Back to resultsEfficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer (VIOLETTE)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Targeted microwave ablation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Cancer, Prostate, Targeted treatment, Microwave
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
Sites / Locations
- Institut Jules BordetRecruiting
- Centre Hospitalier Universitaire de BordeauxRecruiting
- American Hospital of ParisRecruiting
- Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)Recruiting
- Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)Recruiting
- Urologie Nantes Clinique & Institut d'Urologie - Site AtlantisRecruiting
- Institut Claudius RegaudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted microwave ablation
Arm Description
Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of radical salvage treatment
Proportion of patients undergoing radical salvage treatment of the index lesion
Time to radical salvage treatment
Time to radical salvage treatment of the index lesion
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
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
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)
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)
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)
Urine flow
Change in urine flow, using a uroflowmeter compared to baseline
Adverse events
Number and severity of device and procedure related adverse events
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)
Patient satisfaction
Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)
Ease of the procedure
Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)
Duration of the procedure and associated variables
Duration of the procedure and associated variables
PSA
Change in PSA measurement compared to baseline
PSA Nadir
Time to PSA Nadir after treatment of the index lesion
Prostate volume
Change in volume of the prostate on the mpMRI compared to baseline
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04582656
Brief Title
Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koelis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Cancer, Prostate, Targeted treatment, Microwave
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, single-arm, open-label, 12-month follow-up clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Targeted microwave ablation
Arm Type
Experimental
Arm Description
Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion
Intervention Type
Device
Intervention Name(s)
Targeted microwave ablation
Intervention Description
Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach
Primary Outcome Measure Information:
Title
The proportion of patients with no evidence of cancer on targeted biopsy
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of radical salvage treatment
Description
Proportion of patients undergoing radical salvage treatment of the index lesion
Time Frame
12 months
Title
Time to radical salvage treatment
Description
Time to radical salvage treatment of the index lesion
Time Frame
12 months
Title
Proportion of patients with any cancer in the untreated area
Description
Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy
Time Frame
12 months
Title
Proportion of patients undergoing treatment for cancer in the untreated area
Description
Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment
Time Frame
12 months
Title
IPSS questionnaire
Description
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)
Time Frame
7 days and 1, 6 and 12 months
Title
IIEF-5 questionnaire
Description
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)
Time Frame
7 days and 1, 6 and 12 months
Title
MSHQ-EjD-SF questionnaire
Description
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)
Time Frame
7 days and 1, 6 and 12 months
Title
Urine flow
Description
Change in urine flow, using a uroflowmeter compared to baseline
Time Frame
7 days and 1, 6 and 12 months
Title
Adverse events
Description
Number and severity of device and procedure related adverse events
Time Frame
12 months
Title
Patient post-operative pain level
Description
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)
Time Frame
Treatment day-evaluated between 2 and 4 hours after the procedure
Title
Patient satisfaction
Description
Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)
Time Frame
1, 6 and 12 months
Title
Ease of the procedure
Description
Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)
Time Frame
Day 1
Title
Duration of the procedure and associated variables
Description
Duration of the procedure and associated variables
Time Frame
Day 1
Title
PSA
Description
Change in PSA measurement compared to baseline
Time Frame
1, 3, 6, 9 and 12 months
Title
PSA Nadir
Description
Time to PSA Nadir after treatment of the index lesion
Time Frame
12 months
Title
Prostate volume
Description
Change in volume of the prostate on the mpMRI compared to baseline
Time Frame
7 days and 6 and 12 months
Title
Patient motivation
Description
Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)
Time Frame
Baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien FONTANELLI, MSc
Phone
+33 4 58 17 68 10
Email
fontanelli@koelis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland VAN VELTHOVEN, MD
Organizational Affiliation
Uro Science & Consulting
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre PELTIER, MD
Phone
+32 (0) 2 541 31 71
Email
alexandre.peltier@bordet.be
First Name & Middle Initial & Last Name & Degree
Alexandre PELTIER, MD
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck BLADOU, MD
Phone
+ 33 (0) 5 57 82 28 00
Email
franck.bladou@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Franck BLADOU, MD
Facility Name
American Hospital of Paris
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurel MESSAS, MD
Phone
+33 (0) 1 46 41 25 25
Email
aurel.messas@ahparis.org
First Name & Middle Initial & Last Name & Degree
Aurel MESSAS, MD
Facility Name
Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MOZER, MD
Phone
+33 (0) 1 42 17 71 50
Email
pierre.mozer@psl.aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre MOZER, MD
Facility Name
Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas BARRY DELONGCHAMPS, MD
Phone
+33 (0) 1 58 41 27 52
Email
nicolas.barry-delongchamps@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nicolas BARRY DELONGCHAMPS, MD
Facility Name
Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric POTIRON, MD
Phone
+33 (0) 2 28 03 06 09
Email
ep@cliniqueuro.com
First Name & Middle Initial & Last Name & Degree
Eric POTIRON, MD
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard MALAVAUD, MD
Phone
+33 (0) 5 31 15 60 16
Email
malavaud.bernard@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Bernard MALAVAUD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
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