Clinical trial NCT03531099: Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
Official title: Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
HIFU focal
adverse effect
low risk
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 108
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.

The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.


Eligibility criteria: Inclusion Criteria:

* Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
* Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score \> 14.
* Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:

  * Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:

    * If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
    * If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
  * A maximum tumor length\> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
  * Gleason 6 score (risk group 1 of the D'Amico classification).
  * Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
* PSA ≤ 15ng / ml.
* Patient affiliated with health insurance or beneficiary of an equivalent plan.

Exclusion Criteria:

* Contraindications to treatment with HIFU-F:

  * Tumor not accessible.
  * Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
  * History of pelvic irradiation
  * Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
  * Fistula of the urinary tract or rectum.
  * Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
  * Anatomical abnormality of the rectum or rectal mucosa.
  * Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
  * History of intestinal inflammatory pathology.
  * Uro-genital infection in progress (the infection to be treated before HIFU treatment).
  * Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
  * Allergy to latex.
  * Thickness of the rectal wall\> 10mm.
* TURP indication. Bladder neck incision is allowed .
* Patient with a medical contraindication to Sonovue® injection.
* Patient with a medical contraindication on MRI.
* Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
* History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
* History of sclerosis of the bladder neck or urethral stenosis.
* Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
* Patients with unstable neurological pathology.
* Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
* Legal person protected by law.
* Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

Primary outcomes:
measure: patient proportion who needed to seek radical treatment
timeFrame: 48 month
Secondary outcomes:
measure: proportion of patients needing additional treatment
timeFrame: 24 months
measure: proportion of patients needing additional treatment
timeFrame: 48 months
measure: rate of positive biopsies
timeFrame: 24 months
measure: rate of positive biopsies
timeFrame: 48 months
measure: clinically significant cancer rate
timeFrame: 24 months
measure: clinically significant cancer rate
timeFrame: 48 months
measure: Gleason score
timeFrame: 24 months
measure: Gleason score
timeFrame: 48 months
measure: Appearance of another cancerous focus in the other half of the prostate
timeFrame: 24 months
measure: Appearance of another cancerous focus in the other half of the prostate
timeFrame: 48 months
measure: Appearance of metastases
timeFrame: 24 months
measure: Appearance of metastases
timeFrame: 48 months
measure: Appearance of an extra capsular extension
timeFrame: 24 months
measure: Appearance of an extra capsular extension
timeFrame: 48 months
measure: Overall survival
timeFrame: 48 months
measure: Prostate cancer specific survival
timeFrame: 48 months
measure: Recurrence free survival
timeFrame: 48 months
measure: Proportion of serious adverse effect
timeFrame: 48 months
measure: Quality of life score
timeFrame: over the 48 months
measure: EPIC-26 score
timeFrame: over the 48 months
measure: IPSS score
timeFrame: over the 48 months
measure: IIEF-5 score
timeFrame: over the 48 months
measure: STAi-YB score
timeFrame: Over the 48 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Polyclinique du parc Rambot
city: Besançon
country: France
facility: Clinique Saint-Vincent
city: Bordeaux
country: France
facility: Service d'Urologie, Clinique Tivoli Ducos
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - CHU
city: Colmar
country: France
facility: Service d'Urologie, CHU de Guebwiller Colmar
city: Lille
country: France
facility: Service d'Urologie CHRU de Lille, Hôpital HURIEZ
city: Lille
country: France
facility: Service d'Urologie Générale de Santé - Hôpital Privé La Louvière
city: Lyon
country: France
facility: Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,
city: Marseille
country: France
facility: Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord
city: Paris
country: France
facility: Département d'Urologie, Institut Montsouris
city: Pierre-bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Herblain
country: France
facility: Clinique Urologique Nantes Atlantis
city: Suresnes
country: France
facility: Service d'Urologie, Hôpital Foch
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital de Rangueil
Study officials:
References: