The Lancet Oncology, Early Online Publication, 1 July 2010
Mortality results from the Göteborg randomised population-based prostate-cancer screening trial
Original TextProf Jonas Hugosson MD a , Sigrid Carlsson MD a, Gunnar Aus MD a, Svante Bergdahl MD a, Ali Khatami MD a, Pär Lodding MD a, Carl-Gustaf Pihl MD c, Johan Stranne MD a, Erik Holmberg PhD b, Hans Lilja MD d e
Summary
Background
Prostate cancer is one of the leading causes of death from malignant disease among men in the developed world. One strategy to decrease the risk of death from this disease is screening with prostate-specific antigen (PSA); however, the extent of benefit and harm with such screening is under continuous debate.
Methods
In December, 1994, 20 000 men born between 1930 and 1944, randomly sampled from the population register, were randomised by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years (n=10 000) or to a control group not invited (n=10 000). Men in the screening group were invited up to the upper age limit (median 69, range 67—71 years) and only men with raised PSA concentrations were offered additional tests such as digital rectal examination and prostate biopsies. The primary endpoint was prostate-cancer specific mortality, analysed according to the intention-to-screen principle. The study is ongoing, with men who have not reached the upper age limit invited for PSA testing. This is the first planned report on cumulative prostate-cancer incidence and mortality calculated up to Dec 31, 2008. This study is registered as an International Standard Randomised Controlled TrialISRCTN54449243.
Findings
In each group, 48 men were excluded from the analysis because of death or emigration before the randomisation date, or prevalent prostate cancer. In men randomised to screening, 7578 (76%) of 9952 attended at least once. During a median follow-up of 14 years, 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer, resulting in a cumulative prostate-cancer incidence of 12·7% in the screening group and 8·2% in the control group (hazard ratio 1·64; 95% CI 1·50—1·80; p<0·0001). The absolute cumulative risk reduction of death from prostate cancer at 14 years was 0·40% (95% CI 0·17—0·64), from 0·90% in the control group to 0·50% in the screening group. The rate ratio for death from prostate cancer was 0·56 (95% CI 0·39—0·82; p=0·002) in the screening compared with the control group. The rate ratio of death from prostate cancer for attendees compared with the control group was 0·44 (95% CI 0·28—0·68; p=0·0002). Overall, 293 (95% CI 177—799) men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death.
Interpretation
This study shows that prostate cancer mortality was reduced almost by half over 14 years. However, the risk of over-diagnosis is substantial and the number needed to treat is at least as high as in breast-cancer screening programmes. The benefit of prostate-cancer screening compares favourably to other cancer screening programs.
Funding
The Swedish Cancer Society, the Swedish Research Council, and the National Cancer Institute
Thursday, July 8, 2010
Tuesday, July 6, 2010
THE ADVANTAGES OF HIFU
Great article in the WSJ on the University of Gothenburg's findings on the value of PSA to be more sensitive that in screening for other types of common cancers, such as breast and colon cancer. The facts are: 1) PSA is the most precise and sensitive of all tumor markers. 2) Prostate cancer is the most common cancer in men. 3) Prostate cancer is the second most common cancer in men. 4) If detected early, it's curable. The conclusion of the Gothenburg research: PSA screening and treatment can reduce the risk of death from prostate cancer by as much as 50%.
The real challenge for men is when it comes to choosing a treatment. There lies the real issue, in that among physician worldwide, there is no general consensus as to the optimal treatment. Instead, treatment recommendations are a bias of the specialty and the training of the treating physician: surgeons will recommend surgery, and radiation oncologist radiation. As the saying goes: "to hammer everything looks like a nail." Likewise, is the bias when it comes to treating prostate cancer. The latest craze is the Robotic prostatectomy! However, most recent evidence shows that Robotic prostatectomy has a higher risk of recurrence and no better clinical outcomes in the incidence of impotence and urinary incontinence. After all, it's still the same human hands directing the Robotic instruments.
Other unique characteristic about prostate cancer is that the standard treatments available come with a high risks of complications. Particularly in quality of life matters such as greater than 50% incidence of impotence and 10-20 % risk of urinary incontinence associated with surgical removal of the prostate. There are similar risks with radiation. Plus a high risk of developing a secondary cancer from the exposure to the radiation. These issues are so concerning to men, that they often elect on "watchful waiting" or "active surveillance" at the risk of progression of cancer and metastasis... another unique characteristic of prostate cancer. I certainly know of no malignancy where a patient would consider opting for no treatment at the risk of death.
