 1/2 years, with 5 years for the following, results were 92.8% recurrence free survival for intermediate-risk patients and 70.4% for high-risk patients. It also shows remarkably low rates of urinary and gastrointestinal side effects, which is consistent with my own experience. (I had a slightly lower target volume dose, 78 Gy, and a pelvic radiation dose which I believe the patients in the study did not have; I also had 18 months of ADT in support (actually ADT3), and the abstract does not state whether or not these patients had ADT.)

    Also, consider SBRT, commonly known as CyberKnife, which is actually one of the more recent major developments in radiation. I was among those who was really skeptical whether radically reducing the radiation sessions from around 40 to just 5 for SBRT, while reducing the total dose, would be enough to be effective against the cancer, and whether substantially boosting the dose per session would drive a substantially higher rate of long-term side effects; but I and others agreed that clinical trial results were the way to determine success or failure. Dr, Christopher King, MD, was arguably the leading pioneer, with a Phase II trial for low-risk patients started in 2003. (Back then AS was in its infancy, and it was not known that most such patients should do AS and defer treatment.) Results with five full years of follow-up were published in 2011 (https://pubmed.ncbi.nlm.nih.gov/21625167/). Another combined study from several institutions, including intermediate risk patients, is available at https://pubmed.ncbi.nlm.nih.gov/32529134/. As you could have guessed, average followup (median) was short, just 3.1 years - too short for high confidence, though encouraging, but the patients who enrolled earliest had a followup of 10.8 years. These and other studies of SBRT involving Dr. King are available at www..pubmed.gov via the search string - king c [au] AND prostate cancer AND SBRT - which resulted in a list of 27 papers. The site has free brief descriptions of key results and features ("abstracts" of the studies) and sometimes links to free copies of the complete papers.

    So ....., what is today's patient to do when considering one of the newer forms of radiation that should be even better than forms with excellent results but that have a much shorter track record? My own story illustrates the situation facing many of us as we tried to decide what to do with promising radiation technology that does not have a specific long track record.

    My own approach was to focus on the "should be even better than" aspects plus assessing whether increased risks were involved. I could have chosen regular IMRT, perhaps with seeds, as in the Dattoli study but with iMRT, which the Dattoli team was using in 2010, instead of 3D-conformal radiation, which was no longer the state of the art. Indeed, despite living in Virginia and the prospective great inconvenience of spending a couple of months in Florida, I talked about an appointment with the Dattoli team in Florida, and I got in a clinical trial for an advanced scan (feraheme USPIO) that Dr. Dattoli was involved with. His team was then treating spot metastases outside the range of the usual radiation treatment, and I figured that they would be able to treat the prostate and pelvis as well as any spot metastases, which my doctors had all considered likely. However, the surprise result for me was that the very sensitive feraheme scan found I had no detectable metastases!

    This opened up the possibility of getting treatment locally. TomoTherapy was available at a respected regional center only a few miles from my home, and I was impressed with the rationale for TomoTherapy, which features a radiation gun that fires its beams from a vast number of points as it rotates through a helix surrounding the patient, even shooting beams from under the special table on which you lie, with the strength of those beams adjusted for the added resistance of the table. The idea is that healthy cells only get radiated occasionally because there are so many beams from many angles that hit the target - think pincushion. I researched Tomotherapy research and found scant evidence of results, and no long-term results. But I was comfortable with the concept: the results "should be even better than" standard IMRT, especially because of the advanced imaging guidance, which involved a low-level CT scan before each session to confirm and adjust the planned target. I was also reassured that the extra radiation from the CT scans would not increase risk of side effects. So ..... I took the plunge, aware that there was no research that guaranteed the efficacy and safety of my treatment. That has changed as research has had time to mature. There are now many papers that have addressed the use of Tomotherapy for prostate cancer, showing encouraging results, as in the German study of Tomotherapy described earlier, though truly long-term results are still maturing.

    Finally, a word about long-term results from the Critz team (as described above, published in March 2013 when I was actually undergoing Tomotherapy radiation (plus supportive ADT3): https://pubmed.ncbi.nlm.nih.gov/23103235/ . A total of 3,546 consecutive patients were treated between 1984 and 2000. At 10 years 75% of men (many were low-risk) were free of recurrence, and that success rate dropped only 2% to 73% at the 15 year point, which was stable at 73% through the 25 year point. The latest recurrence was at the 15 and a half year point, and for 313 men who were treated at least 16 years before the paper was written, only 5% of recurrences were late.

    I hope this helps those of us with long life expectancies who are considering radiation as a therapy.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    22 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA, for some reason based on a less sensitive test on 7/20/2021 was <0.05, still apparently cured in my ninth year since radiation (PSA as of 12/2/2020 was <0.01). (T 93 as of 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. I have also had 225 undergraduate classroom hours just in statistics and experimental design, plus more in graduate school, which dwarfs what most doctors have, and that has made my “hard knocks” experience more meaningful. What I experienced is not a guarantee for all but shows what is possible.

