HIFU (high-intensity focused ultrasound) is a focal therapy for prostate cancer that uses focused ultrasound waves to destroy the tumor without incisions and without removing the entire prostate.In 2026, the Federal Medical Council removed the experimental status of the technique in Brazil, recognizing HIFU as an official therapeutic option.
What is HIFU and how does it work?
HIFU is a thermal ablation technique. High-energy ultrasound waves are directed at the tumor site, raising the temperature between 65°C and 100°C. This concentrated heat causes coagulative necrosis, meaning localized destruction of tumor cells.
The procedure is performed transrectally or guided by real-time MRI. Only the tumor lesion or one side of the gland (hemigland) is treated. The rest of the prostate, the nerve bundles responsible for erections, the urinary sphincter, and the rectum are preserved.
What changes with CFM approval?
Until recently, HIFU was offered in Brazil under experimental status. The Federal Medical Council has removed this condition and recognized the technique as an official treatment for localized prostate cancer in selected patients.
In practice, three factors change:
- HIFU can be offered outside of research protocols.
- Doctors and hospitals can indicate it within routine clinical practice.
- The path for inclusion in health insurance coverage is underway.
Who is HIFU indicated for?
Patient selection is the most critical step of treatment. HIFU is indicated for localized prostate cancer of low to intermediate risk, with a visible and well-defined tumor on MRI.
The criteria are:
- Localized cancer without extracapsular extension.
- Cancer confined to only one side (lobe) of the prostate.
- Up to two lesions mapped on MRI.
- Clinical stage T1c-T2.
- Life expectancy of at least 10 years.
For aggressive tumors, such asGleason 8 prostate cancer, bilateral disease or already metastatic, HIFU is not the recommended option.
How is HIFU performed?
The procedure is done in an operating room under anesthesia. There is no skin incision and no tissue is removed.
The critical step happens before the procedure. Multiparametric MRI identifies the lesion's location. Patients undergoing HIFU must also have a prostate biopsy with image fusion, and there must be correlation between the MRI and biopsy results, meaning the suspicious area on the MRI must match the positive fragments in the prostate biopsy.
During treatment, the transrectal probe applies successive pulses of focused ultrasound. Each pulse heats a small volume of tissue, and together they cover the area to be treated (usually half of the gland).
What are the oncological outcomes?
About 90% of patients remain free of significant residual disease in the treated area after HIFU application. The 5-year metastasis-free survival rate is nearly universal.
The 5-year biochemical recurrence-free survival rate is above eight out of ten patients in low or intermediate-risk cases. In high-risk cases, this result drops significantly, reinforcing the importance of not recommending HIFU for aggressive tumors.
What are the benefits of HIFU?
The main advantage of HIFU compared to radical treatments is preservation of structures adjacent to the prostate, directly impacting the patient's quality of life.
- Urinary continence preservation: 94 to 100% of patients do not require absorbent pads.
- Targeted treatment: preserving healthy prostate tissue and adjacent structures.
- Minimally invasive procedure: performed with a transrectal probe, no skin incision.
- Option for focal retreatment preserved: in case of residual disease.
What are the risks of HIFU?
The main risk of HIFU is the possibility of leaving behind an undetected cancer focus in prostate areas not treated. Additionally, local recurrence (in situ), meaning tumor regrowth in the treated region, can occur.
From an oncological perspective, robotic prostatectomy offers more established and comprehensive cancer control. On the other hand, HIFU's main advantage is being a less invasive treatment, associated with lower risks of urinary incontinence and erectile dysfunction.
Some adverse events are:
- Bladder neck or urethral stricture, treatable later.
- Temporary urinary symptoms in the first month: burning, urgency, and increased urinary frequency.
- Acute epididymitis, in about 11% of patients, treatable with targeted medication.
- Rectal fistula, extremely rare.
Is HIFU covered by health insurance?
With recent approval by the CFM, the path to including HIFU coverage in insurance plans is underway. Currently, many procedures are done privately, and it is up to the patient to confirm individual coverage with their provider.
Prostate cancer treatment in Manaus
I see prostate cancer patients in our office in Manaus and advise on all treatment options, including focal therapy with HIFU for selected cases. When HIFU or robotic surgery is indicated, I perform these procedures in São Paulo, with robotic in Manaus expected soon. If you have received the diagnosis, contact our dedicated assistant to schedule an evaluation.
