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High hopes for HIFU

By Dale Kiefer

A potentially superior new technology for the non-invasive treatment of prostate carcinoma and other cancers is gaining increasing acceptance abroad. But the United States lags behind European and Asian countries in pursuing this cutting-edge procedure, despite the fact that U. S. scientists played a key role in developing the technology.

HIFU, or high-intensity focused ultrasound, ingeniously expands upon familiar ultrasound imaging technology, in much the same way that a carefully positioned magnifying glass concentrates scattered sunlight into a tight beam capable of incinerating flammable objects. By increasing the energy of ultrasound waves, and focusing them into a carefully concentrated beam, HIFU-trained clinicians are capable of destroying cancerous cells while leaving healthy tissue intact. The non-, or minimally-invasive technology allows for the complete destruction of contained (non-metastasized) soft-tissue tumors without the need for potentially risky chemotherapy, radiation, or invasive surgery. In essence, HIFU enables physicians to “burn out” internal tumors from outside the body, without harming overlying skin or adjacent healthy connective tissue.

Used for more than a decade to treat prostate and cervical cancers in Europe and Asia, this promising technology is unavailable to Americans in their own country. Only patients with the motivation and financial resources to travel out of the country for treatment – and pay fully out-of-pocket – may currently take advantage of this promising new technology. Although HIFU was pioneered in Indianapolis, in the heart of these United States, the U. S. Food and Drug Administration has so far failed to approve the procedure for the treatment of cancer by U.S. physicians. HIFU is, however, approved for the treatment of benign uterine fibroids in the U. S. This is especially good news, as current treatment options for this common condition include removal of the womb (i.e. hysterectomy); a radical option that forces many premenopausal women into surgically-induced menopause long before their time. It is hoped that as HIFU gains acceptance it may replace, or even eliminate the need for hysterectomies. Additionally, the company responsible for developing HIFU as a treatment for fibroids is investigating its potential application as a treatment for cancer.

The Best (Un)available Option
Charles Reinwald, president and founder of the Cancer Cure Coalition, knows first hand how frustrating the FDA’s inaction can be for discriminating healthcare consumers. After receiving a diagnosis of prostate cancer in 1999, Reinwald carefully considered all available treatment options. Despite a diagnosis of malignancy, confirmed by biopsy, Reinwald was able to suppress his elevated prostate specific antigen (PSA) levels for several years by taking a form of supplemental vitamin D, and an herbal remedy that is no longer available. When his PSA rose again, indicating active disease, he was forced to consider medical intervention. After evaluating the cons (seriously daunting) and pros (severely limited) of standard therapies, such as surgery, radiation and hormone therapy, Reinwald leaned toward cryotherapy. Because he is older than 70, surgical removal of the gland was not recommended.

Side effects of standard treatments are often serious; ranging from infection to impotence (affecting approximately 50% of patients) and incontinence (occurring in about 10% of cases). After considering side effects, estimated recovery times, and recurrence rates, Reinwald felt cryotherapy offered some advantages. Although largely abandoned as a prostate cancer treatment about two decades ago, cryotherapy has recently been resurrected, with key modifications that improve its attractiveness. But successful cryotherapy relies heavily on the experience and skill of the surgeon, who must carefully control the application of super-cooled liquid gas to freeze and thus destroy cancerous tissue. Dead cancer tissue is subsequently excreted in the urine. Despite modifications designed to spare the all-important neurovascular bundle, which is crucial to future potency and continence, cryosurgery nevertheless results in impotence in about 50% of cases.

As he learned more about the potential advantages of HIFU, Reinwald became convinced that it offered the best possible treatment option for his disease. “I felt that HIFU offered better control than a liquid gas,” says Reinwald. He based his opinion on the knowledge that the cancer-killing power of HIFU is controlled in much the same way a computer gamer zaps bad guys. A modified magnetic resonance imaging (MRI) device, integrated into the HIFU system, guides the application of ultrasound energy with point-and-click precision. The modified MRI, which has been tweaked to record small incremental changes in the temperature of surrounding tissues, contributes significantly to the accuracy and precision of the HIFU system. For the treatment of prostate cancer, patients are given an epidural, or “saddle block,” which is similar to the anesthesia given to women in labor. Although fully awake, patients feel nothing as a probe is inserted into the rectum and the prostate is imaged and then treated with HIFU. It is this unique combination of sensitive imaging and precisely controlled tissue destruction, or ablation, that renders HIFU so versatile, effective and tolerable.

