Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

NCT03568188 | Completed Phase 2

• 2 other identifiers: 69HCL18_02922018-A01171-54
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 14

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

Conditions

Prostate Cancer

Keywords

prostate cancer; HIFU focal; adverse effect; intermediate risk

Outcome Measures

Primary Outcomes (1)

• patient proportion with controlled disease (Control of the pathology)

  The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.

  12 months

Secondary Outcomes (32)

• proportion of patients needing additional treatment

  12 months

• proportion of patients needing additional treatment

  48 months

• proportion of patients needing additional radical treatment

  12 months

• proportion of patients needing additional radical treatment

  48 months

• rate of positive biopsies

  12 months

Study Arms (1)

HIFU treatment

EXPERIMENTAL

170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.

Procedure: treatment with focal HIFU; Biological: PSA dosage; Device: MRI; Other: Questionnaires; Procedure: Prostatic biopsies; Biological: blood test; Biological: urine test

Interventions

PSA dosage BIOLOGICAL

PSA dosage will be regularly performed during patient follow up thanks to blood sampling.

HIFU treatment

MRI DEVICE

MRI exam will be regularly performed during patient follow up.

HIFU treatment

Questionnaires OTHER

Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function).

HIFU treatment

Prostatic biopsies PROCEDURE

Prostatic biopsies will be regularly performed during patient follow up.

HIFU treatment

blood test BIOLOGICAL

if the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) will be performed during their follow up.

HIFU treatment

urine test BIOLOGICAL

if the patient decides to participate in the ancillary study, a urine test (for PCA3 test) will be performed during their follow up.

HIFU treatment

treatment with focal HIFU PROCEDURE

HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.

HIFU treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (14)

Polyclinique du parc Rambot

Aix-en-Provence, 13100, France

Location

Clinique Saint-Vincent

Besançon, 25044, France

Location

Service d'Urologie, Clinique Tivoli Ducos

Bordeaux, 33000, France

Location

Groupe Hospitalier Pellegrin - CHU

Bordeaux, 33076, France

Location

Hôpital L. Pasteur, Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Service d'Urologie CHRU de Lille, Hôpital HURIEZ

Lille, 59000, France

Location

Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

Lille, 59000, France

Location

Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

Lyon, 69437, France

Location

Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

Marseille, 13915, France

Location

Département d'Urologie, Institut Montsouris

Paris, 75014, France

Location

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Clinique Urologique Nantes Atlantis

Saint-Herblain, 44800, France

Location

Service d'Urologie, Hôpital Foch

Suresnes, 92150, France

Location

CHU de Toulouse - Hôpital de Rangueil

Toulouse, 31400, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutics; Surveys and Questionnaires; Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 26, 2018
• Study Start: September 28, 2018
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (14)