FOCAL TREATMENT OF PROSTATE CANCER USING FOCAL ONE DEVICE. ROLE OF FOCAL THERAPY, ONCOLOGICAL AND FUNCTIONAL RESULTS
The over-diagnosis and over-treatment of prostate cancer is a reality unequivocally demonstrated by studies with PSA screening . In fact in the United States and Canada it is a recommendation was issued against [2,3] systematic screening. In Europe, however, in agreement with the European Society of Urology, the execution of the PSA in patients without urinary symptoms it should be reserved for patients with a 15 year life expectancy and should focus particularly "cases at risk" or with a family history, hereditary or members of certain ethnic groups . Together with the re-evaluation of the role of PSA and early diagnosis of prostate cancer were introduced into clinical practice of alternative treatment modality to classical radical therapy, surgery or radiation, for low risk of progressing tumors . The need for alternatives to radical therapy derived from the heavy consequences which in fact has on the patient's quality of life when the benefits, in terms of lifespan gain, are not certain [2,3]. Active surveillance is in fact a deferred treatment of radical therapy [5,6]. The tumor is monitored by repeated checks with PSA, clinical examination of the prostate and prostate biopsies [5,6]. In about 1/3 of cases in active surveillance for a suspected progression, the patient is recommended a radical active treatment [5,6]. Until any radical treatment patients that maintain their quality of life, though psychologically accept "live" with the tumor. The evolution of multiparametric MRI, the ability to perform targeted biopsies (fusion biopsy on mpMRI)  and to identify a primary outbreak , the so-called "index lesion", within the prostate, has allowed to introduce into clinical practice the focal therapy that is substantially complementary to the active surveillance and, analogously thereto, ideal for limiting the over treatment of prostate cancer. The focal therapy is associated with a very low probability of affecting the patient's quality of life, ensuring generally the preservation of continence and sexual activity [9,10]. Nevertheless, treating the primary lesion can cure the patient and avoid potentially radical treatment for all the rest of life .
Materials and Methods
Focal One is a device designed for the focal therapy of Prostate Cancer integrating the ability to visualize, target, treat and validate the focal treatment. Magnetic Resonnance Imaging (MRI) volumes are imported through the hospital’s network into the device so that an elastic fusion can be done between the real time ultrasonography and the MRI where the regions to treat have been previousy drawn, thus allowing to apply limited and targeted HIFU lesions. During the HIFU energy delivery process, the operator sees a live ultrasound image of what is being treated and, if necessary, can readjust the treatment planning. At the end of the treatment process, a Contrast-enhanced Ultrasound volume is acquired showing the de-vascularized areas.
53 patients with mono focal prostate cancer were treated from June 2015 and January 2017.HIFU treatment process was realized with the Focal One device using a 6to 12 mm safety margin around the tumor. Contrast enhanced MRI is performed within 30 day after HIFU and Control biopsies with fusion technique were performed only on suspected mri lesion.
All patients respected inclusion criteria:
Life expectancy ≥10 years
PSA at diagnosis ≤15,
clinical stage cT2NoMo
cancerous lesions identified at mpMRI
Biopsy performed with technical cast of mpMRI image with histopathological positive concordant with suspects mpMRI
Standard cancer biopsy but with acknowledgment to mpMRI (also later executed) and contralateral lobe to mpMRI negative and / or positive in one frustule to 3 mm max
Gleason score 3 + 3 (grade group 1)
presence of tumor for more than 3 mm in the frustule bioptic
presence of cancer in at least two biopsy cores,
cancer mpMRI> ≥10mm
Gleason score 3 + 4 (grade group 2)
Gleason score 4 + 3 (grade 3 group) as a single index lesion or lesion associated depending on the same side or contralateral lesion grade group 1 and 2 present in a frustule only for a maximum of 3 mm
The mean age of patients was 65.8±5.5 years. Mean cancer volume was 9 cc (6 to 15 cc)
Mean Prostate Volume was 40±23 cc and no patient required TURP before procedure
Average time of procedure 50 min
Mean Time of Hospitalization 2 Days
Average time of catheterization 5 Days.
none found major postoperative complication
>95% of preservation of continence
>75% of the power preservation
<15% failure rate
The over treatments era is finished, the technologies (MRI multi parametric , fusion biopsy) let us to chose patients witch can switch to Active surveillance ore active focal treatments without having to undergo to surgery as first therapy line. Since the early 2000s, two systems have been marketed for this application, and other devices are currently in clinical trials. HIFU treatment can be used either alone or in combination with (before- or after-) external beam radiotherapy (EBRT) (before or after HIFU) and can be repeated multiple times. HIFU treatment is performed under real-time monitoring with ultrasound or guided by MRI.
We must look to the past: HISTORICAL INFORMATION FROM PUBLIC WITH HIFU [12-28]
With radical curative intent in prostate cancer confined to the gland or locally advanced
Age greater than or equal to 70 years
Age also less than 70 years in the presence of significant comorbidities
Refusal by the patient of the other standard treatments provided by international guidelines (RT, radical prostatectomy, active surveillance)
Local recovery of established disease with biopsy after RT, brachytherapy or radical prostatectomy.
With palliative intent,HIFU may be indicated even in prostate tumors become hormonotherapy resistant and how local therapy minimally invasive cytoreductive within prostate tumors in metastatic systemic therapy.
Only turning his eyes back we will look to the future (29-32)
– only treat the micro tumor foci saving the prostate gland and thus improving% of urinary incontinence and erectile dysfunction. The focal treatment therefore involves the ablation of prostatic tumor lesion that has the highest biopsy Gleason Score or the biggest volume (Index Tumor IT). Consensus not to preclude the therapy for multifocal tumors.
In the recent past the focal therapy had limitations due to the variability and validity of biopsy mapping; currently with the introduction of Magnetic Resonance Multiparametric and "fusion imaging" that is, the integration of the images obtained by multiparametric MRI and 3D ultrasound was made a major scientific advancement for both diagnosis and for the indications to treat cancer prostate.
-Zonal (more tissue treatment than the focal)
-Emiablazione (1/2 prostate; right or right lobe)
-Multi-zone (both right quadrants that sin, not total)
HIFU is an evolving technology perfectly adapted for focal treatment. Thus, HIFU focal therapy is another pathway that must be explored when considering the accuracy and reliability for PCa mapping techniques. HIFU would be particularly suited for such a therapy since it is clear that HIFU outcomes and toxicity are relative to the volume of prostate treated. Focal One device is able to achieve a complete destruction of small prostate cancer using an elastic magnetic resonance-ultrasound (MR-US) registration system for tumor location and HIFU treatment planning.
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