Clinical trial NCT04307056: Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
Official title: EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Ultrasound Therapy
Keywords: HIFU
Lead sponsor: Association Francaise d'Urologie
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 3862
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the efficacy of HIFU treatment with standard treatment in two situations:

1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.


Eligibility criteria: General inclusion criteria

* Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
* classified as low or intermediate risk
* Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\].
* Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
* Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml
* Patient affiliated with health insurance or beneficiary of an equivalent plan

Inclusion criteria for the HIFU Arm

* Patients 70 years of age or older
* Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years

Inclusion Criteria for Total Prostatectomy Arm

• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.

NON-INCLUSION CRITERIA

* Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
* Included patient simultaneously participating in another research study

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 30 months
Secondary outcomes:
measure: Immediate or late complications
timeFrame: 6 weeks after treatment
measure: Immediate or late complications
timeFrame: Day 0, Inclusion
measure: immediate or late complications
timeFrame: 3 months after treatment
measure: immediate or late complications
timeFrame: 6 months after treatment
measure: immediate or late complications
timeFrame: 12 months after treatment
measure: immediate or late complications
timeFrame: 18 months after treatment
measure: immediate or late complications
timeFrame: 24 months after treatment
measure: immediate or late complications
timeFrame: 30 months after treatment
measure: urinary function
timeFrame: Day 0, Inclusion
measure: urinary function
timeFrame: 6 months after treatment
measure: urinary function
timeFrame: 12 months after treatment
measure: urinary function
timeFrame: 24 months after treatment
measure: urinary function
timeFrame: 30 months after treatment
measure: urinary function
timeFrame: Day 0, Inclusion
measure: urinary function
timeFrame: 6 months after treatment
measure: urinary function
timeFrame: 12 months after treatment
measure: urinary function
timeFrame: 18 months after treatment
measure: urinary function
timeFrame: 24 months after treatment
measure: urinary function
timeFrame: 30 months after treatment
measure: urinary function
timeFrame: Day 0, Inclusion
measure: urinary function
timeFrame: 6 months after treatment
measure: urinary function
timeFrame: 12 months after treatment
measure: urinary function
timeFrame: 18 months after treatment
measure: urinary function
timeFrame: 24 months after treatment
measure: urinary function
timeFrame: 30 months after treatment
measure: sexual fonction
timeFrame: Day 0, Inclusion
measure: sexual fonction
timeFrame: 6 months after treatment
measure: sexual fonction
timeFrame: 12 months after treatment
measure: sexual fonction
timeFrame: 24 months after treatment
measure: sexual fonction
timeFrame: 30 months after treatment
measure: Evaluation of quality of life
timeFrame: Day 0, Inclusion
measure: Evaluation of quality of life
timeFrame: 6 months after treatment
measure: Evaluation of quality of life
timeFrame: 12 months after treatment
measure: Evaluation of quality of life
timeFrame: 18 months after treatment
measure: Evaluation of quality of life
timeFrame: 24 months after treatment
measure: Evaluation of quality of life
timeFrame: 30 months after treatment
measure: Evaluation of quality of life
timeFrame: Day 0, Inclusion
measure: Evaluation of quality of life
timeFrame: 6 months after treatment
measure: Evaluation of quality of life
timeFrame: 12 months after treatment
measure: Evaluation of quality of life
timeFrame: 18 months after treatment
measure: Evaluation of quality of life
timeFrame: 24 months after treatment
measure: Evaluation of quality of life
timeFrame: 30 months after treatment
measure: Evaluation of quality of life
timeFrame: Day 0, Inclusion
measure: Evaluation of quality of life
timeFrame: 6 months after treatment
measure: Evaluation of quality of life
timeFrame: 12 months after treatment
measure: Evaluation of quality of life
timeFrame: 18 months after treatment
measure: Evaluation of quality of life
timeFrame: 24 months after treatment
measure: Evaluation of quality of life
timeFrame: 30 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 6 weeks after treatment
measure: The rate of patients in biochemical failure
timeFrame: 3 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 6 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 12 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 18 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 24 months after treatment
measure: The rate of patients in biochemical failure
timeFrame: 30 months after treatment
measure: The rate of local recurrence
timeFrame: 3 months after treatment
measure: Survival without metastases
timeFrame: 6 months after treatment
measure: Survival without metastases
timeFrame: 12 months after treatment
measure: Survival without metastases
timeFrame: 18 months after treatment
measure: Survival without metastases
timeFrame: 24 months after treatment
measure: Survival without metastases
timeFrame: 30 months after treatment
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier d'Aix en Provence
city: Arnas
country: France
facility: Polyckinique du Beaujolais
city: Bayonne
country: France
facility: Clinique St Etienne
city: Besançon
country: France
facility: CHRU de Besançon
city: Besançon
country: France
facility: Clinique St Vincent
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Bordeaux
country: France
facility: Clinique St Augustin
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: Nouvelle clinique Bel Air
city: Chambray-lès-Tours
country: France
facility: Pôle Santé Léonard de Vinci
city: Chambéry
country: France
facility: CHR de Chambéry
city: Clermont-Ferrand
country: France
facility: PôleSanté République
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Dijon
country: France
facility: Polyclinique du parc Drevon
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Guilherand-Granges
country: France
facility: Hôpital Privé Drome Ardèche
city: Le Mans
country: France
facility: Cliique du Pré
city: Le Puy-en-Velay
country: France
facility: Clinique Bon Secours
city: Lille
country: France
facility: CHRU de Lille
city: Lille
country: France
facility: Clinique La Louvière
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices Civils de lyon
city: Marseille
country: France
facility: Hôpital St Joseph
city: Marseille
country: France
facility: AP-AM
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Mulhouse
country: France
facility: Clinique Diaconat-Roosevelt
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Fondation St Jean de Dieu - Clinique Oudinot
city: Paris
country: France
facility: Clinique Turin
city: Paris
country: France
facility: Hôpital St Joseph
city: Paris
country: France
facility: Hôpital TENON
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Europeen Georges Pompidou
city: Pontoise
country: France
facility: CH de pontoise
city: Reims
country: France
facility: Clinique Courlancy
city: Rennes
country: France
facility: CHU de rennes
city: Saint-Herblain
country: France
facility: Clinique Nantes Atlantis
city: Saintes
country: France
facility: CH de Saintonge
city: Strasbourg
country: France
facility: Clinique Rhéna
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: Clinique St Michel
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Clinique St Jean du Languedoc
city: Vannes
country: France
facility: Clinique Océanne
city: Écully
country: France
facility: Cliniqe du Val d'Ouest
city: pointe-à-Pitre
country: Guadeloupe
facility: CHU de guadeloupe
Study officials:
References: