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Ablatherm® HIFU clinical publications

2013: Evolution and Outcomes of 3 MHz High Intensity Focused Ultrasound Therapy for Localized Prostate Cancer During 15 Years

Stefan Thüroff and Christian Chaussy - © 2013 The Journal of Urologyn, Vol. 190, 702-710, August 2013

The results in 704 patients show that HIFU offers men with localized PCa a standardized reliable therapy with a low rate of perioperative comorbidity, an absence of serious morbidity and sufficient cancer control such that salvage therapy was not required at 10-year followup by 99%, 72% and 68% of low, intermediate and high risk patients, respectively, which is particularly important from a patient centered perspective. PSA nadir was demonstrated to be the greatest predictor of biochemical failure and the median PSA nadir has been 0.1 ng/ml or less since 2000. PSA velocity was less than 0.1 ng/ml but not zero, resulting in a slow increase to a PSA of 0.29 ng/ml at 5 years. The 95% metastasis-free survival rate at 10 years excludes TURP as a factor in metastatic spread in patients with localized prostate cancer and represents the first published data to our knowledge that empirically refute this long held assumption. Combined with TUR, HIFU can provide low invasive complete local tumor ablation, substituting surgery/cryotherapy or postponing radiation therapy or/and long-term ADT in elderly patients. The presented data of 10-year outcomes may warrant the possible closing of the investigational phase of HIFU.

 

2013: Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer

Roman Ganzer et al - © 2013 BJU International | doi:10.1111/j.1464-410X.2012.11715.x

In conclusion, we report on a large consecutive patient series after primary HIFU for clinically localized PCa with the longest follow-up in current literature. Our results improve the understanding of the oncological efficacy, morbidity and side effects of primary HIFU. The study underlines that HIFU is a therapeutic option for patients of advanced age, at low-to-intermediate risk and with a life expectancy of ~10 years. The rate of serious side effects such as recto-urethral fistulae is low.

 

2013: Whole-gland Ablation of Localized Prostate Cancer with High-intensity Focused Ultrasound: Oncologic Outcomes and Morbidity in 1002 Patients

Sebastien Crouzet et al. - European Urology http://dx.doi.org/10.1016/j.eururo.2013.04.039

A total of 1002 patients were included. At 10 yr, the PCa-specific survival rate and metastasis-free survival rate (MFSR) were 97% and 94%, respectively. Salvage therapies included external-beam radiation therapy (EBRT) (13.8%), EBRT plus androgen-deprivation therapy (ADT) (9.7%), and ADT alone (12.1%). Severe incontinence and bladder outlet obstruction decreased with refinement in the technology, from 6.4% and 34.9% to 3.1% and 5.9%, respectively. HIFU is a minimally invasive therapeutic option with encouraging cancer-specific survival rates in patients with localized PCa. The 10-yr PCSMs and MFSRs were low, and the morbidity was acceptable. Salvage EBRT for post-HIFU relapse was feasible, and the rate of patients requiring palliative ADT was low.

 

2012: Complete high-intensity focused ultrasound in prostate cancer: outcome from the @-Registry

Andreas Blana et al - Prostate Cancer and Prostatic Diseases

"Complete prostate-gland HIFU as primary monotherapy for localized prostate cancer is effective oncologically in a subset of patients with small prostate as measured by post-therapy prostate biopsy and serum PSA endpoints. In this study, HIFU is equally efficacious for all the grades of prostate cancer on short-term follow-up. Careful evaluation of long-term HIFU efficacy is needed and should be compared with established therapies with a complete HIFU approach to allow the most accurate evaluation of this promising and novel technology."

 

2012: Single-session primary high-intensity focused ultrasonography treatment for localized prostate cancer: biochemical outcomes using third generation-based technology.

Jehonathan H. Pinthuset al - BJUI

"In conclusion, 4-year oncological efficacy of single-session primary HIFU is promising in patients with low- and intermediate-risk PC. Most cases of BCF occur in the first 2 years and are progressively less common thereafter within the timeline of study. Patients with low- and intermediate-risk PC who achieve a PSA nadir < 0.5 ng/mL have excellent 4-year biochemical failure free progression after a single session of primary HIFU therapy. A prostate volume < 30 mL is associated with PSA nadir levels of < 0.5 ng/mL which raises the question of whether planned pretreatment prostate volume reduction (medically or surgically) should be considered in larger prostates."

 

 

2012: Single application of high-intensity focused ultrasound as a first-line therapy for clinically localized prostate cancer: 5-year outcomes.

Dietrich Pfeifferet al - BJUI

"Single-session HIFU is recommended as a curative approach in elderly patients with low-risk PCa. Patients at higher risk of tumour progression should be counseled regarding the likely need for salvage therapy, including repeat HIFU."

