MRI-Guided Focal TULSA-PRO Treatment for Prostate Cancer

The world’s first focal TULSA-PRO treatment of the prostate was carried out at the ALTA Klinik.

The aim of TULSA-PRO treatment is to destroy prostate cancer while leaving the prostate as functionally intact as possible so as to enable patients to retain normal erectile function and avoid urinary incontinence. Our TULSA-PRO treatment outcomes demonstrate our ability to achieve this aim for our patients.

The TULSA-PRO treatment is based on the carefully targeted use of ultrasound energy to destroy, or effectively ablate, diseased tissue in the prostate via thermal coagulation. The ultrasound applicator delivers beams of ultrasound to the tissue in the ablation target area, heating the tissue to the desired range of up to 86 °C. Given that the applicator remains cool throughout the procedure, you doctor can limit the scope of the thermal ablation to precisely demarcated target areas and reduce the risk of damage to healthy prostate tissue and neighboring structures such as the neurovascular bundles, the urinary sphincters and the rectum.

TULSA stands for Transurethral ULtraSound Ablation.

  • The term transurethral means “through the urethra.”
  • Ablation means the “removal of bodily tissue” (in this case via thermal energy).
  • Focal treatment means that the treatment limited to a precisely demarcated target area.

In the case of larger or multiple prostate tumors, the treatment may involve the removal of one-quarter of the prostate (quadrant ablation) or one-half of the prostate (hemiablation). If a patient also suffers from benign prostatic hyperplasia (BPH), the scope of the treatment can be extended to include the excessive tissue growth so as to eliminate the symptoms associated with BPH.

Quadrant Ablation of the Prostate

The Advantages of TULSA-PRO

The focal application of MRT-guided TULSA-PRO offers men the following important advantages:

  • Retention of the prostate as an organ
  • Retention of erectile function
  • Avoidance of urinary incontinence
  • Retention of ejaculatory function
  • Protection of neighboring structures
Patient S. J., 69 years old"It’s a minimally invasive and very successful form of treatment."

In the spring of 2017, I was caught by surprise when my doctor notified me that my PSA score was well above normal. An MRI scan then confirmed a case of suspected prostate cancer. My urologist recommended a conventional transrectal needle biopsy to clarify the matter. However, when I read my copy of the consent form for the biopsy at home later that day, I felt uneasy. I read up on the various biopsy procedures available, and then contacted a friend of mine who’s a medical doctor. He told me that he’d undergone conventional needle biopsy on multiple occasions, only to wind up with repeated false negatives, while his PSA score continued to rise. In the end, he went to the ALTA Klink where he underwent an MRI-guided biopsy that confirmed the presence of prostate cancer. I read about the procedure and made an appointment for an MRI-guided biopsy. The result wasn’t what I was hoping for, but I was relieved to finally know for sure what I was up against: prostate cancer with a Gleason score of 7 (3+4).

Headed up by Dr. Lumiani, the ALTA Klinik offers an enhanced form of HIFU treatment for prostate cancer known as TULSA PRO. After meeting with Dr. Lumiani and learning more about what has become a very successful form of treatment, I decided to go ahead and have the prostate tumor removed. I underwent the procedure on July 26, 2017 at 11:00 a.m. It wound up lasting around 50 minutes because the tumor was rather large. At 4:00 p.m., I was then able to walk, with some minimal assistance on the part of the clinic staff, the 400 meters to the inpatient unit, and was discharged in stable condition on the very next day. As was born out in my case, it’s a minimally invasive and very successful form of treatment.

Six months have now passed. All of my follow-up examinations have gone smoothly and the results were what I was hoping for. I can definitely recommend this form of treatment to anyone else whose prostate cancer has been detected on time.

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Aspects of TULSA-PRO Treatment

Focal TULSA-PRO treatment is based on the targeted and controlled application of ultrasound energy to destroy, or effectively ablate, cancerous tissue via thermal coagulation while at the same time conserving the prostate as an organ. This requires a precise 3D mapping of the prostate tumor using MRI in advance of the procedure, as well as the intraoperative (real-time) control of the ablation procedure via MRI. When mapping the disposition of a tumor, special attention is given to the location of the structures responsible for normal erectile and urinary function, so as to ensure that these remain intact.

At the start of the minimally invasive procedure, a thin device known as an applicator is inserted through the urethra to the prostate gland, therefore enabling your doctor to remove diseased prostate tissue from within the prostate while preventing damage to other structures in the body such as the rectum and the urinary bladder.

The applicator comes with an integrated cooling system. The cooling system protects the urethra and neighboring structures such as the ejaculatory ducts from excessive heat, particularly when ultrasound energy is being applied to successively ablate the diseased tissue within the prostate.

A cooling device is also inserted into the rectum at the start of the procedure to provide an added measure of safety – in particular, to protect the neurovascular bundles, which run close to the rectum and adjacent to the prostate, and are responsible for normal erectile function.

In addition to precise planning and the exact demarcation of the ablation target area, it is also necessary to precisely control the distribution of thermal energy during the TULSA-PRO procedure. This is accomplished via MR-thermometry, which essentially enables real-time thermal monitoring of the ablation target area and its surroundings, as well as feedback-controlled, ultrasound ablation of the tissue in the ablation target area.

The targeted and controlled application of thermal energy ensures that the diseased tissue, plus an additional safety margin, can be successively and uniformly ablated while tissue outside the target area remains intact.

The diseased tissue that has been destroyed via thermal coagulation is then gradually removed from the body in the course of time. A decline in the patient’s PSA level is also observed.

Mechanism of Action and Aim of TULSA-PRO

The aim of TULSA-PRO is to systematically destroy diseased tissue in the prostate via the application of ultrasound energy. Instead of radiation, the mechanism of action is based on the precisely targeted and controlled delivery of ultrasound beams to heat and effectively ablate the tissue in a circumscribed ablation target area. The desired effect is the destruction of the targeted tissue via coagulation and not vaporization.

With the patient under general anesthesia, the ultrasound energy is applied to the diseased tissue with an applicator that is inserted through the urethra to the prostate. The applicator is a very thin rod-shaped device outfitted with a linear array of 10 independently controllable ultrasound transducers. Turning the applicator to various degrees enables your doctor to reach any area within the prostate.

Applicator with 4 activated transducers

Final planning for the procedure is carried using real-time MRI scans. This means that MRI scans of the prostate and its neighboring structures are generated while the applicator is in position. This allows your doctor to precisely demarcate the ablation target area.

Special attention is also given to the location of the structures straddling the prostate that are essential for normal urinary and erectile function so that these structures can be left intact.

MR-thermometry is used to continuously monitor the intensity and distribution of the ultrasound energy applied to the diseased tissue. The high-resolution scans MRI generated during the procedure enable your doctor to continuously track the temperature at all points in the prostate and its immediate vicinity. This permits intraoperative adjustments whenever necessary and an enhanced degree of patient safety, both with respect to the treatment aim and the prevention of unwanted side effects.

Real-time monitoring of temperature development in an ablation target area in the prostate

The TULSA-PRO Procedure

With the patient under general anesthesia, the applicator is inserted through the urethra to the prostate. The patient is moved into the MRI scanner. A check is made of the applicator’s exact position. Final mapping of the ablation target area is then completed at the MRI console in preparation for the ablation procedure.

The applicator is outfitted with an array of transducers that are each capable of delivering ultrasound energy to raise the temperature of and systematically coagulate the diseased tissue in the precisely demarcated ablation target area in the prostate.

The applicator is also outfitted with an integrated cooling system that cools and protects the wall of the urethra and nearby structures while intense heat is applied to the ablation target area. Additional protection is secured by inserting a second cooling system into the rectum.

MR-thermometry is used to continuously monitor the intensity and distribution of the emitted ultrasound energy in the ablation target area and its surroundings. This enables your doctor to confirm the application of the temperature required to destroy the cancerous tissue.

The figure below shows a TULSA-PRO procedure in which transducers 2, 3, 4, and 5 emit ultrasound energy to completely destroy a prostate tumor. Transducers 1, 6, 7, 8, 9 and 10 remain inactive and generate no heat.

TULSA-PRO as a Curative Treatment

TULSA-PRO treatment is performed with curative intent in patients with organ-confined, low and intermediate-risk tumors (Gleason score of 6 or 7).