    Last edited by IADT3since2000; 01-13-2022 at 08:48 PM. Reason: Grammar, spelling corrections.

     
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    Old 01-14-2022, 10:44 AM   #2
    Prostatefree
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    Re: Gaining High Confidence in Long-Term Success and Safety of Radiation for Prostate

    While it appears I am free of any significant risk of BCR five years after my surgery. My surgeon will follow me for ten years. There is enough evidence of BCR occuring up to 10 years after surgery to support this protocol in my healthcare system.

    What is the standard of care for following past patients for BCR after initial radiation treatments?
    __________________
    Born 1953; family w/PCa-grandfather, 3 brothers
    7-12-04 PSA 1.9; 7-10-06 PSA 2.0; 8-30-07 PSA 3.2; 12-1-11 PSA 5.7; 5-16-12 PSA 4.76; 12-11-12 PSA 5.2; 3-7-16 PSA 7.2
    3-14-16 TRUS biopsy, PCa 1%-60% across 8 of 12 samples, G3+3
    5-4-16 DaVinci RP, Path-65g, lymph nodes, seminal vesicles, capsule, margin all neg, upgraded to G3+4, Tumor vol 35%, +pT2c, No Incontinence-6mos, Erections-14 months
    7-9-21 PSA less than 0.02; zero club 5yrs

     
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    Old 01-14-2022, 04:53 PM   #3
    Terry G
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    Re: Gaining High Confidence in Long-Term Success and Safety of Radiation for Prostate

    I can share my followup treatment at Cleveland Clinic I don’t know if it’s the standard. For the first four years I met with a team member every six months to review my PSA. At the last virtual meeting they advised to move my PSA checks to once per year. They said that since I was a low volume Gleason 6 that I could consider myself ‘cured’ and if I had any concerns to check back anytime. In all respects I can say I have no changes in urinary, bowel, or sexual function except for a significant reduction in ejaculate. I don’t believe I could have hoped for a better outcome. Terry
    __________________
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    Bx: Three of twelve cores adenocarcinoma Gleason 6 (3+3) all on left side, no pni.
    DOB 7/21/47; good health; age 69 @ Dx
    Treated 6/17 SBRT @ Cleveland Clinic by Dr. Tendulkar
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    PSA’s post.SBRT 1.1, 1.1, .9, 1.8, 2.7, 1.0, 0.3, 0.6, 0.8, 0.4

     
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    Old 01-14-2022, 08:56 PM   #4
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    Re: Gaining High Confidence in Long-Term Success and Safety of Radiation for Prostate

    Surgery or radiation. Quite a dilemma in my view.

     
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    Old 01-15-2022, 10:49 AM   #5
    IADT3since2000
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    Re: Gaining High Confidence in Long-Term Success and Safety of Radiation for Prostate

    Hi Prostatefree. You wrote:
    Quote:
    Originally Posted by Prostatefree View Post
    ...
    What is the standard of care for following past patients for BCR after initial radiation treatments?
    First, if there are no indications of recurrence, the monitoring guidelines after treatment are the same for all risk levels and treatments, surgery or radiation, based on the guidelines for prostate cancer at nccn.org (the National Comprehensive Cancer Network, a highly respected guideline group), version 3.2022, page PROS-9:

    - Risk assessment ("risk stratification") based on PSA doubling time (PSADT),
    - PSA every 6 or 12 months, and
    - DRE every year, but may be omitted if the PSA is "undetectable" (with that term not precisely defined).

    It looks like Terry's experience was in line with this.

    My own monitoring was more attentive: no DREs, partly because the area is more fragile for a period of time after radiation, and then probably because my PSA was so low, but PSAs every three months for probably six years or so. More recently I have been tested every six months, "graduating" from the more frequent monitoring regimen. I also have been examined by my oncologist every six months after getting various blood tests (CBC, sometimes CMP, often testosterone and 25 hydroxy vitamin D). I also asked my gastroenterologist to check for rectal cancer each time I had a colonoscopy; there is some risk after radition, but it is very low.

    But if there is a recurrence based on the PSA pattern or a positive DRE, then NCCN page PROS-11 for radiation therapy recurrence describes the Trans Rectal Ultrasound (TRUS) and or bone and soft-tissue imaging for staging and subsequent assessment. Footnotes I and J describe imaging options and recommendations.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    22 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA, for some reason based on a less sensitive test on 7/20/2021 was <0.05, still apparently cured in my ninth year since radiation (PSA as of 12/2/2020 was <0.01). (T 93 as of 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. I have also had 225 undergraduate classroom hours just in statistics and experimental design, plus more in graduate school, which dwarfs what most doctors have, and that has made my “hard knocks” experience more meaningful. What I experienced is not a guarantee for all but shows what is possible.

     
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