High Intensity Focused Ultrasound (HIFU) for Prostate Treatment

What HIFU Is and How It Works

High intensity focused ultrasound, HIFU, is a procedure that uses a robotically guided ultrasound probe, inserted transrectally, to destroy small, targeted areas of prostate tissue with heat rather than with a blade or radiation. The principle is the same as concentrating sunlight through a magnifying glass. Sound waves that are harmless on their own are focused onto a single point inside the prostate, and at that point the temperature rises rapidly, to around ninety degrees Celsius, denaturing proteins in the tissue and causing coagulative necrosis. Tissue outside the focal point is left largely undisturbed.

The urologist first scans the whole prostate with the same transrectal probe, building a three dimensional image on screen. The treatment area is then planned on that image, and the system calculates the number and pattern of lesions needed before delivering the ultrasound energy. A temporary urinary catheter is fitted afterwards to manage swelling, and is usually removed within a few days at a follow up visit.

Two broad approaches exist. Whole gland ablation treats the entire prostate, in the way early trials in the 1990s and 2000s did. Focal therapy, the newer and now more common approach, treats only the area containing the significant tumour, described by proponents as a lumpectomy equivalent for the prostate, sparing the nerves and muscles responsible for continence and erectile function wherever possible.

History

The scientific foundation goes back much further than most patients realise. Wood and Loomis described the thermal effects of high frequency sound waves in 1927. In 1942, Lynn and colleagues built a focused ultrasound generator capable of creating precise thermal injury in liver tissue and, remarkably, in the brains of animals through an intact skull. In the 1950s the Fry brothers developed a transcranial version used after craniotomy to treat movement disorders such as Parkinson's, which sustained research interest in focused ultrasound for decades afterwards.

The prostate became the organ of choice for HIFU researchers in the early 1990s, largely because it could already be imaged well with ultrasound. Two devices emerged at roughly the same time. Bihrle and colleagues at Indiana University worked with Focus Surgery's Sonablate device in the United States, achieving the first human prostate tissue ablation in 1994. Marberger and colleagues in Europe, working with the EDAP device, followed in 1995. Doctor Uchida and his team in Japan then used the Sonablate device to treat men with localised prostate cancer, publishing a preliminary report in 2002.

In June 2001, doctors Gardner and Koch at Indiana University performed the first whole gland HIFU ablation in the United States. Feasibility trials for localised and recurrent prostate cancer followed in 2003 and 2005. A multicentre phase three registration trial was then designed, but its enrolment stalled for close to a decade, partly because of the cost of running the trial and partly, according to the treating physicians who documented this history, because American men were travelling offshore to Mexico and the Dominican Republic for the same procedure, reducing the incentive to enrol in the US trial itself.

Both principal devices, SonaCare Medical's Sonablate and EDAP's Ablatherm, were finally cleared by the Food and Drug Administration in October 2015. It is worth being precise about what that clearance actually covers. The FDA cleared these devices for the ablation of prostate tissue. It did not grant approval specifically for the treatment of prostate cancer as a diagnosis. That distinction has had real consequences: because HIFU is not FDA approved as a cancer treatment, insurers have historically treated it as an unproven or experimental therapy for that purpose, and a proper billing code, CPT 55880, was not assigned until January 2021, more than five years after clearance.

Before the 2015 clearance, in 2014 and 2015 alone, thousands of American men are reported to have travelled abroad, principally to Mexico, the Bahamas, and Bermuda, to obtain HIFU treatment that was not yet available to them at home.

The Devices in Use Today

Four manufacturers currently hold US clearance for prostate tissue ablation using focused ultrasound: Sonablate Corp, EDAP TMS, Profound Medical, and Insightec. According to physicians interviewed by Urology Times, well over ninety per cent of US cases historically have used the Sonablate 500. EDAP TMS, a French company, markets the older Ablatherm and the newer, robotically controlled Focal One, which is the platform most commonly referenced by Dallas providers. Insightec's ExAblate is an MRI guided transrectal system. Profound Medical's TULSA-PRO works on a related but distinct principle: it is delivered transurethrally rather than transrectally, under continuous MRI guidance, and is often discussed alongside HIFU though it is a different device category.

Clinicians who have used more than one system note that the size and precision of the thermal lesion differs between devices, with the Ablatherm producing a larger lesion than the Sonablate, making the newer, more image guided systems better suited to sparing the neurovascular bundles that control erectile function.

The Scientific Evidence

The most rigorous recent evidence comes from a 2024 systematic review and meta-analysis published in Prostate Cancer and Prostatic Diseases, which pooled outcomes from forty nine separate treatment cohorts published between 2008 and 2024, twenty of which used HIFU specifically, with cryotherapy and irreversible electroporation making up the remainder. Median follow up across the pooled cohorts was around twenty eight months. The pooled figures were an overall survival of 98.0 per cent, a cancer specific survival of 99.3 per cent, and a metastasis free survival of 98.5 per cent, with no meaningful difference found between HIFU, cryotherapy, or electroporation on any of these measures.

The same review found that when a follow up biopsy was mandated within twenty four months, an average of 22.2 per cent of patients still had clinically significant cancer detected somewhere in the gland, split roughly between recurrence in the treated area and new disease found outside it. Around five per cent of patients required a second focal procedure, and 10.5 per cent went on to have salvage radical treatment, meaning conventional surgery or radiation, within the follow up period. The review's own authors were candid about its limits, concluding that reporting across studies remains inconsistent and that longer term, standardised follow up data are still needed before firm conclusions can be drawn.

A separate French trial published in 2024, run across forty six centres and enrolling more than 3,300 patients, is the largest study to date and reported that HIFU was non inferior to standard surgery on oncological outcomes at thirty months, with favourable functional results, meaning continence and erectile function, at twelve months. Other named studies feeding this evidence base include the FOXPRO trial, published in European Urology Focus in 2023, and a Swiss prospective trial reported in BJU International in 2024 with three years of follow up. A German group led by Ganzer has also published fourteen year outcomes for HIFU, among the longest follow up periods available for any focal therapy.

Earlier evidence, summarised in a widely cited 2016 review in European Urology, found that when the whole gland is treated, rates of erectile dysfunction after HIFU are broadly similar to those seen after surgery, though incontinence rates are generally lower. When only the diseased portion of the gland is treated, side effects are reduced further, though not eliminated.

Concerns From the Conventional Urology Community

HIFU's path to acceptance has been genuinely contested, and the disagreement has not been confined to marketing versus scepticism, it has run through the FDA's own advisory process. Advisory committees to the FDA recommended against clearing HIFU as a prostate cancer treatment on two separate occasions before the 2015 clearance, citing insufficient long term evidence. The clearance that was eventually granted, for tissue ablation rather than for cancer treatment as such, reflects that unresolved caution rather than a resolution of it.

The debate continued well after clearance. In a published exchange hosted by Grand Rounds in Urology, doctor Erik Castle argued that HIFU, as the technology stood, produced too many negative quality of life outcomes to be considered ready for standard use, while doctor David Beyer argued the opposite, that enough randomised and clinical evidence already existed to treat it as standard of care. A 2011 paper in the Canadian Journal of Urology stated plainly that HIFU should remain a treatment used only in the context of a clinical trial, and should not be considered a standard option for localised prostate cancer.

A recurring, more structural concern has been financial rather than purely clinical. Doctor Jim Hu of Weill Cornell, writing with colleagues in the Journal of the American Medical Association, pointed out that because HIFU has largely been paid for in cash by patients rather than reimbursed by insurers, there has been little external pressure on providers to generate the long term efficacy data that would normally be required to secure insurance coverage. His view, reported by Kaiser Health News in 2016, was direct: men were being charged twenty five thousand dollars for the procedure, yet no one felt pressure to demonstrate its efficacy, because the absence of insurance reimbursement removed the usual mechanism that would force that evidence to be collected. Hu and colleagues called for a national outcomes registry, an idea that has since progressed only partially, with a UK based registry now open to some US device users.

A separate clinical concern relates to the multifocal nature of prostate cancer itself. Doctor Justin Beckelman, a radiation oncologist at the University of Pennsylvania, has noted that while a dominant tumour may be identified and targeted, smaller cancer cells often exist elsewhere in the gland that focal treatment does not address, which is consistent with the meaningful rate of out of field recurrence found in the 2024 meta-analysis above. Finally, HIFU is repeatedly described, including by proponents, as having a steep learning curve, with outcomes strongly dependent on operator experience. Poorly trained physicians using the technology have been reported to produce complication rates similar to more invasive conventional treatments, which is precisely the advantage HIFU is meant to avoid.

Benefits Cited by Doctors Who Use It

Physicians who have adopted HIFU consistently point to a similar set of advantages. It is an outpatient procedure, typically completed in forty five minutes to ninety minutes under general anaesthesia, with same day discharge and a return to normal activity within two to three days. It involves no incision, no blade, and no radiation, and it does not foreclose future treatment options: unlike surgery or radiation, HIFU can be repeated, and generally does not prevent a patient from later having conventional surgery or radiation if that becomes necessary.

The central clinical argument made by treating urologists is quality of life preservation. Robotic, image guided systems such as Focal One are described as allowing the urologist to customise the ablation to spare the neurovascular bundles and the urinary sphincter, reducing rates of erectile dysfunction and incontinence relative to whole gland treatments, while producing oncological control that several of the studies above describe as comparable to radical prostatectomy over the medium term. Doctors also position it as a middle option for men who are uncomfortable simply monitoring a lower risk cancer under active surveillance, but who also want to avoid the side effect profile of immediate surgery or radiation.

Cost and Insurance Landscape

Reported prices for HIFU in the United States have varied over time and by source. In 2016, investigative reporting by Kaiser Health News and STAT put the typical cost at between fifteen thousand and twenty five thousand dollars. A 2023 Healthline estimate put the range lower, at ten thousand to fifteen thousand dollars, while the medical cost marketplace MDsave lists procedure pricing between roughly thirteen thousand six hundred and sixteen thousand dollars. A specialist HIFU centre in Florida, one of the highest volume providers in the country, currently quotes an average all-in out of pocket cost, covering physician fees, anaesthesia, and facility charges, of around twenty six thousand dollars for HIFU and thirty two thousand five hundred dollars for TULSA-PRO.

A CPT billing code, 55880, was assigned to transrectal HIFU ablation of the prostate effective January 2021, with a related code, 55882, covering TULSA-PRO. These codes allow Medicare to reimburse the hospital or facility component of the procedure when it is performed in a hospital based outpatient setting, and in early 2025 the Focused Ultrasound Foundation reported a proposal to increase that facility reimbursement level. Critically, the physician's own professional fee is frequently not covered by Medicare, particularly where the treating physician has formally opted out of the Medicare program, as is the case at the Florida centre referenced above. Commercial insurers, including Blue Cross, Aetna, United, and Cigna, still do not routinely reimburse HIFU automatically, though patients have in many cases obtained partial or full reimbursement on appeal after treatment. Financing programmes for the remaining out of pocket balance are commonly offered by treatment centres.

HIFU in Dallas, Texas

Several providers across the Dallas-Fort Worth Metroplex now offer HIFU, most using the EDAP Focal One robotic platform. Publicly available detail on individual physician experience and patient volume is uneven. One provider publishes a detailed, named physician history; others describe the service only in general terms, without naming the specific urologist performing it or stating how many patients they have personally treated. That distinction is reflected below.

Doctor James Cochran, Texas Prostate, Farmers Branch

Doctor James Cochran, MD, DABU, FRSC, is the most extensively documented HIFU practitioner in the region. He is a board certified urologist with forty five years of clinical and research experience in the Dallas-Fort Worth Metroplex. He co-founded the Urology Clinics of North Texas, now the largest independent urology practice in the Metroplex, where he served as Chief Medical Officer overseeing FDA clinical trials for the group.

According to his own published biography, doctor Cochran became a trained user of the Sonablate transrectal HIFU system when it first became available, was designated a Principal Investigator on one of the trials that led to the device's FDA clearance, and is a certified proctor for the technology, meaning he is qualified to train other urologists in its use, which he has done for numerous physicians. His practice states he has been offering HIFU to patients across Texas and beyond for over twenty five years, and describes his patient volume as hundreds of men treated. These are figures published by his own practice rather than independently audited totals, and should be read with that in mind.

In 2020, doctor Cochran trained on the TULSA-PRO system and, with doctor Rajiv Chopra, co-founded Texas Prostate to offer both HIFU and TULSA-PRO in a dedicated setting. He is also a prostate cancer survivor himself, having undergone a radical prostatectomy roughly twenty six years ago, which his practice presents as giving him first hand understanding of a prostate cancer diagnosis from the patient's side. Earlier in his career he was the first urologist in the Metroplex to introduce several procedures that are now standard of care, including percutaneous nephrostolithotomy, shockwave lithotripsy, microsurgical vasectomy reversal, nerve sparing radical prostatectomy, and laparoscopic nephrectomy, before adding focused ultrasound to that list.

Urology Clinics of North Texas

Urology Clinics of North Texas is an independent private practice formed in 1999 through the merger of several established urology groups, and now operates across Dallas, Allen, Carrollton, Denton, Flower Mound, Fort Worth, Frisco, Garland, Grapevine, McKinney, Mesquite, Plano, Rockwall, and Sunnyvale, with more than five hundred staff including urologists, radiation oncologists, medical oncologists, and pathologists. The group offers Robotic Focal HIFU using the Focal One platform, describing the procedure as a forty five minute to one hour outpatient treatment. The group's public materials do not name the individual urologist or urologists currently performing the procedure, nor do they publish a specific patient count or years of HIFU experience for the practice as a whole, separate from doctor Cochran's own history noted above from his time with the group.

Methodist Health System

Methodist Health System offers Robotic Focal HIFU using the Focal One platform at its Southwest and Charlton medical centres in the Dallas area, describing the procedure as performed by "a urologist on the Methodist medical staff." The publicly available page does not name the treating physician, does not state how long the programme has been running, and does not publish a patient volume figure, so no comparable detail can be given here without direct enquiry to the hospital system.

Texas Health Dallas

Texas Health Dallas has been described in search indexing as the first hospital in the Southwest region of the United States to offer HIFU. At the time of this review, the specific page describing that programme could not be retrieved, so this claim is noted but not independently verified here, and would need direct confirmation from Texas Health Resources before being relied upon.

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