 

2011 : Robotic High-intensity Focused Ultrasound for Prostate Cancer: What Have We Learned in 15 Years of Clinical Use?

Christian Chaussy et al - Current Urology Report 2011

"Since 2000, HIFU by Ablatherm is a nonexperimental therapy under long-term investigation for primary treatment of local prostate cancer as well as salvage therapy after radiation failure. It appears to have a high potential to treat on either side of this spectrum in focal and in incidental prostate cancer as well as adjuvant in T3/T4 disease or in nonmetastatic hormone-resistant prostate cancer. The versatility of HIFU appears to be unique in the treatment of the entire spectrum of prostate cancer, which is a multifaceted increasing and long-lasting disease. HIFU does not substitute or is not competitive to only one classical therapy, but its indications overlap in a certain range with all therapies. As additional local one-session tumor debulking therapy..."

 

2011 : Focal Therapy with High-Intensity Focused Ultrasound for Prostate Cancer in the Elderly. A Feasibility Study with 10 Years Follow-Up.

Amine B. El Fegoun et al - Brazilian Journal of Urology 2011

" This retrospective feasibility study shows that hemi-prostate ablation with HIFU is a reasonable treatment strategy for a selected population of low or intermediate risk prostate cancer in elderly men. The long-term cancer control rate is adequate, recurrences can be treated with a second HIFU session or other techniques. In the elderly, the concept of cancer control instead of cancer cure with HIFU has to be discussed, as it seems to provide an effective longterm disease control with minimal treatment-related morbidity. More extensive biopsy protocols and more accurate imaging techniques will certainly improve patients’ selection. Larger prospective studies with a long follow-up are awaited to confirm our small size preliminary results."

 

2011 : HIFU as salvage fi rst-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer after radical prostatectomy: A pilot study

Anastasios D. Asimakopoulos et al – Urologic Oncology 2011

"HIFU as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP is a feasible, minimally invasive day-case procedure, with an acceptable morbidity profile. It seems to have good cancer control in the short- and mid-term. Patients with lower pre-HIFU PSA level and favorable pathologic Gleason score seem to present better oncologic outcomes. A prospective randomized trial with an adequate recruitment and follow-up is necessary to confirm our preliminary oncologic results."

 

2011 : Correlation of prostate-specific antigen nadir and biochemical failure after High-Intensity Focused Ultrasound of localized prostate cancer based on the Stuttgart failure criteria – analysis from the @-Registry.

Roman Ganzer et al – BJU International 2011

"This multicentre analysis confirms that PSA nadir after HIFU predicts biochemical DFSR in a statistically significant manner."

 

2010 - 03 : Multicentric Oncologic Outcomes of High-Intensity Focused Ultrasound for Localized Prostate Cancer in 803 Patients

Sebastien Crouzet, Department of Urology, Edouard Herriot Hospital, Lyon, France

EurUrol(2010),doi:10.1016/j.eururo.2010.06.037

"Local control and DFSR achieved with HIFU were similar to those expected with conformal external-beam radiation therapy(EBRT).The excellent cancer-specific survival rate is also explained by the possibility to repeat HIFU and use salvage EBRT."

 

2010 - 02 : Salvage Radiotherapy After High-Intensity Focussed Ultrasound for Recurrent Localised Prostate Cancer

Julien Riviere et al., Urology Department,Hôpital UniversitairePellegrin,Bordeaux,France

Eur Urol 2010),doi:10.1016/j.eururo.2010.06.003

 

 

 

2010 - 01 : A prospective study of salvage high-intensity focused ultrasound for locally radiorecurrent prostate cancer: Early results

VIKTOR BERGE et al. Department of Urology, Oslo University Hospital, Aker, Oslo, Norway - Scandinavian Journal of Urology and Nephrology, 2010; Early Online, 1-5

 

 

2008 – 03 : First Analysis of the Long-Term Results with Transrectal HIFU in Patients with Localised Prostate Cancer

Andreas Blana et al. 2007 European Urology 2271 article in press

"This study demonstrates the effective long-term cancer control achieved using HIFU in patients with low- or intermediate-risk localised prostate cancer. We belived HIFU provides a potential treatment option for localised prostate cancer in patients who are not eligible for surgery. The additional benefit of a favourable morbidity profile should persuade clinicians to consider more patients for this curative option, which is, in our opinion, a valid alternative to radiotherapy."