For the past 7 years I have offered High Intensity Focused Ultrasound or HIFU to patients with localized prostate cancer. The technology has been approved in Europe and other countries since 1998, and currently is approved worldwide, except in the U.S. However, American urologist have embraced the procedure and travel with their patients to treat them in countries where it is approved. Another unique characteristic of prostate cancer: American urologist and their patients are willing to travel outside the U.S. in order to perform and receive this very advanced futuristic treatment. But this is not really unique, as Americans are familiar with seeking health care outside the U.S. while procedures and medications are pending FDA approval.
The principle advantage to HIFU is that there are less risk of impotence and incontinence: the two most dreaded potential complication feared by men. Clinical efficacy of HIFU in recent years has proven post treatment PSA (PSA Nadir) of the same range as surgical removal or radiation therapy. To the skeptics, the initial impression is that the whole thing is too good to be true. But it is that good, in efficacy of treatment, and less risk of complications. Otherwise, the FDA would not have allowed the clinical trials to progress from Phase I and II, to current phase III. Another interesting bit of information: None of the "standard" treatments available for treating prostate cancer was ever FDA approved, nor did any of them undergo any type of clinical trial. Instead they were "grand- fathered" as treatments that were used prior to more rigorous FDA regulation came into place.
The Gothenburg study will undoubtedly influence the application of PSA screening by both physician's use and patient's request. Unfortunate, this will lead to the potential risk of overtreatment and increase number of patients at risk of compromised quality of life. The American Cancer Society reports approximately 250,000 new cases of prostate cancer per year. Increase screening, as well longer living population, will lead to more patients diagnosed with prostate cancer. Potentially doubling the number of newly diagnosed patients per year. As well as creating a huge economic burden, if not a crisis in the cost of healthcare. The cost of treatments does vary, with radiation being the most costly. The cost of a HIFU treatment is significantly less than all standard treatments. In Addition, as an outpatient procedure, it allows the patient to return to work and other routine activities the day after treatment is a plus for patient convenience as well as lost of revenue and productivity.
How likely is HIFU to get FDA approval? Having personally performed over 2,000 cases, and trained hundreds of urologist from around the world, I am confident that HIFU will be approved. It just a matter of the time it takes to complete the trials. What impact will HIFU have as a treatment option for prostate cancer? Several Biomedical Wall Street analysts and industry newsletters predict a 91% compounded yearly growth over the next five years, with HIFU becoming the most common treatment for prostate cancer by 2015. I never imagined a four letter word would impact healthcare so positively and so powerfully. But it has happened before. I remember the huge incisions we made to remove tiny kidney stone, the ensuing pain and days of recovery. Sometimes resecting ribs and injuring adjacent tissue and whole organs. Then there came another four letter word: ESWL, (extracorporael shock wave lithotripsy) and no more opened surgery for kidney stones. ESWL was approved by the FDA in 1884. Interestingly, the science and technology of ESWL is the same as for HIFU. It's called piezoelectric energy. How big is HIFU as an available treatment for the most common cancer in men, and the second most common cause of death related to cancer versus the impact of ESWL? Kidney stone affects a small number of Americans, and patients typically don't die from kidney stones.
George M. Suarez, M.D. F.A.C.S.
Board Certified Urologist
305-595-0199
9195 Sunset Dr. Suite 110
Miami, Florida
www.hifumedicalexpert.com
The real challenge for men is when it comes to choosing a treatment. There lies the real issue, in that among physician worldwide, there is no general consensus as to the optimal treatment. Instead, treatment recommendations are a bias of the specialty and the training of the treating physician: surgeons will recommend surgery, and radiation oncologist radiation. As the saying goes: "to hammer everything looks like a nail." Likewise, is the bias when it comes to treating prostate cancer. The latest craze is the Robotic prostatectomy! However, most recent evidence shows that Robotic prostatectomy has a higher risk of recurrence and no better clinical outcomes in the incidence of impotence and urinary incontinence. After all, it's still the same human hands directing the Robotic instruments.
Other unique characteristic about prostate cancer is that the standard treatments available come with a high risks of complications. Particularly in quality of life matters such as greater than 50% incidence of impotence and 10-20 % risk of urinary incontinence associated with surgical removal of the prostate. There are similar risks with radiation. Plus a high risk of developing a secondary cancer from the exposure to the radiation. These issues are so concerning to men, that they often elect on "watchful waiting" or "active surveillance" at the risk of progression of cancer and metastasis... another unique characteristic of prostate cancer. I certainly know of no malignancy where a patient would consider opting for no treatment at the risk of death.
For the past 7 years I have offered High Intensity Focused Ultrasound or HIFU to patients with localized prostate cancer. The technology has been approved in Europe and other countries since 1998, and currently is approved worldwide, except in the U.S. However, American urologist have embraced the procedure and travel with their patients to treat them in countries where it is approved. Another unique characteristic of prostate cancer: American urologist and their patients are willing to travel outside the U.S. in order to perform and receive this very advanced futuristic treatment. But this is not really unique, as Americans are familiar with seeking health care outside the U.S. while procedures and medications are pending FDA approval.
The principle advantage to HIFU is that there are less risk of impotence and incontinence: the two most dreaded potential complication feared by men. Clinical efficacy of HIFU in recent years has proven post treatment PSA (PSA Nadir) of the same range as surgical removal or radiation therapy. To the skeptics, the initial impression is that the whole thing is too good to be true. But it is that good, in efficacy of treatment, and less risk of complications. Otherwise, the FDA would not have allowed the clinical trials to progress from Phase I and II, to current phase III. Another interesting bit of information: None of the "standard" treatments available for treating prostate cancer was ever FDA approved, nor did any of them undergo any type of clinical trial. Instead they were "grand- fathered" as treatments that were used prior to more rigorous FDA regulation came into place.
The Gothenburg study will undoubtedly influence the application of PSA screening by both physician's use and patient's request. Unfortunate, this will lead to the potential risk of overtreatment and increase number of patients at risk of compromised quality of life. The American Cancer Society reports approximately 250,000 new cases of prostate cancer per year. Increase screening, as well longer living population, will lead to more patients diagnosed with prostate cancer. Potentially doubling the number of newly diagnosed patients per year. As well as creating a huge economic burden, if not a crisis in the cost of healthcare. The cost of treatments does vary, with radiation being the most costly. The cost of a HIFU treatment is significantly less than all standard treatments. In Addition, as an outpatient procedure, it allows the patient to return to work and other routine activities the day after treatment is a plus for patient convenience as well as lost of revenue and productivity.
How likely is HIFU to get FDA approval? Having personally performed over 2,000 cases, and trained hundreds of urologist from around the world, I am confident that HIFU will be approved. It just a matter of the time it takes to complete the trials. What impact will HIFU have as a treatment option for prostate cancer? Several Biomedical Wall Street analysts and industry newsletters predict a 91% compounded yearly growth over the next five years, with HIFU becoming the most common treatment for prostate cancer by 2015. I never imagined a four letter word would impact healthcare so positively and so powerfully. But it has happened before. I remember the huge incisions we made to remove tiny kidney stone, the ensuing pain and days of recovery. Sometimes resecting ribs and injuring adjacent tissue and whole organs. Then there came another four letter word: ESWL, (extracorporael shock wave lithotripsy) and no more opened surgery for kidney stones. ESWL was approved by the FDA in 1884. Interestingly, the science and technology of ESWL is the same as for HIFU. It's called piezoelectric energy. How big is HIFU as an available treatment for the most common cancer in men, and the second most common cause of death related to cancer versus the impact of ESWL? Kidney stone affects a small number of Americans, and patients typically don't die from kidney stones.
George M. Suarez, M.D. F.A.C.S.
Board Certified Urologist
305-595-0199
9195 Sunset Dr. Suite 110
Miami, Florida
www.hifumedicalexpert.com
Friday, July 2, 2010
JUMP LINE - DADE COUNTY ASSOCIATION OF FIREFIGHTERS APRIL- JUNE 2010 Vol.29.No.2
ALTERNATIVE TREATMENT
By
F F Jim Bruce
PROSTATE CANCER is the most common cancer in men and the second leading cause of cancer related deaths. If detected early, it can be successfully treated using one or more of the accepted treatment options. Options are: radiation, proton beam, radical, robotic, and cryostherapy. All of these treatment have had success in destroying the cancer. Unfortunately, all of these treatments have high incidences of collateral damage. Incontinence, impotence, and recurrence are fairly common and are of great concern for patients after the procedure. Several of our brothers have had to be treated for prostate cancer and they have used more than one of the above treatments. The side effects can be as devastating to the patient as the cancer. Once the cancer is resolved, which of these treatments will allow us to return to a normal life as quickly as possible? For this reason, I write this article.