After contacting a Miami-based urologist with clinic privileges in the Dominican Republic, Reinwald traveled to the Caribbean in 2004 in order to legally undergo HIFU treatment for his prostate cancer. The decision was not made lightly. Because it is unapproved in the U.S., medical insurance policies do not cover the approximately $10,000 cost of the procedure. But Reinwald returned to the states more convinced than ever that he had made the right choice.

Performed on an outpatient basis, the procedure took little more than 90 minutes. All told, including prep and recovery time, Reinwald spent just four hours in the Dominican clinic. By the following day he was able to spend the day with his wife, sightseeing, shopping and dining out. HIFU patients must wear a catheter for about a week post-procedure, as destroyed tissue and some blood drains from the urethra. But mobility is regained almost immediately. Although somewhat uncomfortable, Reinwald notes with some pride that the procedure left him fully able to carry his own luggage while traveling back home.

A Superior Technique
“It’s definitely a superior technique from a patient’s standpoint,” says Reinwald. “It’s really quite favorable as compared to other procedures…You eliminate all the nursing, recovery time, hospital stay, etc., and the side effects are less.” As an example, Reinwald notes that hormonal therapy can demasculinize a man, and may only delay progress of the disease for two to three years. As Reinwald sees it, this doesn’t represent much of an option. “They make you a eunuch. That’s conventional therapy,” he notes, wryly, adding, “It’s pharmaceutical castration.” Hormone therapy attempts to eliminate the “male hormone,” testosterone, which fuels prostate cancer growth. But the treatment leaves men in much the same condition as post-menopausal women – subject to hot flashes, moodiness and fracture-inducing osteoporosis. Reinwald feels that men tend to put up with side effects that rob them of dignity, masculinity and sexuality, because they believe they have no other choice, or they are simply too embarrassed to protest, or even to discuss their discomfort and distress.

He sees a similar situation in the current approach to breast cancer treatment. “They cut breasts off,” says Reinwald. “It’s mutilation”. He notes that this radical approach is only successful if surgeons manage to remove every single cancer cell. HIFU, in contrast, could be used to image and destroy diseased tissue, leaving healthy tissue – and breasts – intact.

Surgery and radiation for prostate cancer don’t appear to offer much better options than hormonal therapy. Both have success rates that hover around 50%. Surgery, or radical prostatectomy, is commonly restricted to patients younger than 70, due to the risk of potentially fatal complications. Because of its invasive nature, and the dangers posed by general anesthesia and possible post-op infection, surgery is not undertaken lightly. Side effects, which are alarmingly common, may seriously affect subsequent quality of life. Many patients are rendered permanently impotent, while others suffer urinary incontinence, nerve damage, etc. Some unfortunate patients suffer a combination of side effects.

“HIFU is superior technology in my opinion,” says Reinwald. “The potential for this treatment is really phenomenal. This could have a major impact on prostate cancer treatment. It could substantially reduce the need for surgery and radiation.” In fact, Reinwald is so convinced that HIFU represents a dramatic improvement over current prostate cancer treatment he calls it potentially “disruptive technology”. Like the introduction of the steam engine, which transformed whole societies, he envisions a future where HIFU may largely displace current therapies that maim and emasculate. In this hopefully not-too-distant scenario, HIFU will become an approved treatment covered by standard medical insurance; it will, in fact, become the first-line treatment of choice.

HIFU on the Horizon
Reinwald is not alone in his expectations regarding this emerging technology. Scientists around the world have conducted numerous trials of HIFU treatment for everything from breast cancer to brain tumors. Results have been immensely encouraging. In 2003, scientists in China published the results of a randomized, controlled clinical trial of HIFU for the treatment of localized (non-metastasized) breast cancer. One group of control patients underwent modified radical mastectomy, while others were treated with HIFU first, before undergoing modified radical mastectomy.

