==inizio objective==
The over-diagnosis and over-treatment of prostate cancer is a reality unequivocally demonstrated by studies with PSA screening [1]. 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 [4]. 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 [4]. 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) [7] and to identify a primary outbreak [8], 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 [11].
==fine objective==
==inizio methodsresults==
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
==fine methodsresults==
==inizio results==
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
==fine results==
==inizio discussions==
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)
Focal therapy
- 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)
==fine discussions==
==inizio conclusion==
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.
==fine conclusion==
==inizio reference==
1)Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up.
Schröder FH et all ERSPC Investigators.Lancet. 2014 Dec 6;384(9959):2027-35
2)Moyer VA; U.S. Preventive Services Task Force.Screening for prostate cancer: U.S. Preventive ServicesTask Force recommendation statement. Ann Intern Med2012;157:120-34.Canadian Task Force on Preventive Health Care, Bell N,
3)Connor Gorber S, et al. Recommendations on screening or prostate cancer with the prostate-specific antigen test. CMAJ 2014;186:1225-34.
EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der 4)Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology Eur Urol. 2014 Jan;65(1):124-37.
5)Klotz L, Zhang L, Lam A, et al. Clinical results of longterm follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol 2010;28:126-31
6)Bul M, Zhu X, Valdagni R, et al. Active surveillance for low-risk prostate cancer worldwide: the PRIAS study. Our Urol 2013;63:597-603
7)Assessment of Prospectively Assigned Likert Scores for Targeted Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Biopsies in Patients with Suspected Prostate Cancer. Costa DN, Lotan Y, Rofsky NM, Roehrborn C, Liu A, Hornberger B, Xi Y, Francis F, Pedrosa I. J Urol. 2016 Jan;195(1):80-7.
8)Multiparametric Magnetic Resonance Imaging (MRI) and MRI-Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen. Radtke JP, Schwab C, Wolf MB, Freitag MT, Alt CD, Kesch C, Popeneciu IV, Huettenbrink C, Gasch C, Klein T, Bonekamp D, Duensing S, Roth W, Schueler S, Stock C, Schlemmer HP, Roethke M, Hohenfellner M, Hadaschik BA. Eur Urol. 2016 Jan 19
9)Marien A, Gill I, Ukimura O, Betrouni N, Villers A. Target ablation— image-guided therapy in prostate cancer. Urol Oncol 2014;32: 912–23.
10)Valerio M, Ahmed HU, Emberton M, et al. The role of ocal therapy in the management of localised prostate cancer: a systematic review. Eur Urol 2014;66:732-51.
11)The Effects of Focal Therapy for Prostate Cancer on Sexual Function: A Combined Analysis of Three Prospective Trials. Yap T, Ahmed HU, Hindley RG, Guillaumier S, McCartan N, Dickinson L, Emberton M, Minhas S Eur Urol. 2015 Oct 30
12)Whole-gland Ablation of Localized Prostate Cancer with High-intensity Focused Ultrasound: Oncologic Outcomes and Morbidity in 1002 Patients. S. Crouzet et al - 2013 - European Urology
13)Evolution and Outcomes of 3 MHz High Intensity Focused Ul- trasound Therapy for Localized Prostate Cancer During 15 Years.
S. Thüroff et al - 2013 The Journal of Urology
14)Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer.
R. Ganzer et al - 2013 BJU International
15)Locally recurrent prostate cancer after initial radiation therapy: Early sal- vage high-intensity focused ultrasound improves oncologic outcomes. S. Crouzet et al - Radiother Oncol. 2012
16)Single application of high-intensity focused ultrasound as a rst-line therapy for clinically localized prostate cancer: 5-year outcomes. D. Pfeiffer et al - 2012 BJU International
17)Morbidity of Focal Therapy in the Treatment of Localized Prostate Cancer.
E. Barret et al - 2012 BJU International
18)High-intensity focused ultrasound (HIFU) for de nitive treatment of pros- tate cancer. E. R. Cordeiro et al - 2012 BJU International
19)Complete high-intensity focused ultrasound in prostate cancer: outcome from the @-Registry. A. Blana et al - 2012 Prostate Cancer and Prostatic Diseases
20)Single-session primary high-intensity focused ultrasonography treatment for localized prostate cancer: biochemical outcomes using third genera- tion-based technology. J. H. Pinthus et al - 2012 BJU International
21)Robotic High-intensity Focused Ultrasound for Prostate Cancer: What Have We Learned in 15 Years of Clinical Use? C. Chaussy et al - Current Urology Report 2011
22)Foca al Therapy with High-Intensity Focused Ultrasound for Pros- tate Cancer in the Elderly. A Feasibility Study with 10 Years Follow-Up. A. B. El Fegoun et al - Brazilian Journal of Urology 2011
23)HIFU as salvage rst-line treatment for palpable, TRUS-evidenced, biop- sy-proven locally recurrent prostate cancer after radical prostatectomy: A pilot study. A. Asimakopoulos et al – Urologic Oncology 2011
24)Correlation of prostate-speci c antigen nadir and biochemical failure after High-Intensity Focused Ultrasound of localized prostate cancer based on the Stuttgart failure criteria – analysis from the @-Registry. R. Ganzer et al – BJU International 2011
25)Multicentric Oncologic Outcomes of High-Intensity Focused Ultrasound for Localized Prostate Cancer in 803 Patients. S. Crouzet et al - 2010 European Urology
26)Salvage Radiotherapy After High-Intensity Focussed Ultrasound for Recur- rent Localised Prostate Cancer. J. Riviere et al - 2010 European Urology
27)A prospective study of salvage high-intensity focused ultrasound for lo- cally radiorecurrent prostate cancer: Early results. V. Berge et al - 2010 Scandi- navian Journal of Urology
28)High-intensity focused ultrasound in prostate cancer; a systematic literature review of the French Association of Urology. X. Rebillard et al - BJU International 2008
29)Eight years’ experience with High-Intensity Focused Ultrasonography for treatment of localized prostate cancer. A. Blana et al Journal of Urology 2008.06.062
30)Comparing High-Intensity Focal Ultrasound Hemiablation to Robotic Radical Prostatectomy in the Management of Unilateral Prostate Cancer: A Matched-Pair Analysis.
Albisinni S, Aoun F, Bellucci S, Biaou I, Limani K, Hawaux E, Peltier A, van Velthoven R.
J Endourol. 2017 Jan;31(1):14-19.
31)Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients.
Rischmann P, Gelet A, Riche B, Villers A, Pasticier G, Bondil P, Jung JL, Bugel H, Petit J, Toledano H, Mallick S, Rouvière O, Rabilloud M, Tonoli-Catez H, Crouzet S.
Eur Urol. 2017 Feb;71(2):267-273.
32)Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes.
Feijoo ER, Sivaraman A, Barret E, Sanchez-Salas R, Galiano M, Rozet F, Prapotnich D, Cathala N, Mombet A, Cathelineau X.
Eur Urol. 2016 Feb;69(2):214-20
==fine reference==