I have witnessed the devastating effects the robotic treatment had on one of our brothers and would like to tell all of you, so you can pass it on to a family member or friend. There is a treatment that is available but is not widely known about. That treatment is High Intensity Focused Ultrasound (HIFU). Although HIFU has not yet been approved by the FDA, it has been approved and is currently being used in every other developed country in the world. In fact, HIFU is the ONLY prostate cancer treatment that has ever had to undergo FDA Clinical Trials. All other available treatment options in the U.S. have been “grandfathered” in. I guess you can say that HIFU is a victim of timing!
I want you to know about HIFU because it has provided several of our brothers with remarkable results. These brothers are returning to a full and fulfilling life very quickly with minimal or no issues. I have not mentioned any names because, in this format I believe it would be inappropriate.
All of the guys, that had HIFU, are extremely happy and are willing to speak to anyone that might have questions. The brother that had the robotic treatment asked me to get this message our because of my relationship with the Doctor that started HIFU. He wishes someone had told him about this procedure so he would have had information about all the different options available, I am not saying there will never be a negative side effect with this procedure. The guys that have had it done tell me they have experienced no negative side effects. As a person that plays the odds, this would be the procedure for me and this is the procedure I would direct my family towards.
U.S. citizens have to go to either Nassau, Mexico, or Canada to have this procedure done. Do not let that scare you. These facilities are top of the line and a Doctor from the U.S. will be there to do the procedure. In years past, the patient had to absorb the entire cost for this procedure. Currently, many insurance companies, including Dade County Fire Fighters Insurance Trust, are paying some or all of the cost for this procedure.
Dr. George M. Suarez is the founder of USHIFU and has treated over two thousand men, including several of our own. He will be conducting seminars May 12, August 11, and October 19, 2010 at the Biltmore Hotel in Coral Gables, where he will be discussing all treatment options. He will be available to speak to you individually. He is a personal friend of mine, who is helping our brothers, and I wish to let as many people know about this seemingly wonderful procedure.
If you have any questions, call me: Jim
By
F F Jim Bruce
PROSTATE CANCER is the most common cancer in men and the second leading cause of cancer related deaths. If detected early, it can be successfully treated using one or more of the accepted treatment options. Options are: radiation, proton beam, radical, robotic, and cryostherapy. All of these treatment have had success in destroying the cancer. Unfortunately, all of these treatments have high incidences of collateral damage. Incontinence, impotence, and recurrence are fairly common and are of great concern for patients after the procedure. Several of our brothers have had to be treated for prostate cancer and they have used more than one of the above treatments. The side effects can be as devastating to the patient as the cancer. Once the cancer is resolved, which of these treatments will allow us to return to a normal life as quickly as possible? For this reason, I write this article.
I have witnessed the devastating effects the robotic treatment had on one of our brothers and would like to tell all of you, so you can pass it on to a family member or friend. There is a treatment that is available but is not widely known about. That treatment is High Intensity Focused Ultrasound (HIFU). Although HIFU has not yet been approved by the FDA, it has been approved and is currently being used in every other developed country in the world. In fact, HIFU is the ONLY prostate cancer treatment that has ever had to undergo FDA Clinical Trials. All other available treatment options in the U.S. have been “grandfathered” in. I guess you can say that HIFU is a victim of timing!
I want you to know about HIFU because it has provided several of our brothers with remarkable results. These brothers are returning to a full and fulfilling life very quickly with minimal or no issues. I have not mentioned any names because, in this format I believe it would be inappropriate.
All of the guys, that had HIFU, are extremely happy and are willing to speak to anyone that might have questions. The brother that had the robotic treatment asked me to get this message our because of my relationship with the Doctor that started HIFU. He wishes someone had told him about this procedure so he would have had information about all the different options available, I am not saying there will never be a negative side effect with this procedure. The guys that have had it done tell me they have experienced no negative side effects. As a person that plays the odds, this would be the procedure for me and this is the procedure I would direct my family towards.
U.S. citizens have to go to either Nassau, Mexico, or Canada to have this procedure done. Do not let that scare you. These facilities are top of the line and a Doctor from the U.S. will be there to do the procedure. In years past, the patient had to absorb the entire cost for this procedure. Currently, many insurance companies, including Dade County Fire Fighters Insurance Trust, are paying some or all of the cost for this procedure.
Dr. George M. Suarez is the founder of USHIFU and has treated over two thousand men, including several of our own. He will be conducting seminars May 12, August 11, and October 19, 2010 at the Biltmore Hotel in Coral Gables, where he will be discussing all treatment options. He will be available to speak to you individually. He is a personal friend of mine, who is helping our brothers, and I wish to let as many people know about this seemingly wonderful procedure.
If you have any questions, call me: Jim
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