In addition to a Gleason score within the specified malignancy range, the prerequisites for TULSA-PRO treatment include the availability of precise information about the position, size and extent of a tumor.

Additional prerequisites for focal prostate-cancer treatment include tumor localization, i.e. tumors that are entirely confined within the prostate and have not yet invaded the prostate capsule or spread beyond the prostate (extracapsular extension). Similarly, curative intent presupposes that the cancer has not spread to neighboring structures and that no metastases have formed in lymph nodes, bones or other organs.

Finally, when it comes to retaining normal prostate function, consideration also needs to be given to the spatial relationship between the tumor and the structures responsible for normal prostate function.

TULSA-PRO as Palliative Treatment

TULSA-PRO treatment also represents an effective a form of palliative care:

  • For cases of local recurrence
  • For cases of high-risk prostate cancer (Gleason score of 8 to 10)
  • For cases of non-localized tumors in need of local intervention

Local recurrence

Prostate cancer sometimes reappears after primary intervention involving radiation therapy, IRE, cryotherapy, HIFU and subtotal prostatectomy. In such cases, renewed local intervention often remains a viable option. Such intervention is commonly referred to as salvage therapy. However, both salvage surgery and salvage radiation therapy are often associated with complications.

TULSA-PRO is also an effective form of salvage therapy, for instance, to treat cases of local recurrence after subtotal prostatectomy, radiation therapy, and various forms of minimally-invasive treatment.

TULSA-PRO is an MRI-guided treatment method. In addition to a high degree of precision, this enables the continuous monitoring and control of temperature development in and around the ablation target area (thermometry) and leads to a high degree of safety. TULSA-PRO enables your doctor to precisely target and comprehensively destroy recurrent cancer while at the same time preventing unwanted side effects.

High-risk prostate cancer

Depending on the specific medical indication, TULSA-PRO is also an appropriate form of treatment for cases of high-risk prostate cancer.

Non-localized tumors in need of local intervention

Once prostate cancer has spread beyond the boundaries of the prostate (extracapsular extension) to other structures or organs, it is usually no longer possible to eliminate it entirely. The goal of localized, palliative intervention is to reduce the volume of the tumor (debulking) as much as possible to prevent further growth and avoid complications such as bleeding, urinary retention and urinary incontinence.

Owing to the precision of preliminary MRI planning and real-time intraoperative MRI monitoring, as well as the minimally invasive nature of transurethral ultrasound ablation, TULSA-PRO represents a suitable means of reducing the extent and impact of prostate cancer.

MRI as the Basis for TULSA-PRO

1. MRI scan

Multiparametric prostate MRI is the basis for the initial diagnosis of prostate cancer, as well as for planning appropriate intervention. MRI enables your doctor to ascertain the exact position and spatial extent of prostate tumors. It also provides detailed information about the prostate and its surroundings, information that is necessary for planning and performing focal TULSA-PRO treatment. At the ALTA Klinik, we use a special method of carrying out multiparametric MRI scans of the prostate that we have developed and optimized on the basis of many years of experience.

Patient G. P., 72 years old"I would give the ALTA Klinik an A+ for biopsy accuracy."

When my PSA score rose in 2015, my urologist recommended that I undergo a fusion biopsy. Fusion biopsy combines the accuracy of preoperative MRI or CT scans with intraoperative ultrasound images to guide the removal of tissue samples. Combining the MRI or CT images with the ultrasound images is thought to enable your doctor to accurately biopsy specific areas of interest in the prostate. Acting on the recommendation of my doctor, I underwent fusion biopsy at the Martini Klinik in Hamburg on January 6, 2016. After examining the 21 samples that had been removed, the pathologist concluded that there was no evidence of a tumor.

When my PSA score then rose from 5.5 to 8.0 between 2016 and 2017, my urologist recommended a Ga 68 PSMA PET/MRI examination and fusion biopsy at the Munich University Hospital. The radioactive substance permits the detection of very small tumors. The biopsy (16 tissue samples) was carried out on January 24, 2018 in Munich.

A week later, the head doctor at the hospital called to say that while the pathology report was again negative for prostate cancer, he had reviewed the MRI scans and found what he regarded as a certain tumor. And what’s more, he said that he’d compared the recent scans with the scans taken two years earlier at the Martini Klinik in Hamburg and detected what he regarded as the smaller, earlier-stage version of the same tumor!