 

 

2008 – 02 : High-intensity focused ultrasound in prostate cancer; a systematic literature review of the French Association of Urology

Xavier Rebillard**Clinique Beau Soleil, Montpellier et al. BJU International 2008 1464-410X.2008.07504.x

"In patients selected [...], HIFU results in short-term cancer control, as shown by a high percentage of negative biopsies and substantially decreased PSA levels. Median-term DFS data (with the Ablatherm device) seem promising. With the continuous development of the Ablatherm device and the use of TURP before HIFU, the rate of HIFU-related complications has decreased. Recent studies show that HIFU is well tolerated, with a low rate of complications that compare favourably with those after established therapies. Longer-term follow-up studies are needed to further evaluate cancer-specific and overall survival rates."

 

 

2008 - 01 : Mid-term Results Demonstrate Salvage High-Intensity Focused Ultrasound (HIFU) as an Effective and Acceptably Morbid Salvage Treatment Option for Locally Radiorecurrent Prostate Cancer

François-Joseph Murat et al. 2008 European Urology, doi:10.1016/j.eururo.2008.04.091

"Salvage HIFU is a promising treatment option for local relapse after RT failure. This retrospective analysis shows high local tulour control. Favourable 5-yr outcomes are expected if HIFU is performed for low-risk or intermediate-risk patients. There are acceptable morbidity rates and especially nu URF with the specific post-radiation parameters. [...] Future advances in technology and safety will undoubtely expand the HIFU role in this indication.

 

 

2007 – 01 : Factors Predicting for Formation of Bladder Outlet Obstruction After High-Intensity Focused Ultrasound in Treatment of Localized Prostate Cancer

Andreas Blana et al. 2007 Journal of Urology 2007.12.076 Article in Press

"In our study, the occurrence of BOO after HIFU was significantly associated statistically with older age. Surprisingly, TURP before HIFU was not an independent factor in the prevention of BOO during follow-up. However, the occurence of multiple BOO episodes could be reduced by resecting more tissue with TURP before HIFU."

 

2006 – 07 : High Intensity Focused Ultrasound for Prostate Cancer: A Review of the Scientific Foundation, Technology and Clinical Outcomes

John C. Rewcastle, Ph.D., Department of Radiology, University of Calgary, Canada
Technology in Cancer Research and Treatment, Vol. 5, Number 6, December 2006, 619-625

"High intensity focused ultrasound is a technologically advanced non-invasive therapy for prostate cancer. There currently exist two commercially available treatment units each with their own merits. Longer follow-up is available with the Ablatherm device, which also has demonstrated high local disease control in multicenter investigations. The role of HIFU will continue to be defined as more patient series are published with longer term follow-up."

 

2006 – 06 : Short-term outcome after high-intensity focused ultrasound in the treatment of patients with high-risk prostate cancer

Vincenzo Ficarra, 2006 BJU International, 98, 1193-1198

"HIFU is a minimally invasive therapy for prostate cancer ofter used in selected patients with localized disease. The present results showed that HIFU combined with adjuvant pharmacological castration was feasible also in patients with high-risk prostate cancer. The low complication rates, favourable functional outcome and particularly the promising preliminary oncological data support the planning of further larger studies in such patients. The oncological efficacy of the present protocol should be assessed in further studies with more patients and a longer follow-up."

 

2006 – 05 : Recurrent Prostate Cancer After Radiotherapy – Salvage Treatment by High Intensity Focused Ultrasound

F-J. Murat,L. Poissonnier, A. Gelet, Hôpital Edouard Herriot, Lyon, France European Oncological Disease, Sept. 2006, 64-66

"Treatment with HIFU allowed local tumour control in 84% of patients treated for prostate cancer recurrence after radiotherapy, but disease control depended on initial risk factor and Gleason score at the time of recurrence. High-risk patients (T3 or PSA >20 or Gleason score ≥8) are not good candidates for salvage treatment with HIFU: they must be strictly selected (18F-fluorocholine PET scan) as the majority have silent metastases associated with local recurrence. Conversely, treatment with HIFU is a very interesting curative option for low- or intermediate-risk patients, particularly if the Gleason score of the local recurrence is ≤7."

 

2006 – 04 : Control of Prostate Cancer by Transrectal HIFU in 227 Patients

Laura Poissonnier. Eur Urol. 2006 May 2

"Transrectal HIFU is a minimally invasive therapy that controled localized prostate cancer locally in 86% of the cases. This therapy provided disease control in 66% of the patients with clinically confined prostate cancer. Early feedback on treatment efficacy was gained by using nadir PSA (obtained within 4 months) and random control biopsies."

 

2006 – 03 :High-intensity focused ultrasound therapy for clinically localized prostate cancer

HM Lee, JH Hong and HY Choi. Prostate Cancer and Prostatic Diseases (2006), 1-5 .

