Focused Ultrasound System Receives Go Ahead for Prostate Cancer Ablation

On October 9, 2015, the Sonablate 450, a high intensity focused ultrasound (HIFU) system for treating prostate cancer, received FDA approval. The Sonablate uses high intensity therapeutic ultrasound to heat and destroy the prostate cancer without damaging surrounding tissue.

The Sonablate allows doctors to carefully target the diseased tissue within the prostate, heating and destroying it while preserving the healthy tissue around the prostate gland. While not perfect at eliminating side effects, HIFU greatly reduces the risk of incontinence and impotence which are common after robotic prostatectomy. Also, because ultrasound does not use damaging radiation, the treatment can be repeated if needed.

Because this treatment was allowed only off­shore, many men had been traveling overseas to receive it. Now that the HIFU treatment option is FDA approved, it is available domestically.

Of course, even minimally invasive treatments carry some risk of side effects. Patients who have the very common Gleason 6 prostate “cancer” may be better off with active surveillance rather treatment since the Gleason 6 lacks the hallmarks of a cancer and is not potentially lethal. Patients must weigh the possible benefits of treatment against the potential side effects before pursuing HIFU or any other treatment option.

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Bacteriophage Provides Promise in Detecting Prostate Cancer

Most prostate cancers are slow­-growing and do not behave like a cancer at all. This is particularly so for the very common Gleason 6 “cancer” which which lacks the hallmarks of a cancer. This knowledge has lead some doctors to warn against routine prostate cancer screenings and automatic treatment. However, for men with the less common aggressive high­-grade form of the disease, early detection may be the key to their survival. Researchers in the United States may have found a way to use bacterial viruses to help sort this out.

Bacteriophage, which is harmless to humans, has a natural tendency to bond with cancer cells and detect PSMA, a prostate cancer flag for aggressive prostate cancer. However, the use of bacteriophages to detect prostate cancer was not effective initially due to the non­specific adhesion between the phage and certain cell surface receptors.

Researchers in the United States then found that wrapping the bacteriophage with the polymer PEG, it created a sphere around the phage to stop non­specific cell adhesion. This made detecting cells that that the bacteriophage had bonded to much easier and more accurate.

The goal is to create a bio­marker that will allow doctors to detect the presence of aggressive prostate cancers without invasive tests. If successful, the modified bacteriophage will link to cancer bio­markers in a simple blood test and allow doctors to distinguish between aggressive, high­grade prostate cancers which need treatment and, the Gleason 6 “cancer” which does not need treatment.

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​ Gleason 6 Prostate “Cancer”

The Gleason 6
The Gleason 3+3=6 prostate “cancer”, although called a cancer, fails to behave like a cancer. The Gleason 6 is the most commonly diagnosed prostate “cancer” and, on both clinical and molecular biology levels, the Gleason 6 “cancer” LACKS the hallmarks of a cancer.
The Gleason 6 “cancer” is NOT a health­risk, lacks lethal potential, behaves as a pseudo­cancer and, is commonly treated unnecessarily creating much more harm than good. Even the concept of “active surveillance” for the Gleason 6 requires review as this term implies that the 6 may behave as cancerous when it does not.

The charade of prostate cancer awareness month
September is a very dangerous month for men as they are more likely than at any other time of the year to become ensnared by the falsehoods, misrepresentations and fear­mongering of predatory urologists embarking on widespread indiscriminate and opportunistic PSA-­based prostate cancer screening. A self­serving and misguided “awareness” program which detects mainly the Gleason 6 “cancer” form of prostate cancer. A disease where urologists have chosen to retain the misleading cancer label to imply that the 6 has, or, may develop malignant potential similar to the less common high­grade prostate cancers when that is patently untrue. Compounding this exploitation of medical illiteracy by urologists and railroading men into getting “treatments” which have no meaningful benefits for the Gleason 6 pseudo­cancer, are the considerable risks and negative quality of life issues which you will live with the rest of your life.

Beware PSA-based screening and debilitating “treatments”
Various sources have warned about the dangers surrounding PSA-­based prostate cancer screening programs and its debilitating treatments time and time again. From noted physicians like A. Horan MD (How to Avoid the Overdiagnosis and Overtreatment of Prostate Cancer) and Otis Brawley MD (Chief Medical Officer of the American Red Cross); the endless lawsuits filed against surgeons and the device manufacturer because of the many complications associated with the robotic prostatectomy; the scores of self­reported harms listed on the FDA’s own product safety system, MAUDE (Manufacturer and User Facility Device Experience) ­ representing only about 8% of actual adverse events; the warnings issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight agency to, the robot device makers themselves who clearly recognize the dangers associated with the robotic prostatectomy as their device disclaimers are getting longer with each revision. In essence, the treatment harms outweigh any benefits and, are commonly worse than the disease itself.

Grade creep and the evolution of Gleason 6 grading and scoring
In 1978, the American Cancer Society recognized the Gleason scoring system where the primary and secondary prostate cancer grades were arbitrarily scored 1­5 under the low power microscope and then these two grades added to create a Gleason score. Most prostate cancers were diagnosed as the Gleason 3 (1 out of 5 primary pattern) + 3 (1 out of 5 secondary pattern) = 6. In 2005, Gleason scores of 5 or less were no longer considered carcinoma and, by redefining certain pathological features previously assigned to the Gleason pattern 3, were now assigned to patterns 4 or 5. This arbitrary reclassification has resulted in an upgrading and an increase in the Gleason 7s category (3+4 and 4+3). In effect, today’s Gleason 3+4=7 is similar to yesterday’s Gleason 6. In fact, despite this arbitrary redefining of certain pattern features previously assigned to the Gleason 3 pattern, it is quite evident that the Gleason 3+4=7 BEHAVES like the NON health­risk Gleason 6. This fact is especially important in light of the misleading talk of possible upgrading which can be seen at times in those unfortunate enough to have been subjected to the toxic robotic prostatectomy. Most of these so­called upgrades involving the 6 however, are to the Gleason 3+4 which behaves as the Gleason 6 pseudo­cancer and, simply reflect the randomness of prostate needle biopsies and the observer error seen with pathologists.

Decreasing prostate cancer treatment risks and improving benefits
Soon, the mp­MRI imaging of the prostate (in experienced hands) will be refined enough to be able to detect and diagnose just the meaningful high­-grade prostate cancers, dispense with the risky, random prostate needle biopsy, the subjectivity issues and observer errors associated with pathologists and, stop all the unnecessary treatments of the Gleason 6 pseudo­cancer employing the scientifically unproven robotic prostatectomy. Only the less common but important high­grade prostate cancers will be detected and then treated as an outpatient using MRI­-guided focal HIFU or laser therapy at the same sitting.

Finally, The Gleason 6 disease has very questionable significance and the detection and treatment of the Gleason 6 should be severely curtailed in order to stop the terrible consequences of debilitating treatments such as the robotic prostatectomy. The gross generalization and marketing of the all­inclusive prostate cancer label to infer that all prostate cancers have lethal potential or, could progress to become lethal, is a flagrant lie. Only, the less common high­-grade prostate cancers are potentially lethal and, greater than 50% of men dying from high­-grade prostate cancer are diagnosed at age 75 years or older. Therefore, the best awareness you could practice in order to preserve your health and quality of life is to stay away from self-­serving PSA-­based screening programs as well as those misinformed patients fooled into believing they are survivors. They are simply survivors of a “treatment” and not their Gleason 6 which never was a real cancer.

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PROSTATE CANCER UPGRADING: more fear­mongering

Prostate cancer upgrading means that a prostate cancer grade and score (or measure of prostate cancer aggressiveness) found in a surgically removed prostate gland can, sometimes, be of a higher grade than diagnosed in the initial needle biopsy of the prostate. This so­called upgrading phenomenon is marketed by urologists to imply that prostate cancer upgrading is a likely significant event and that most prostate cancers are worse than the needle biopsy suggests. This gross misrepresentation is designed to push men into seeking treatments when any treatment is often unnecessary. Unnecessary, because even though the ubiquitous Gleason 3+3=6 is called a “cancer”, this “cancer”, fails to behave like a cancer.

What are the facts about prostate cancer upgrading?
> the grade and score of the prostate cancer as estimated by pathologists in the surgically removed specimen can be the same or, even of a lower grade than estimated in the initial needle biopsy of the prostate
> the most common upgrade (if it occurs) is the Gleason 3+4=7 score which in reality, behaves similar to the non health­risk Gleason 3+3=6 prostate pseudo­cancer
> less common is an upgrading of the prostate cancer to a Gleason 4+3

Therefore, rather than sensationalizing and misrepresenting how prostate cancers may be underestimated at initial presentation, the reality is that most prostate cancer upgrades are insignificant if they occur at all. In fact, you are far more likely to be mislead by your urologist into having an unnecessary debilitating treatment than having your life “saved” from an unlikely significant upgrade. Furthermore, the USPSTF has concluded already, that the risks of PSA­based screening, evaluation and treatments for most prostate cancers far outweigh the perceived benefits.

Prostate cancer upgrading represents mostly the problem of observer error and subjective interpretation issues amongst pathologists reviewing your pathology. To a lesser degree, the sampling error associated with the needle biopsy of your prostate may add to the issue. Therefore, before considering any treatment you should obtain several pathology opinions from pathologists well versed in prostate pathology so that you may form a consensus from these opinions. Additionally, certain biomarker studies may allow an assessment of the biological potential of your pathology and or, you may undertake an mp­MRI with a radiologist experienced in prostate cancer MRI imaging. This mp­MRI imaging is especially attractive since it appears to identify only the important high­grade prostate cancers which demand treatment and ignores the non health­risk Gleason 3+3=6 pseudo­cancer which does not require treatment. Also, should you have a small, high­grade prostate cancer which was missed on your needle biopsy, expert monitoring will detect it in a timely fashion to allow focal therapy.

The sensationalizing of prostate cancer “upgrading” comes hard on the heels of a long line of reprehensible scare tactics and half­truths marketed by the prostate cancer industry. All of these many misrepresentations are designed to give you the impression that you are dealing with a disease worse than it is or, has the potential to progress quickly.

For example:
> urologists calling the most common prostate cancer, a “cancer” when it behaves as noncancerous. In fact, the very common Gleason 3+3=6 prostate “cancer” LACKS the hallmarks of a cancer on both clinical and molecular biology grounds. It is a pseudo­cancer, is not a health­risk and does not progress.

> grade “creep”. This represents mostly grade inflation and subjective interpretation errors on the part of pathologists reviewing the initial prostate needle biopsy sample. In other words, some pathologists are assessing a higher grade to your prostate cancer in the needle biopsy than actually exists or, they are assigning higher grades to the same disease compared to what they did in the past. This issue is similar to prostate cancer “upgrading” but whereas “creep” is an inflated grade based upon your initial biopsy the so­called upgrade is inferring that the cancer grade found in your surgically removed prostate is greater than was originally believed from your initial needle biopsy sample. Both “creep” and “upgrade” are used to mislead you into getting treatment or, have you believe that you made a good choice after undergoing a debilitating treatment.

> inflating the incidence and significance of most prostate cancers. Men do not die from the Gleason 3+3=6 prostate pseudo­“cancers”. In fact, only 3% of all men with a prostate cancer label in the US will die from their disease but, only if they have the high­grade form of the disease. Unfortunately, the misrepresentations about prostate cancer and the toxic radical prostatectomy treatment will cause an additional 3,000 deaths within 30 days of this misguided surgery each year because of its many complications, according to A. Horan MD, “The Big Scare. The Business of Prostate Cancer”.

> implying that the FDA approval for the robotic assisted radical prostatectomy was based upon scientific studies involving prostate cancer when this FDA approval for the robotic assisted radical prostatectomy was based upon low­level gallbladder and Nissen fundoplication studies only. In fact, the fraudulent approval of radical surgery/robotic prostatectomy comes with more false hope and complications than for any other cancer operation.­content/uploads/BEWARE­BEWARE­FDA­_APPROVE D_­ROBOTIC­PROSTATECTOMY­CARE­1.pdf

In addition to these gross misrepresentations by urologists have been a slew of underhanded and reprehensible actions on their part attempting to influence and undermine Government oversight agencies such as the FDA and the USPSTF. As well, there was the egregious torpedoing of the minimally invasive HIFU application by FDA urology panelists attempting to protect their radical prostatectomy franchise. es/MedicalDevicesAdvisoryCommittee/Gastroenterology­UrologyDevicesPanel/UCM420537.pdf

Also, there was the unconscionable influencing of Senate Staff attempting to capitalize on their medical illiteracy and, through a National Prostate Cancer Council, have them initiate a pushback on the USPSTF so urologists can continue their self­serving but misguided PSA­based screening for prostate cancer. A prostate cancer screening program which has a much greater probability of causing harm than from the remote possibility of saving a life.­times/news/prostate­cancer­council­bil l­earns­aua­support?page=full

Finally, more and more men are wise to the fact that the common Gleason 3+3=6 “cancer” is not a health­risk, grossly overtreated and, should NOT be called a cancer. However, to counter a potential drop off in patient traffic, urologists are engaging in all sorts of prostate cancer misrepresentations such as “upgrading”. This egregious fear­mongering ploy is designed simply to spook men into having prostate cancer treatments they never needed and, afterwards, fooling them into thinking they were survivors when they were only survivors of a debilitating treatment.­prostate­cancer­surgery­a­public­health­nightmare/

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Study Finds MRI Accurate Predictor of Low­Risk Prostate Cancer

Is watchful waiting the best choice for prostate cancer patients? According to a recent study from the Memorial Sloan­Kettering Cancer Center in New York City, published in the J​ournal of Urology,​prostate MRI testing can help doctors decide whether or not this less invasive option is the right way to approach a low­risk prostate cancer patient. This was the first time the ability of an MRI to predict confirmatory biopsy results had been examined.
In the study, 388 men who were recently diagnosed with low­risk prostate cancer were given an endorectal MRI. Radiologists then reviewed the MRI and assigned it a score. Then, the patients’ biopsy results were studied. Patients who had a low imaging score from an endorectal MRI had a greater than or equal to 95 percent negative predictive value and specificity for upgrading on biopsy. For those with a higher score, 90 percent had a correlation with upgrading.

Prostate cancer, when it is not growing or aggressive, is a very low risk disease. In fact,
many forms of prostate cancer do not behave like cancers at all, and as such do not need aggressive treatments.​Watchful waiting, therefore, allows doctors to keep tabs on the tumors and determine when they need further treatment, if they ever do.

What does this data mean? This study shows that MRI can be an affective tool for the initial assessment of a patient to determine whether a watchful waiting approach is a safe course of action. Because watchful waiting requires identifying patients who have low­risk disease, this is valuable information. Tumor visualization of high­grade disease only using MRI allows for a targeted prostate biopsy. MRI may help contribute to the assessment process in determining whether a patient is a candidate for a watchful waiting approach or focal therapy.

This is important information because so many newly diagnosed prostate cancer patients are over­treated. The National Comprehensive Cancer Network also recommends watchful waiting as a treatment option for patients who have low­risk disease. When the life expectancy of the patient is at least 10 years, the risks and quality of life issues created by treating can often be worse than the tumors themselves.

While further research may be forthcoming, this shows, again, the fact that prostate cancer does not behave like a typical cancer, and as a result should be treated less aggressively until proven that it needs an aggressive treatment to prolong and save a patient’s life.

Read More >

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MRI May Reduce Need for Prostate Biopsy

Prostate biopsies are one of the only ways to predict an aggressive cancer, but they are painful, inconvenient and somewhat inaccurate. A report from Dr. Ahmed Haddad, fellow at the University of Texas Southwestern Medical Center in Dallas, presented at the American Urological Association annual meeting showed that multiparametric MRI scans following a suggestive PSA test or digital rectal exam could reduce the need for a biopsy while still providing an accurate prediction for prostate cancer patients.

In his report, Dr. Haddad and his colleagues found a 73 percent reduction in the need for a biopsy when using the multiparametric MRI scan, identifying fewer potential cancers and requiring fewer biopsies as a result. Interestingly, the cost for MP­MRI is slightly lower than at transrectal ultrasound­guided biopsy. However, the study also found that the MP­MRI missed a few cancers, identifying 16 cancers for every 100 men compared to 20.4 cancers out of 100 men for the biopsy.

In deciding the best way to treat prostate cancer, doctors must weigh the risks of treatment, including its affect on quality of life for patients, against the potential benefit and life­saving capabilities of treatment. Because so m​any prostate tumors do not behave like typical cancers, and do not pose a risk to the patient’s life,​urologists are constantly looking for ways to better predict the outcome of a particular cancer. This particular study showed the potential for the use of MRI technology to identify cancers even without the use of a biopsy.
According to Dr. Haddad, the study was successful in determining that MP­MRI was able to reduce the number of prostate biopsies for patients in a cost equivalent way. However, he did state that further study was needed to determine the clinical significance of the cancers missed by the MRI. As an initial study, it shows promise, and further study in the future will help determine whether this can be an effective diagnostic choice.

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MRI Guidance for Prostate Biopsies Increases Chances of Finding Aggressive Cancers

Traditionally, biopsies to detect prostate cancers rely on ultrasound guidance but a recent study published through the Washington University School of Medicine in St. Louis indicates that MRI may be a more accurate technology. Presented on May 19 at the American Urological Association meeting in Orlando, Florida, the research found a direct correlation between more accurate prostate biopsies and the use of MRI technology to guide the placement of needles.

Patients who are in a watchful waiting therapy for prostate cancer typically are given a biopsy when their PSA number rises above 4.0 ng/ml. This rise in PSA levels may indicate a growth in the tumors, and biopsies can help predict how aggressive the cancer is becoming. However, ultrasound technology cannot visualize tumors well, so urologists will randomly biopsy the prostate gland to gather tissue samples. This random process leads to a higher risk of a false negatives because the needle may have missed areas of cancer.
In the Washington University study, Dr. Gerald Andriole and radiologists from the Mallinckdrodt Institute of Radiology used MRI scans of the prostate to biopsy 70 men with PSA scores of just above 8.0 ng/ml, on average. Dr. Andriole took tissue samples from those areas that looked suspicious on the MRI, as well as any areas where the MRI was not able to visualize well . H​is results showed that these targeted biopsies were nearly three times as effective at finding cancer than non­targeted biopsies.​In addition, they were four times more likely to detect aggressive tumors effectively, and therefore order treatment only for patients who had this disease.

The study was not perfect, however. Dr. Andriole noted that the process predicted positive biopsies around 62 percent of the time. Researchers believe, however, that improvements in MRI technology may make it an even more viable option for prostate cancer screening, allowing doctors to rule out the need for a biopsy when the MRI result is negative.

Read More >­prostate­cancer­surgery­a­public­health­nightmare/

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A Look at the Status of Focal Therapy Treatments for Prostate Cancer

At the American Urological Association’s Annual Meeting held in May of 2015 in New Orleans, Peter A. Pinto presented information highlighting the current status of focal therapies for prostate cancer. According to the report, over 27,500 men were estimated to die from prostate cancer in 2015, pointing to the need for a more effective and definitive therapy for their treatment. Because of the potential harm of whole­gland treatment, including the risk of incontinence and impotence, MRI­guided focal therapy and MRI­focal ablation as a treatment for prostate cancer is growing in popularity, both with patients and physicians.
Focal ablation uses energy from a variety of sources, including high­intensity focused ultrasound (HIFU), photodynamic therapy, lasers, and cryotherapy, to destroy the cancer inside the prostate gland. Focal laser ablation was the focus of the report at the AUA meeting as this treatment is compatible with MRI scanning and doctors can localize precisely the areas they are targeting and protect the surrounding soft tissues.
According to the report, clinical trials on 12 patients at the University of Chicago found minor adverse affects to the laser treatment. Patients had no significant changes in IPSS and SHIM scores, while 8 patients had no tumors at the ablation site. Two patients had contralateral Gleason 6 and four patients had residual disease. A repeat study with 15 patients at the National Cancer Institute found similar results. In the second study, 13 patients had no tumors while 2 patients had residual disease, one with G6.
This study points to the potential benefit of focused laser ablation to effectively treat prostate cancer while protecting the quality of life of the patients. Further study as to the effectiveness of the treatment is needed.

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Focal Therapy and Image­Guided Treatment the Future of Prostate Cancer Treatment

At the 2015 European Congress of Radiology, Dr. Hashim Ahmed, senior lecturer at the University College London, presented data on his results using HIFU to treat over 500 men with prostate cancer. According to his results, this treatment, and other treatments that target the cancer rather than the entire gland, have excellent results.

Traditionally, men with aggressive prostate cancers are treated by destroying or surgically removing the entire gland. While this can effectively remove the cancer, it is damaging to the patient’s overall quality of life, causing significant harm and removing part of the body that may not need to be removed. In fact, at the best treatment centers, over half of patients suffered from erectile dysfunction after prostatectomy. This prompted Dr. Ahmed to study focal therapy as a way to treat prostate cancer while preserving quality of life.
In his research, Dr. Ahmed treated over 500 patients with prostate cancer using high­intensity focused ultrasound (HIFU) through trials or in his clinical practice. At a median follow up of three years, he had a 100 percent survival rates. Just 0.5 percent of the patients required salvage therapy, and redo rates were 13.6 and 18.6 percent. Metastasis­free survival rates were over 99 percent for the patients as well.
Focal treatments, like HIFU, allow doctors to target only those areas of the prostate gland that actually need treatment. Instead of treating the entire gland or all areas of cancer, doctors can treat only those areas that are aggressively growing. Doctors can even treat one cancer area, which is identified as aggressive, while leaving a smaller area alone for active surveillance. This improves survival rates while protecting quality of life.
Improved imaging, including improvements in MRI, are helping doctors be more confident when choosing these treatments and following patients through active surveillance. This, in turn, is lowering the number of unnecessary procedures and doctors work with patients to preserve quality of life while living with prostate cancer.

Dr. Ahmed and his colleagues are convinced that image­guided therapies, like HIFU, are the future of prostate cancer treatment, allowing for good cancer control, retained potency, retained continence and a much better quality of life.

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B​ert Vorstman MD, MS, FAAP, FRACS, FACS w​
The robotic prostatectomy is probably associated with more complications than any other surgical procedure. Furthermore, it is the only procedure where its many complications will also impact your spouse/partner and, commonly lifelong.
The following will let you understand why the robotic prostatectomy and its many complications is not for you.
> the dangers of the robotic prostatectomy are clearly evident from a Google search by the endless lawsuits filed against surgeons and the robot device manufacturer
> the scores of self­reported harms listed on the FDA’s own product safety system, MAUDE (Manufacturer and User Facility Device Experience) ­ representing only about 8% of actual adverse events
> the warnings issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight agency and that the harms of PSA­based prostate cancer screening and treatment outweigh any benefits
> the many warnings from a number of physicians and organizations
> the robot makers themselves who clearly recognize the device dangers for radical prostatectomy as their disclaimers are getting longer with each revision
These many warnings about​the dangers of the robotic prostatectomy are even more egregious when you also realize that:
> the FDA urology panelists approved fraudulently, the robotic device as safe and effective for use in the radical prostatectomy on the basis of some low­level and irrelevant gallbladder studies only and, without a single case of prostate cancer being included in that trial
> the AUA labelled the radical prostatectomy as “standard” for treating the common Gleason 3+3=6 “cancer” which LACKS the very hallmarks of a cancer. In essence, many men are treated for a disease which needs no treatment, undergo surgery with a scientifically unproven device and, are often left limp and leaking
> 2­3% of ALL men diagnosed with prostate cancer will die from their disease but only if they have high­grade prostate cancer. The Gleason 3+3=6 is NOT a health risk
Read More about the many Robotic Prostatectomy Complications >­prostatectomy­complications/

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