Short-term follow up, which included careful analysis of cancerous tissues, revealed that cancer cells were completed destroyed in the tissue removed from HIFU-treated patients. There were no severe side effects from HIFU, leading the research team to conclude: HIFU could be effective, safe and feasible in the [non-surgical] treatment of localized breast cancer. Although HIFU patients in this study eventually underwent mastectomy, the implications of subsequent tissue findings are that HIFU alone would have sufficed. The treated tumor cells lost the abilities of proliferation, invasion and metastasis.

Excitement about HIFU’s potential uses is building around the world. Researchers have investigated its feasibility for numerous applications, including non-surgical heart valve repair,2 wound cauterization and non-invasive treatment of breast, kidney, pancreatic, liver3, 6, 7 thyroid8 and brain cancers.9-11 The latter application is especially enticing. By designing a HIFU array mounted on a helmet-like device, scientists at Harvard Medical School have been able to demonstrate preliminary success in treating models of otherwise inoperable brain tumors. Other potential uses include non-surgical vasectomy, treatment of chronic pain and muscle spasm,12 treatment of post-partum hemmorage,13 and even bloodless surgery for emergency medical conditions encountered by astronauts in outer space.14

HIFU For You
Although HIFU treatment is not currently available to cancer patients on U.S. soil, phase III clinical trials are underway. Proponents are hopeful that FDA approval will be forthcoming shortly. HIFU is available outside of the United States. For more information about HIFU, contact the Cancer Cure Coalition.

Cancer Cure Coalition
800 Village Square Crossing
Ste. 222
Palm Beach Gardens, FL 33410
(561) 207-6184
www.cancercurecoalition.org

This Month

The Power of Two: For Anne and Charles Reinwald, overcoming cancer was just the beginning
- - -
The Power of Two Update - How Anne Became Healthy
- - -

Supporting Statements from Medical Authorities

- - -
Testimony of Dr. David Heber
- - -

Cancer Cure Coalition Launches Major Initiatives
- - -
Article Index

The Cancer Cure Coalition - 325 Beach Road, Ste. 204, Tequesta, FL 33469 - Phone/Fax 561-747-2174

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Copyright 2004 Cancer Cure Coalition. All rights reserved.

Home Donate Support Contact Breaking News FAQ Links	High hopes for HIFU By Dale Kiefer A potentially superior new technology for the non-invasive treatment of prostate carcinoma and other cancers is gaining increasing acceptance abroad. But the United States lags behind European and Asian countries in pursuing this cutting-edge procedure, despite the fact that U. S. scientists played a key role in developing the technology. HIFU, or high-intensity focused ultrasound, ingeniously expands upon familiar ultrasound imaging technology, in much the same way that a carefully positioned magnifying glass concentrates scattered sunlight into a tight beam capable of incinerating flammable objects. By increasing the energy of ultrasound waves, and focusing them into a carefully concentrated beam, HIFU-trained clinicians are capable of destroying cancerous cells while leaving healthy tissue intact. The non-, or minimally-invasive technology allows for the complete destruction of contained (non-metastasized) soft-tissue tumors without the need for potentially risky chemotherapy, radiation, or invasive surgery. In essence, HIFU enables physicians to “burn out” internal tumors from outside the body, without harming overlying skin or adjacent healthy connective tissue. Used for more than a decade to treat prostate and cervical cancers in Europe and Asia, this promising technology is unavailable to Americans in their own country. Only patients with the motivation and financial resources to travel out of the country for treatment – and pay fully out-of-pocket – may currently take advantage of this promising new technology. Although HIFU was pioneered in Indianapolis, in the heart of these United States, the U. S. Food and Drug Administration has so far failed to approve the procedure for the treatment of cancer by U.S. physicians. HIFU is, however, approved for the treatment of benign uterine fibroids in the U. S. This is especially good news, as current treatment options for this common condition include removal of the womb (i.e. hysterectomy); a radical option that forces many premenopausal women into surgically-induced menopause long before their time. It is hoped that as HIFU gains acceptance it may replace, or even eliminate the need for hysterectomies. Additionally, the company responsible for developing HIFU as a treatment for fibroids is investigating its potential application as a treatment for cancer. The Best (Un)available Option Charles Reinwald, president and founder of the Cancer Cure Coalition, knows first hand how frustrating the FDA’s inaction can be for discriminating healthcare consumers. After receiving a diagnosis of prostate cancer in 1999, Reinwald carefully considered all available treatment options. Despite a diagnosis of malignancy, confirmed by biopsy, Reinwald was able to suppress his elevated prostate specific antigen (PSA) levels for several years by taking a form of supplemental vitamin D, and an herbal remedy that is no longer available. When his PSA rose again, indicating active disease, he was forced to consider medical intervention. After evaluating the cons (seriously daunting) and pros (severely limited) of standard therapies, such as surgery, radiation and hormone therapy, Reinwald leaned toward cryotherapy. Because he is older than 70, surgical removal of the gland was not recommended. Side effects of standard treatments are often serious; ranging from infection to impotence (affecting approximately 50% of patients) and incontinence (occurring in about 10% of cases). After considering side effects, estimated recovery times, and recurrence rates, Reinwald felt cryotherapy offered some advantages. Although largely abandoned as a prostate cancer treatment about two decades ago, cryotherapy has recently been resurrected, with key modifications that improve its attractiveness. But successful cryotherapy relies heavily on the experience and skill of the surgeon, who must carefully control the application of super-cooled liquid gas to freeze and thus destroy cancerous tissue. Dead cancer tissue is subsequently excreted in the urine. Despite modifications designed to spare the all-important neurovascular bundle, which is crucial to future potency and continence, cryosurgery nevertheless results in impotence in about 50% of cases. As he learned more about the potential advantages of HIFU, Reinwald became convinced that it offered the best possible treatment option for his disease. “I felt that HIFU offered better control than a liquid gas,” says Reinwald. He based his opinion on the knowledge that the cancer-killing power of HIFU is controlled in much the same way a computer gamer zaps bad guys. A modified magnetic resonance imaging (MRI) device, integrated into the HIFU system, guides the application of ultrasound energy with point-and-click precision. The modified MRI, which has been tweaked to record small incremental changes in the temperature of surrounding tissues, contributes significantly to the accuracy and precision of the HIFU system. For the treatment of prostate cancer, patients are given an epidural, or “saddle block,” which is similar to the anesthesia given to women in labor. Although fully awake, patients feel nothing as a probe is inserted into the rectum and the prostate is imaged and then treated with HIFU. It is this unique combination of sensitive imaging and precisely controlled tissue destruction, or ablation, that renders HIFU so versatile, effective and tolerable. After contacting a Miami-based urologist with clinic privileges in the Dominican Republic, Reinwald traveled to the Caribbean in 2004 in order to legally undergo HIFU treatment for his prostate cancer. The decision was not made lightly. Because it is unapproved in the U.S., medical insurance policies do not cover the approximately $10,000 cost of the procedure. But Reinwald returned to the states more convinced than ever that he had made the right choice. Performed on an outpatient basis, the procedure took little more than 90 minutes. All told, including prep and recovery time, Reinwald spent just four hours in the Dominican clinic. By