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

Prostate Cancer Clinical Trial

— VIOLETTE  

Official title:

Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582656
• Other study ID #: VIOLETTE
• Secondary ID: 2019-A00803-54
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: May 2023

Study information

• Verified date: August 2021
• Source: Koelis
• Contact: Damien FONTANELLI, MSc
• Phone: +33 4 58 17 68 10
• Email: fontanelli[@]koelis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	American Hospital of Paris	Neuilly-sur-Seine
France	Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)	Paris
France	Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)	Paris
France	Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis	Saint-Herblain
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Koelis

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with no evidence of cancer on targeted biopsy	The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer	12 months
Secondary	Proportion of radical salvage treatment	Proportion of patients undergoing radical salvage treatment of the index lesion	12 months
Secondary	Time to radical salvage treatment	Time to radical salvage treatment of the index lesion	12 months
Secondary	Proportion of patients with any cancer in the untreated area	Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy	12 months
Secondary	Proportion of patients undergoing treatment for cancer in the untreated area	Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment	12 months
Secondary	IPSS questionnaire	Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS score compared to baseline, score ranging from 0 to 35 (the higher the worse)	7 days and 1, 6 and 12 months
Secondary	IIEF-5 questionnaire	Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF-5 score compared to baseline, score ranging from 5 to 25 (the lower the worse)	7 days and 1, 6 and 12 months
Secondary	MSHQ-EjD-SF questionnaire	Changes in patients' reported outcome measures (PROMs) for ejaculatory function and bother using MSHQ-EjD-SF score compared to baseline, score ranging from 1 to 15 (the lower the worse) for ejaculatory function and from 0 to 5 for bother/satisfaction (the higher the worse)	7 days and 1, 6 and 12 months
Secondary	Urine flow	Change in urine flow, using a uroflowmeter compared to baseline	7 days and 1, 6 and 12 months
Secondary	Adverse events	Number and severity of device and procedure related adverse events	12 months
Secondary	Patient post-operative pain level	Average patient post-operative pain level reported on a pain numeric rating scale, with a range from 0 (no pain) to 10 (worst pain ever)	Treatment day-evaluated between 2 and 4 hours after the procedure
Secondary	Patient satisfaction	Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)	1, 6 and 12 months
Secondary	Ease of the procedure	Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)	Day 1
Secondary	Duration of the procedure and associated variables	Duration of the procedure and associated variables	Day 1
Secondary	PSA	Change in PSA measurement compared to baseline	1, 3, 6, 9 and 12 months
Secondary	PSA Nadir	Time to PSA Nadir after treatment of the index lesion	12 months
Secondary	Prostate volume	Change in volume of the prostate on the mpMRI compared to baseline	7 days and 6 and 12 months
Secondary	Patient motivation	Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)	Baseline