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

KOELIS

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: Targeted microwave ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04582656

2019-A00803-54 (Other Identifier)

VIOLETTE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: Male

Ages: 45 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Targeted microwave ablation

Experimental group

Description:

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

Treatment:

Device: Targeted microwave ablation