the following day he was able to spend the day with his wife, sightseeing, shopping and dining out. HIFU patients must wear a catheter for about a week post-procedure, as destroyed tissue and some blood drains from the urethra. But mobility is regained almost immediately. Although somewhat uncomfortable, Reinwald notes with some pride that the procedure left him fully able to carry his own luggage while traveling back home. A Superior Technique “It’s definitely a superior technique from a patient’s standpoint,” says Reinwald. “It’s really quite favorable as compared to other procedures…You eliminate all the nursing, recovery time, hospital stay, etc., and the side effects are less.” As an example, Reinwald notes that hormonal therapy can demasculinize a man, and may only delay progress of the disease for two to three years. As Reinwald sees it, this doesn’t represent much of an option. “They make you a eunuch. That’s conventional therapy,” he notes, wryly, adding, “It’s pharmaceutical castration.” Hormone therapy attempts to eliminate the “male hormone,” testosterone, which fuels prostate cancer growth. But the treatment leaves men in much the same condition as post-menopausal women – subject to hot flashes, moodiness and fracture-inducing osteoporosis. Reinwald feels that men tend to put up with side effects that rob them of dignity, masculinity and sexuality, because they believe they have no other choice, or they are simply too embarrassed to protest, or even to discuss their discomfort and distress. He sees a similar situation in the current approach to breast cancer treatment. “They cut breasts off,” says Reinwald. “It’s mutilation”. He notes that this radical approach is only successful if surgeons manage to remove every single cancer cell. HIFU, in contrast, could be used to image and destroy diseased tissue, leaving healthy tissue – and breasts – intact. Surgery and radiation for prostate cancer don’t appear to offer much better options than hormonal therapy. Both have success rates that hover around 50%. Surgery, or radical prostatectomy, is commonly restricted to patients younger than 70, due to the risk of potentially fatal complications. Because of its invasive nature, and the dangers posed by general anesthesia and possible post-op infection, surgery is not undertaken lightly. Side effects, which are alarmingly common, may seriously affect subsequent quality of life. Many patients are rendered permanently impotent, while others suffer urinary incontinence, nerve damage, etc. Some unfortunate patients suffer a combination of side effects. “HIFU is superior technology in my opinion,” says Reinwald. “The potential for this treatment is really phenomenal. This could have a major impact on prostate cancer treatment. It could substantially reduce the need for surgery and radiation.” In fact, Reinwald is so convinced that HIFU represents a dramatic improvement over current prostate cancer treatment he calls it potentially “disruptive technology”. Like the introduction of the steam engine, which transformed whole societies, he envisions a future where HIFU may largely displace current therapies that maim and emasculate. In this hopefully not-too-distant scenario, HIFU will become an approved treatment covered by standard medical insurance; it will, in fact, become the first-line treatment of choice. HIFU on the Horizon Reinwald is not alone in his expectations regarding this emerging technology. Scientists around the world have conducted numerous trials of HIFU treatment for everything from breast cancer to brain tumors. Results have been immensely encouraging. In 2003, scientists in China published the results of a randomized, controlled clinical trial of HIFU for the treatment of localized (non-metastasized) breast cancer. One group of control patients underwent modified radical mastectomy, while others were treated with HIFU first, before undergoing modified radical mastectomy. Short-term follow up, which included careful analysis of cancerous tissues, revealed that cancer cells were completed destroyed in the tissue removed from HIFU-treated patients. There were no severe side effects from HIFU, leading the research team to conclude: HIFU could be effective, safe and feasible in the [non-surgical] treatment of localized breast cancer. Although HIFU patients in this study eventually underwent mastectomy, the implications of subsequent tissue findings are that HIFU alone would have sufficed. The treated tumor cells lost the abilities of proliferation, invasion and metastasis. Excitement about HIFU’s potential uses is building around the world. Researchers have investigated its feasibility for numerous applications, including non-surgical heart valve repair,2 wound cauterization and non-invasive treatment of breast, kidney, pancreatic, liver3, 6, 7 thyroid8 and brain cancers.9-11 The latter application is especially enticing. By designing a HIFU array mounted on a helmet-like device, scientists at Harvard Medical School have been able to demonstrate preliminary success in treating models of otherwise inoperable brain tumors. Other potential uses include non-surgical vasectomy, treatment of chronic pain and muscle spasm,12 treatment of post-partum hemmorage,13 and even bloodless surgery for emergency medical conditions encountered by astronauts in outer space.14 HIFU For You Although HIFU treatment is not currently available to cancer patients on U.S. soil, phase III clinical trials are underway. Proponents are hopeful that FDA approval will be forthcoming shortly. HIFU is available outside of the United States. For more information about HIFU, contact the Cancer Cure Coalition. Cancer Cure Coalition 800 Village Square Crossing Ste. 222 Palm Beach Gardens, FL 33410 (561) 207-6184 www.cancercurecoalition.org		This Month The Power of Two: For Anne and Charles Reinwald, overcoming cancer was just the beginning - - - The Power of Two Update - How Anne Became Healthy - - - Supporting Statements from Medical Authorities - - - Testimony of Dr. David Heber - - - Cancer Cure Coalition Launches Major Initiatives - - - Article Index