Clinical Research

A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer

Abstract

Background:

Focal therapy is an emerging mini-invasive treatment modality for localized prostate cancer aimed to reduce the morbidity associated with radical therapy while maintaining optimal cancer control. We report the mid-term oncological and functional results of primary hemiablation high-intensity focused ultrasound (HIFU) in a prospective cohort of patients.

Methods:

Over 8 years, hemiablation HIFU was primarily performed in 50 selected patients with biopsy-proven clinically localized unilateral, low–intermediate risk prostate cancer in complete concordance with the prostate cancer lesions identified by magnetic resonance imaging with precise loci matching on multimodal approach. Post-treatment follow-up included regular serial PSA measurements. Biochemical recurrence was reported using Stuttgart and Phoenix criteria. The latter was used as a threshold to offer whole-gland biopsies.

Results:

Complete follow-up was available for all patients and the median follow-up was 39.5 months (range: 6–94). Mean nadir PSA value was 1.6 ng ml−1, which represents 72% reduction compared with initial PSA pre-treatment value (P<0.001). Median time to achieve PSA nadir was 3 months. Biochemical recurrence, according to Phoenix and Stuttgart definition, occurred in 28 and 36% of patients, respectively. The 5-year actuarial metastases-free survival, cancer-specific survival and overall survival rates were 93, 100 and 87%, respectively. Out of the eight patients undergoing biopsy, six patients had a positive biopsy for cancer occurring in the untreated contralateral (n=3) or treated ipsilateral lobe (n=1) or bilaterally (n=2). A Clavien–Dindo grade 3b complication occurred in two patients. Complete continence (no pads) and erection sufficient for intercourse were documented in 94 or 80% of patients, respectively.

Conclusion:

Hemiablation HIFU therapy, delivered with intention to treat, for carefully selected patients affords mid-term promising functional and oncological outcomes. The effectiveness of this technique should be now compared with whole-gland radical therapy.

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References

  1. 1

    Roehl KA, Antenor JA, Catalona WJ . Serial biopsy results in prostate cancer screening study. J Urol 2002; 167: 2435–2439.

    Article  PubMed  Google Scholar 

  2. 2

    Roehl KA, Antenor JA, Catalona WJ . Robustness of free prostate specific antigen measurements to reduce unnecessary biopsies in the 2.6 to 4.0 ng/ml range. J Urol 2002; 168: 922–925.

    Article  PubMed  Google Scholar 

  3. 3

    Ahmed HU . The index lesion and the origin of prostate cancer. N Engl J Med 2009; 361: 1704–1706.

    CAS  Article  PubMed  Google Scholar 

  4. 4

    Liu W, Laitinen S, Khan S, Vihinen M, Kowalski J, Yu G et al. Copy number analysis indicates monoclonal origin of lethal metastatic prostate cancer. Nat Med 2009; 15: 559–565.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  5. 5

    Beerlage HP, van Leenders GJ, Oosterhof GO, Witjes JA, Ruijter ET, van deKaa CA et al. High-intensity focused ultrasound (HIFU) followed after one to two weeks by radical retropubic prostatectomy: results of a prospective study. Prostate 1999; 39: 41–46.

    CAS  Article  PubMed  Google Scholar 

  6. 6

    Biermann K, Montironi R, Lopez-Beltran A, Zhang S, Cheng L . Histopathological findings after treatment of prostate cancer using high-intensity focused ultrasound (HIFU). Prostate 2010; 70: 1196–1200.

    Article  PubMed  Google Scholar 

  7. 7

    Ryan P, Finelli A, Lawrentschuk N, Fleshner N, Sweet J, Cheung C et al. Prostatic needle biopsies following primary high intensity focused ultrasound (HIFU) therapy for prostatic adenocarcinoma: histopathological features in tumour and non-tumour tissue. J Clin Pathol 2012; 65: 729–734.

