Clinical trial NCT03568188: Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer
Official title: Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
HIFU focal
adverse effect
intermediate risk
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 170
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (\>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study


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 a G8 score \> 14.
* Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:

  * A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
  * Gleason score= 7 (3+4).
  * Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
* 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 pelvic radiotherapy.
* 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).
* 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 with controlled disease (Control of the pathology)
timeFrame: 12 months
Secondary outcomes:
measure: proportion of patients needing additional treatment
timeFrame: 12 months
measure: proportion of patients needing additional treatment
timeFrame: 48 months
measure: proportion of patients needing additional radical treatment
timeFrame: 12 months
measure: proportion of patients needing additional radical treatment
timeFrame: 48 months
measure: rate of positive biopsies
timeFrame: 12 months
measure: rate of positive biopsies
timeFrame: 24 months
measure: rate of positive biopsies
timeFrame: 48 months
measure: clinically significant cancer rate
timeFrame: 48 months
measure: Gleason score
timeFrame: 12 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: 12 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: 12 months
measure: Appearance of metastases
timeFrame: 24 months
measure: Appearance of metastases
timeFrame: 48 months
measure: Appearance of an extra capsular extension
timeFrame: 12 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: patient proportion with controlled disease (Control of the pathology)
timeFrame: 48 months
measure: Ancillary study: Measure of anti-tumoral immunity induction
timeFrame: over the 48 months
measure: Ancillary study: Measure of Circulating Tumor Cells (CTC) number reduction
timeFrame: over the 48 months
measure: Ancillary study: Measure of ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level reduction.
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: Hôpital L. Pasteur, Hôpitaux Civils de 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 - Hospices Civils de Lyon
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
city: Geneva
country: Sweden
facility: Clinique Générale Beaulieu - Swiss International Prostate Center
Study officials:
References: