Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

NCT ID: NCT04582656

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2023-05-31

Brief Summary

Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

Detailed Description

European and American guidelines recommend several therapeutic alternatives: radical surgical treatment, external beam radiotherapy or brachytherapy. However, whole-gland treatment induces significant morbidity and burden on quality of life. Targeted treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.

The purpose of this study is to assess the efficacy of a novel ablation treatment using microwaves, delivered transrectally or transperineally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using Organ Based Tracking (OBT) fusion with the TRINITY system (KOELIS, Meylan, France). The same system will be used to identify the index lesion and guide the targeted microwave ablation performed with the TATO3 device (Biomedical Srl, Florence, Italy).

All patients will undergo biopsy at 12 months of follow-up. A biopsy session will also be performed at 6 months, but only for patients with imaging results suspicious for cancer within the ablated area on the mpMRI.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Targeted microwave ablation

Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion

Group Type: EXPERIMENTAL

Targeted microwave ablation

Intervention Type: DEVICE

Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Interventions

Targeted microwave ablation

Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient aged from 45 to 76 years old
• Life expectancy >10 years at the inclusion time
• Patient diagnosed with an intermediate-risk prostate cancer, defined by:

• A T1c or T2a clinical stage
• A unique cancer focus of Gleason (3+4) (Grade Group 2)
• A PSA level <20 ng/mL
• Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion
• Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (no more than 3 months before inclusion)
• Patient suitable for IV sedation or general anesthesia and focal microwave ablation
• No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
• Known coagulopathy or bleeding disorders are controlled
• Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial
• Patient affiliated to social security regimen or beneficiary of such regimen for local regions

Exclusion Criteria

• Past medical history of prostate surgery
• Past medical history of radiotherapy or pelvic trauma
• Past medical history of acute prostatitis
• Presently taking hormonal manipulation or androgen supplements.
• Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin
• Severe BPH-related urinary tract symptoms, defined by an IPSS score >18
• Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
• Contraindications for MRI exam
• Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI
• Presence of two or more clinically significant cancer foci in the inclusion biopsy exam
• Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
• Tumor largest axis >12 mm on the prostate MRI
• Distance between the cancer focus and the apex <10 mm on the prostate MRI
• Distance between the cancer focus and the rectum <5 mm on the prostate MRI
• Patient already participating in an interventional clinical trial
• Patient protected by law

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Koelis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland VAN VELTHOVEN, MD

Role: STUDY_CHAIR

Uro Science & Consulting

Locations

Institut Jules Bordet

Brussels, , Belgium

Site Status: RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

American Hospital of Paris

Neuilly-sur-Seine, , France

Site Status: RECRUITING

Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)

Paris, , France

Site Status: RECRUITING

Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

Paris, , France

Site Status: RECRUITING

Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis

Saint-Herblain, , France

Site Status: RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status: RECRUITING

Countries

Belgium; France

Central Contacts

Damien FONTANELLI, MSc

Role: CONTACT

fontanelli@koelis.com

+33 4 58 17 68 10

Facility Contacts

Alexandre PELTIER, MD

Role: primary

alexandre.peltier@bordet.be

+32 (0) 2 541 31 71

Franck BLADOU, MD

Role: primary

franck.bladou@chu-bordeaux.fr

+ 33 (0) 5 57 82 28 00

Aurel MESSAS, MD

Role: primary

aurel.messas@ahparis.org

+33 (0) 1 46 41 25 25

Pierre MOZER, MD

Role: primary

pierre.mozer@psl.aphp.fr

+33 (0) 1 42 17 71 50

Nicolas BARRY DELONGCHAMPS, MD

Role: primary

nicolas.barry-delongchamps@aphp.fr

+33 (0) 1 58 41 27 52

Eric POTIRON, MD

Role: primary

ep@cliniqueuro.com

+33 (0) 2 28 03 06 09

Bernard MALAVAUD, MD

Role: primary

malavaud.bernard@iuct-oncopole.fr

+33 (0) 5 31 15 60 16

Other Identifiers

2019-A00803-54

Identifier Type: OTHER

Identifier Source: secondary_id

VIOLETTE

Identifier Type: -

Identifier Source: org_study_id