    Article  PubMed  Google Scholar 

  8. 8

    Dickinson L, Hu Y, Ahmed HU, Allen C, Kirkham AP, Emberton M et al. Image-directed, tissue-preserving focal therapy of prostate cancer: a feasibility study of a novel deformable magnetic resonance-ultrasound (MR-US) registration system. BJU Int 2013; 112: 594–601.

    Article  PubMed  PubMed Central  Google Scholar 

  9. 9

    Valerio M, Ahmed HU, Emberton M, Lawrentschuk N, Lazzeri M, Montironi R et al. The role of focal therapy in the management of localised prostate cancer: a systematic review. Eur Urol 2014; 66: 732–751.

    Article  PubMed  PubMed Central  Google Scholar 

  10. 10

    Van Velthoven R, Aoun F, Limani K, Narahari K, Lemort M, Peltier A . Primary zonal high intensity focused ultrasound for prostate cancer: results of a prospective phase iia feasibility study. Prostate Cancer 2014; 2014: 756189.

    PubMed  PubMed Central  Google Scholar 

  11. 11

    Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss M et al. Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol 2012; 61: 341–349.

    Article  PubMed  Google Scholar 

  12. 12

    Ripert T, Azemar MD, Menard J, Barbe C, Messaoudi R, Bayoud Y et al. Six years' experience with high-intensity focused ultrasonography for prostate cancer: oncological outcomes using the new 'Stuttgart' definition for biochemical failure. BJU Int 2011; 107: 1899–1905.

    Article  PubMed  Google Scholar 

  13. 13

    Roach M 3rd, Hanks G, Thames H Jr, Schellhammer P, Shipley WU, Sokol GH et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 2006; 65: 965–974.

    Article  PubMed  Google Scholar 

  14. 14

    Singh PB, Anele C, Dalton E, Barbouti O, Stevens D, Gurung P et al. Prostate cancer tumour features on template prostate-mapping biopsies: implications for focal therapy. Eur Urol 2014; 66: 12–19.

    Article  PubMed  PubMed Central  Google Scholar 

  15. 15

    Bahn D, de Castro Abreu AL, Gill IS, Hung AJ, Silverman P, Gross ME et al. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol 2012; 62: 55–63.

    Article  PubMed  Google Scholar 

  16. 16

    Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M et al. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol 2012; 13: 622–632.

    Article  PubMed  PubMed Central  Google Scholar 

  17. 17

    El Fegoun AB, Barret E, Prapotnich D, Soon S, Cathelineau X, Rozet F et al. Focal therapy with high-intensity focused ultrasound for prostate cancer in the elderly. A feasibility study with 10 years follow-up. Int Braz J Urol 2011; 37: 213–219.

    Article  PubMed  Google Scholar 

  18. 18

    Murat FJ, Poissonnier L, Rabilloud M, Belot A, Bouvier R, Rouviere O et al. Mid-term results demonstrate salvage high-intensity focused ultrasound (HIFU) as an effective and acceptably morbid salvage treatment option for locally radiorecurrent prostate cancer. Eur Urol 2009; 55: 640–647.

    Article  PubMed  Google Scholar 

  19. 19

    Ahmed HU, Freeman A, Kirkham A, Sahu M, Scott R, Allen C et al. Focal therapy for localized prostate cancer: a phase I/II trial. J Urol 2011; 185: 1246–1254.

    CAS  Article  PubMed  Google Scholar 

  20. 20

    Nguyen PL, Chen MH, Zhang Y, Tempany CM, Cormack RA, Beard CJ et al. Updated results of magnetic resonance imaging guided partial prostate brachytherapy for favorable risk prostate cancer: implications for focal therapy. J Urol 2012; 188: 1151–1156.

    Article  PubMed  PubMed Central  Google Scholar 

  21. 21

    Wise AM, Stamey TA, McNeal JE, Clayton JL . Morphologic and clinical significance of multifocal prostate cancers in radical prostatectomy specimens. Urology 2002; 60: 264–269.

