Imaging and generation of the tumor-destroying ultrasound wave are performed using a probe placed in the rectum. The wave-emitting element is shaped to precisely target the area where cell necrosis occurs. The imaging element allows for the localization of the treatment area and real-time monitoring of the procedure. A computer system ensures treatment planning, controls the transducer’s movements, and ensures automatic monitoring of the procedure’s accuracy. Planning the procedure can be compared to arranging three-dimensional blocks into a solid, which then becomes a volume exposed to a high-energy wave.
Prostate cancer treatment using HIFU technology is minimally invasive. The patient undergoes HIFU under epidural or general anesthesia. The procedure lasts 2-3 hours, depending on the size of the tumor. Patients can be discharged home the next day after the procedure. A catheter is recommended for 7-10 days or longer. Outpatient procedures are also possible. HIFU treatment has been performed on over 30,000 patients worldwide.
Prostate Cancer
Prostate cancer is the second most common cancer in men in Poland, after lung cancer. Its incidence increases with age, and according to epidemiological studies, it affects 80% to 90% of men over the age of 75. Fear of cancer detection often prevents men from seeking diagnostic tests, leading to delays in starting treatment. As a result, as many as 10 men die from prostate cancer every day. In the early stages of the disease, the cancer is asymptomatic. That’s why early detection of prostate cancer, when it affects only the prostate gland, is so important. This significantly increases the chance of a complete cure. Three components play a key role in prostate cancer diagnosis:
- a rectal examination, which in most cases allows for the detection of nodules located within the prostate, which may suggest the presence of cancer to the doctor.
- a laboratory test – measuring the PSA level (prostate-specific antigen). An elevated serum level exceeding 4 ng/L may suggest the presence of cancer and require further evaluation.
- a diagnostic test – transrectal ultrasound (TRUS) with a prostate biopsy and histopathological evaluation of the collected material. This allows for the detection of cancer and its classification according to the Gleason score.
The higher the Gleason score (from 1 to 10), the poorer the prognosis. Once cancer is detected, imaging tests such as computed tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy, or PET/CT are performed to determine the stage of disease progression and the appropriate treatment method. Depending on the stage of disease, various treatment options are available, including surgery, external beam radiotherapy, brachytherapy, hormone therapy, chemotherapy, and HIFU. Several treatment methods are often combined to achieve the best possible results. Early detection of prostate cancer offers the opportunity to benefit from effective yet less invasive prostate cancer treatment methods, such as HIFU. Surgical treatment involves radical prostatectomy, which involves the complete removal of the prostate gland. This can be performed conventionally via a suprapubic approach or laparoscopically. Prostatectomy performed in the early stages of disease allows for a complete cure in over 90% of patients. During surgery, the entire prostate gland, including the seminal vesicles (and in some cases, the surrounding lymph nodes), is removed, and the removed tissue is subjected to histopathological examination, which allows for an assessment of the disease’s advancement and the radicality of the procedure. The surgery requires a hospital stay of 3 to 7 days, depending on the disease’s severity, extent, and the procedure (classical or laparoscopic). Radiotherapy is a treatment method using ionizing radiation or a radioactive isotope that kills cancer cells. Two methods are used: external beam radiotherapy, also known as “exposure to light,” or “lamps,” lasting up to 6 weeks, and brachytherapy, which involves implanting radioactive isotope particles into the prostate gland.
Radical radiotherapy is comparable in effectiveness to surgery. It is the treatment of choice for patients who do not want or cannot undergo surgery. It is also a therapeutic option when other treatments fail. Hormone therapy is based on the hormone dependence of prostate cancer cells, which require testosterone, the male sex hormone, to function properly. Administering drugs that lower testosterone levels in the blood inhibits cancer growth. Chemotherapy, or the administration of cystostatic drugs, is used in men with advanced, disseminated cancer. HIFU (High Intensity Ultrasound) – this method involves the use of a concentrated beam of high-intensity ultrasound waves. The ultrasound exposes cancerous tissue to temperatures above 80 degrees Celsius, causing cell necrosis in the prostate gland. All patients after prostate cancer treatment remain under the supervision of a urologist or oncologist and, if necessary, undergo adjuvant treatment. Indications for HIFU: The indications for HIFU treatment are listed below. They were developed based on experience gained performing these procedures at leading urology centers worldwide.
1. Cancer stage: confined to the gland, T1-T2 N0 M0.
2. Gleason score ≤ 7.
3. PSA < 15 ng/ml (initial PSA measurement).
4. Prostate volume ≤ 40 ml.
5. Rectal mucosa without lesions, with normal anatomy (rectal wall thickness < 8 mm).
6. No symptoms suggestive of urinary tract disease.
7. Patients not eligible for radical prostatectomy.
8. Patients refusing radical surgery.
9. Patients who have failed brachytherapy.
10. Patients with local recurrence following radiotherapy.
11. Patients with local recurrence after radical prostatectomy
HIFU treatment results
Five- and seven-year results demonstrate high cure rates, ranging from 63 to 87%, depending on the center performing HIFU treatments. Clinical studies also report a very high percentage of patients without tumor recurrence and long-term survival without distant metastases, ranging from 87% to as much as 99% in the study groups. The results of HIFU are comparable to those achieved with radiotherapy. The advantage of HIFU technology is the low risk of side effects for the patient, as well as the possibility of repeating the procedure in the event of disease recurrence. Of note, HIFU can be performed on patients with recurrent cancer after prior radiotherapy, brachytherapy, or prostatectomy. At a reference center in Lyon, France, HIFU treatments are routinely performed after radiotherapy failure. As with other therapeutic procedures, complications may occur following HIFU treatment. The most common include:
- Prostatic edema, prostatic necrosis and associated urinary incontinence and lower urinary tract symptoms (LUTS)
- Need for urinary diversion via a suprapubic fistula or catheter for more than 40 days
- Chronic urinary tract infection
- Degree I urinary incontinence 4-6%
- Degree II urinary incontinence 2%
- Degree III urinary incontinence less than 1%
- Erectile dysfunction associated with damage to the neurovascular bundles
- Uretral-anal fistula
- Urethral stenosis