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  • Cancer de la Prostate
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Traitement par ultrasons focalisés du cancer localisé de la prostate: Résultats carcinologiques et pronostic sexuel

High intensity focused ultrasound for the treatment of localized prostate cancer: efficacy and impact on sexual function

Andrologie volume 13, pages 242–251 (2003)Cite this article

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Objectifs

Evaluer l’efficacité du traitement du cancer localisé de la prostate par ultrasons focalisés de haute intensité (HIFU), et son retentissement sur la fonction sexuelle.

Matériels et méthodes

120 patients potentiellement curables présentant un cancer de la prostate de stade clinique T1–T2 avec un PSA initial <10 ng/ml (groupe 1) et 167 patients avec un PSA initial <30 ng/ml (groupe 2), non candidats à la prostatectomie radicale, ont été traités par HIFU (ABLA-THERM®, EDAP SA). Dans ces 2 populations, l’échec clinique a été défini comme la nécessité de recourir à un traitement adjuvant. La progression de la maladie (échec biologique) a été strictement définie par l’identification d’un cancer résiduel sur les biopsies de contrôle (quelque soit le taux de PSA) ou par 3 élévations successives du PSA (lorsque les biopsies de contrôle étaient négatives) avec une vélocité supérieure à 0,75 ng/ml/an. Les taux de survie sans progression ont été calculés selon la méthode de Kaplan-Meier. Les taux de succès stratifiés selon les facteurs de risque ont été comparés par Log-Rank tests. L’impact du traitement sur la fonction sexuelle a été évalué au moyen d’un questionnaire chez 70 patients ayant reçu un traitement standard et 28 patients pour lesquels le traitement tentait de préserver les nerfs érecteurs.

Résultats

Le suivi moyen est de 27 mois et 23 mois dans les groupes 1 et 2, respectivement. Les biopsies de contrôle ne montrent pas de cancer résiduel chez 103 patients du groupe 1 (86%), et 131 patients du groupe 2 (78%). Dans le groupe 1, un cancer résiduel a été identifié chez 17 patients mais seuls 6 patients ont nécessité un traitement adjuvant (hormonal: n=2, radiothérapie: n=4), soit un taux de succès clinique de 95%. Dans le groupe 2, 36 patients ont présenté des biopsies positives lors du suivi, dont 21 ayant nécessité un traitement adjuvant (hormonal: n=10, radiothérapie: n=11), soit un taux de succès clinique de 87,5%. Le taux de survie sans progression est de 76,9% et 66% dans les groupes 1 et 2, respectivement. Dans le groupe 2, les taux de survie sans progression ont été stratifiés en fonction du niveau de risque initial: 85% pour les patients à faible risque, 67,5% pour les patients à risque intermédiaire, et 42% pour les patients à haut risque. Dans la population globale, 70 patients avaient une fonction sexuelle normale avant traitement: 25 patients (36%) ont conservé des érections autorisant les rapports sexuels après le traitement par ultrasons. Une procédure de traitement visant à épargner les nerfs érecteurs a été testée sur 28 patients: 43% de ces patients ont conservé des érections permettant la pénétration vaginale, montrant ainsi que cette procédure est encore perfectible.

Conclusion

Ces résultats montrent que le traitement par ultrasons focalisés est une option thérapeutique dont les résultats carcinologiques sont comparables aux autres traitements non chirurgicaux du cancer de la prostate. Après traitement complet de la glande prostatique, plus d’un tiers des patients conservent une érection permettant la pénétration vaginale, ce résultat étant à interpréter pour une population âgée de 72 ans en moyenne. La mise au point d’une procédure permettant d’épargner les nerfs érecteurs est en cours.

Abstract

Introduction

Since 1999, a therapeutic device using High Intensity Focused Ultrasound (HIFU) technology has been marketed in Europe for the treatment of localized prostate cancer. Clinical and technical development was designed to provide a minimally invasive alternative for these patients. The purpose of this study was to evaluate the efficacy of HIFU therapy for localized prostate cancer and its impact on sexual function.

Material and Methods

HIFU technology is based on a convergent beam of high intensity ultrasound that creates a sudden and sharp increase in temperature (85°C to 100°C) in the tissues at the focal point. This leads to a precise lesion in the tissue, adjustable from 19 to 24 mm in height and 2 mm in diameter. Successive displacements of the focal point are computer-driven, allowing treatment of a defined volume. All patients were treated with the ABLATHERM® device (EDAP SA, France); they were treated using the device prototypes between 1993 to 1999 and then with the marketed machine. The treatment procedure was improved from 2000 onwards with the combination of transurethral resection of the prostate (TURP) in order to reduce post-treatment catheter time. A nerve-sparing procedure was also tested in 2002.

The selected population included 120 patients considered to be potentially curable with clinical stage T1–T2 prostate cancer and an initial PSA < 10 ng/ml (group 1). A larger group of 167 patients with an initial PSA < 30 ng/ml was also considered (group 2). All patients were not candidates for surgery due to their age or comorbidities. In the two groups, clinical failure was defined by the need for administration of an adjuvant prostate cancer treatment (hormone deprivation or external radiation). Disease progression, or biochemical failure, was strictly defined as any evidence of residual cancer on follow-up biopsies (regardless of the PSA level), or 3 successive increases of the PSA level (with negative follow-up biopsies), with a velocity > 0.75 ng/ml/year. Disease-free survival rates were calculated using the Kaplan-Meier method. Survival rates were compared using the log-rank test. The impact of HIFU treatment on sexual function was assessed by a questionnaire in 70 patients who underwent standard HIFU treatment and in 28 patients in whom a nerve-sparing procedure was performed.

Results

Patient baseline characteristics (± SD) were, in group 1 and group 2 respectively: mean age: 71.2 (± 5.34) years and 71.8 (± 5.11) years; clinical stage: T1 for 61 patients and T2 for 59 patients in group 1, and T1 for 77 patients, T2 for 85 patients and T3 for 5 patients in group 2; mean initial PSA level: 5.67 (± 2.47) ng/ml and 9.30 (± 6.01) ng/ml; Gleason score: 2–6 for 77 patients and 7–10 for 43 patients in group 1, and 2–6 for 98 patients, 7 for 44 patients, and 8–10 for 25 patients in group 2; mean prostate volume: 33.6 (± 16.5) ml and 34.4 (± 16.7) ml, respectively. Mean follow-up was 27 months (range: 3–96 months) in group 1, and 23 months (range: 3–90 months) in group 2. In group 1, a residual cancer was diagnosed in 17 patients, but only 6 patients needed adjuvant treatment due to a significant rise of the PSA level (hormone deprivation: n=2, external radiation: n=4), leading to a clinical success rate of 95%. Similarly, in group 2, 36 patients presented with positive follow-up biopsies, and 21 of them required adjuvant treatment (hormone deprivation: n=10, external radiation: n=11), leading to a clinical success rate of 87.5%. The disease-free survival rates (previously defined on the combined biopsy and PSA criteria) were 76.9% and 66% in group 1 and 2, respectively. In addition, the disease-free survival rate in group 2 was stratified according to the initial prognosis risk level: 85% in low-risk patients (i.e. patients with clinical stage T1–T2a and PSA < 10 ng/ml and Gleason score < 7), 67.5% in intermediate-risk patients (i.e. clinical stage T2b or PSA 10–20 ng/ml or Gleason score = 7), and 42% in high-risk patients (i.e. clinical stage T2c or PSA > 20 ng/ml or Gleason score > 7). In the overall population, 70 patients had normal sexual function prior to HIFU treatment; 25 patients (36%) still had erections allowing sexual intercourse with penetration after treatment. A nerve-sparing procedure was also performed in 28 potent patients: 43% of these patients had persistent erections allowing sexual intercourse with penetration after treatment, indicating that this nerve-sparing procedure still needs to be improved.

Conclusion

The efficacy results observed after HIFU treatment are similar to those observed after other non-surgical treatments for prostate cancer. After complete HIFU treatment of the gland, more than 1/3 of patients still reported erections allowing sexual intercourse with penetration; these results must be interpreted for an elderly population (mean age: 72 years). A nerve-sparing procedure is currently being perfected and tested.

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Authors and Affiliations

  1. Urologie et Chirurgie de la transplantation, Hôpital Edouard Herriot, 69437, Lyon

    Albert Gelet, Laura Poissonnier, Raymonde Bouvier, Olivier Rouviere, Denis Lyonnet & Jean Michel Dubernard

  2. Unité INSERM 556, Lyon

    Jean -Yves Chapelon

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  1. Albert Gelet
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  2. Laura Poissonnier
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  3. Jean -Yves Chapelon
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Correspondence to Albert Gelet.

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Gelet, A., Poissonnier, L., Chapelon, J.Y. et al. Traitement par ultrasons focalisés du cancer localisé de la prostate: Résultats carcinologiques et pronostic sexuel. Androl. 13, 242–251 (2003). https://doi.org/10.1007/BF03034878

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Basic and Clinical Andrology

ISSN: 2051-4190