When I asked the doctor why the biopsy hadn’t confirmed the presence of a tumor, he said that the physician who carried out the biopsy must simply have missed the target, adding that my prostate may have been compressed when the biopsy needle was inserted and might therefore have assumed a different shape, a change that can’t always be compensated for during fusion biopsy. He also said that the relatively large distance (3.2 cm) from the wall of the rectum to the tumor may also have played a role.

In the end, he advised me to wait 3 months and then return to the Martini Klinik in Hamburg, which is close to where I live, for a 4-to-6 sample biopsy targeting the location of the tumor. When I asked him what I should do if the additional procedure again failed to hit the tumor, his response was that he didn’t know what I should do.

After checking all of my records, the doctor at the Martini Klinik called me to say that he couldn’t assure me that he would be able to hit the tumor by taking another 4 to 6 samples, and that I should turn to the ALTA Klinik in Bielefeld if I wanted 100% accuracy.

At this point, I had begun to lose faith in the system. A biopsy in Hamburg, then in Munich and now in Bielefeld!? However, after having a look at the ALTA Klinik’s website and later talking to one of their staff members, I had a good feeling.

At the ALTA Klinik, I underwent an MRI-guided biopsy. The doctor inserted two biopsy needles from the buttocks to the prostate, correcting their disposition repeatedly with the help of real-time MRI until he’d perfectly aligned the needles to the middle of the tumor. Other locations were also biopsied on the basis of a template to rule out the presence of cancerous tissue. There was no pain, and there was no need to administer an antibiotic.
Result: As promised on the telephone and on the website, they had successfully targeted the tumor. And the pathologist’s examination turned up adenocarcinoma of the prostate with a Gleason score of 3+4 = 7.

Despite the bad news, I was very satisfied with the treatment at the ALTA Klinik because clarity had at long last been established and this was the basis for planning an appropriate intervention. Although the Martini Klinik in Hamburg enjoys an excellent reputation throughout Europe, the doctors there weren’t able to biopsy my tumor via fusion biopsy. Still, I credit them for their candor and for referring me to the ALTA Klinik.

In contrast, I’m completely disappointed by the staff at the Munich University Hospital. I’m virtually certain that the specialists working at major urology centers in Germany know about the reliable biopsy procedure available at the ALTA Klinik. And the head urologist there should have referred me to the ALTA Klinik. After all, my health was on the line and time had become a critical factor.

Conclusion: 
Neither the Martini Klinik in Hamburg nor the Munich University Hospital was able to successfully removing a sample of tissue from the tumor. I would give the ALTA Klinik an A+ for biopsy accuracy. Many thanks!

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2. Biopsy

If an MRI scan turns up one or more areas of interest, a biopsy is necessary to rule out or confirm the presence of prostate cancer and assess its degree of malignancy.

Our special MRI-guided prostate biopsy enables us to remove tissue samples from suspicious-looking locations in the prostate with pinpoint accuracy. In keeping with the latest guidelines for prostate biopsy in Germany, we also remove tissue samples systematically from various parts of the prostate. This of the targeted and systematic removal of tissue samples enables better detection rates than other methods alone. Moreover, with the administration of no more than local anesthesia, the procedure is painless.

Given that our biopsy proceeds under real-time MRI control – as opposed to ultrasound-guided – there is no need to insert a probe into the rectum. The removal of tissue samples proceeds neither through the rectum nor the peritoneum, but via a location near the top of the intergluteal cleft. That is why the prophylactic administration of an antibiotic is unnecessary. Once the procedure is complete, the removed tissue samples are carefully examined by our renowned pathologist.

3. Treatment

If the prerequisites are met, we recommend organ-sparing, focal TULSA-PRO treatment.

TULSA-PRO Using Outside MRI Scans

The TULSA-PRO treatment can also be carried out using the results of an outside MRI scan of the prostate, so long as the scans meet the criteria for planning the TULSA-PRO procedure. In order to make this determination, we require a CD copy of the scans along with the radiology report. If a biopsy has already been performed, we will also need a copy of the pathology report.

Our prostate therapy preserves organs and functions! We will be happy to advise you personally:

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