 

2006 – 02 : Morbidity associated with repeated transrectal high-intensity focused ultrasound treatment of localized prostate cancer

Andreas Blana, Sebastian Rogenhofer, Roman Ganzer, Peter J. Wild, Wolf F. Wieland, Bernhard Walter. World J Urol. 2006 Jul 19

"Additional HIFU treatments in case of primary treatment failure for patients with localized prostate cancer are associated with only a minor increase in morbidity.However the forthcoming aim will be to lower the rate of patients with residual cancer after initial HIFU treatment by refined patient selection and more effective treatment modalities."

 

2006 – 01 : HIFU: Local Treatment of Prostate Cancer

H. Azzouz, J.J.M.C.H. de la Rosette. EAU-EBU update series 4, 2006, 62-70

"HIFU has proven mid-term high local and biochemical efficacy in patients with local confined prostate cancer. A HIFU also shows promising results in local recurrence of prostate cancer after external beam radiation."

 

2005 – 03 : Treatment of Localised Prostate Cancer with Transrectal High-intensity Focused Ultrasound

G. Vallacien
European Kidney & Urological Disease, Nov. 2005, 61-62

2005 – 02 : Transrectal High Intensity Focused Ultrasound in the Treatment of Localized Prostate Cancer
X. Rebillard (1), A. Gelet (2), J.L. Davin (3), M. Soulie (4), D. Prapotnich (5), X. Cathelineau (5), F. Rozet (5), G. Vallancien (5). (1) Clinique Beau Soleil, Montpellier, France, (2) Dpt of Urology, Edouard Herriot Hospital, Lyon, France, (3) Clinique Rhône Durance, Avignon, France, (4) CHU Rangueil, Toulouse, France, (5) Institut Mutualiste, Paris, France.
Journal of Endourology, Vol. 19, No. 6, p. 693-701, July/August 2005

 

2005 – 01 : Technology Insight: High Intensity Focused Ultrasound for Urologic Cancers

C. Chaussy (1), S. Thüroff (1), X. Rebillard (2), A. Gelet (3). (1) Dpt of Urology, University Hospital of Munich-Harlaching, Germany. (2) Clinique Mutualiste Beausoleil, Montpellier, France. (3) Dpt of Urology, Edouard Herriot Hospital, Lyon, France.
NATURE Clinical Practice Urology, Vol. 2, No. 4, p. 191-198, April 2005

2004 – 02 : Local Recurrence of Prostate Cancer after External Beam Radiotherapy: Early Experience of Salvage Therapy using High-Intensity Focused Ultrasonography
A. Gelet, J.Y. Chapelon, L. Poissonnier, R. Bouvier, O. Rouvière, L. Curiel, M. Janier, G. Vallancien, Hôpital Edouard Herriot, Dept. of Urology, Lyon, Institut Montsouris, Dept. of Urology, Paris, France.
Urology 63 (4), p. 625-629, April 2004

 

2004 – 01 : High Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer: 5-year Experience

A. Blana, B. Walter, S. Rogenhofer, W.F. Wieland, University of Regensburg, Dept. of Urology, Germany.
Urology 63 (2), p. 297-300, 2004

 

2003 – 02 :High-Intensity Focused Ultrasound and Localized Prostate Cancer: Efficacy Results from the European Multicentric Study

S. Thüroff(1), C. Chaussy (1), G. Vallancien (2), W. Wieland (3), H.J. Kiel (3), A. Le Duc (4), F. Desgrandchamps (4), J. De La Rosette (5), A. Gelet (6). Munich-Harlaching University, München, Germany (1) - Institut Mutualiste Montsouris, Paris, France (2) - Caritas Krankenhaus, Regensburg, Germany (3) - Hôpital Saint-Louis, Paris, France (4) - University Medical Center St Radboud, Nijmegen, The Netherlands (5) - Hôpital Edouard Herriot, Lyon, France (6).
Journal of Endourology, Volume 17, Number 8, October 2003

 

2003 – 01 : The Status of High-Intensity Focused Ultrasound in the Treatment of Localized Prostate Cancer and the Impact of a Combined Resection

C. Chaussy, S. Thüroff, Munich-Harlaching University, Germany.
Current Urology Reports, Volume 4, Issue 3, 2003

 

2001 – 01 : Transrectal High-Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer: Factors Influencing the Outcome

A. Gelet, J.Y. Chapelon, R. Bouvier, O. Rouvière, D. Lyonnet, J.M. Dubernard. Edouard Herriot Hospital, Lyon, France.
European Urology, 2001; 40:124-129

 

2000 – 01 : Transrectal High-Intensity Focused Ultrasound: Minimally Invasive Therapy of Localized Prostate Cancer

A. Gelet, J.Y. Chapelon, R. Bouvier, O. Rouvière, Y. Lasne, D. Lyonnet, J.M.Dubernard. Edouard Herriot Hospital, Lyon, France.
Journal of Endourology, Volume 14, Number 6, August 2000

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