    Article  PubMed  PubMed Central  Google Scholar 

  22. 22

    Noguchi M, Stamey TA, McNeal JE, Nolley R . Prognostic factors for multifocal prostate cancer in radical prostatectomy specimens: lack of significance of secondary cancers. J Urol 2003; 170: 459–463.

    Article  PubMed  Google Scholar 

  23. 23

    Peltier A, Aoun F, Lemort M, Kwizera F, Paesmans M, Van Velthoven R . MRI-targeted biopsies versus systematic transrectal ultrasound guided biopsies for the diagnosis of localized prostate cancer in biopsy naive men. Biomed Res Int 2015; 2015: 571708.

    Article  PubMed  PubMed Central  Google Scholar 

  24. 24

    Numao N, Yoshida S, Komai Y, Ishii C, Kagawa M, Kijima T et al. Usefulness of pre-biopsy multiparametric magnetic resonance imaging and clinical variables to reduce initial prostate biopsy in men with suspected clinically localized prostate cancer. J Urol 2013; 190: 502–508.

    Article  PubMed  Google Scholar 

  25. 25

    van der Poel H, Klotz L, Andriole G, Azzouzi AR, Bjartell A, Cussenot O et al. Role of active surveillance and focal therapy in low- and intermediate-risk prostate cancers. World J Urol 2015; 33: 907–916.

    CAS  Article  PubMed  Google Scholar 

  26. 26

    Mouraviev V, Villers A, Bostwick DG, Wheeler TM, Montironi R, Polascik TJ . Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int 2011; 108: 1074–1085.

    Article  PubMed  Google Scholar 

  27. 27

    Bostwick DG, Waters DJ, Farley ER, Meiers I, Rukstalis D, Cavanaugh WA et al. Group consensus reports from the Consensus Conference on Focal Treatment of Prostatic Carcinoma, Celebration, Florida, February 24, 2006. Urology 2007; 70: 42–44.

    Article  PubMed  Google Scholar 

  28. 28

    Haffner MC, Mosbruger T, Esopi DM, Fedor H, Heaphy CM, Walker DA et al. Tracking the clonal origin of lethal prostate cancer. J Clin Invest 2013; 123: 4918–4922.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  29. 29

    de la Rosette J, Ahmed H, Barentsz J, Johansen TB, Brausi M, Emberton M et al. Focal therapy in prostate cancer-report from a consensus panel. J Endourol 2010; 24: 775–780.

    CAS  Article  PubMed  Google Scholar 

  30. 30

    Aoun F, Limani K, Peltier A, Marcelis Q, Zanaty M, Chamoun A et al. High intensity focused ultrasound versus brachytherapy for the treatment of localized prostate cancer: a matched-pair analysis. Adv Urol 2015; 2015: 350324.

    Article  PubMed  PubMed Central  Google Scholar 

  31. 31

    Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG et al. Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study. Eur Urol 2015; 68: 927–936.

    Article  PubMed  Google Scholar 

  32. 32

    Elterman DS, Barkin J, Radomski SB, Fleshner NE, Liu B, Bensimon K et al. Results of high intensity focused ultrasound treatment of prostate cancer: early Canadian experience at a single center. Can J Urol 2011; 18: 6037–6042.

    PubMed  Google Scholar 

  33. 33

    Limani K, Aoun F, Holz S, Paesmans M, Peltier A, van Velthoven R . Single high intensity focused ultrasound session as a whole gland primary treatment for clinically localized prostate cancer: 10-year outcomes. Prostate Cancer 2014; 2014: 186782.

    Article  PubMed  PubMed Central  Google Scholar 

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Correspondence to F Aoun.

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van Velthoven, R., Aoun, F., Marcelis, Q. et al. A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer. Prostate Cancer Prostatic Dis 19, 79–83 (2016). https://doi.org/10.1038/pcan.2015.55

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