Localised Prostate CancerMILANCT07412275
Microwave Intervention Under Local Anesthesia
A study testing Local Anesthesia (lidocaine hydrochloride) in people with Localised Prostate Cancer, run by Koelis at 2 sites in 2 countries.
Trial summary
This study aims to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localised Prostate Cancer
- What is being tested?
- Local Anesthesia (lidocaine hydrochloride)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jun 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old
- Patient undergoing Koelis TMA® intervention
- Patient is suitable for general, local anesthesia as well as sedation
- No psychiatric illness that would prevent informed consent or optimal treatment and follow-up
- Free, informed and written consent, dated and signed by the patient and the investigator, no later than the day of inclusion and before any examination required by the study.
- Patient affiliated to a social security scheme or beneficiary of such a scheme in accordance with the regulations in force.
Who cannot join
- Severe illness within the last 6 months before the screening visit, including any of the following: uncontrolled congestive heart failure, uncontrolled angina pectoris, myocardial infarction, stroke.
- Ineligibility for a Koelis TMA® intervention
- Contraindication to general anesthesia and deep sedation.
- Uncontrolled coagulopathies or bleeding disorder
- A person already participating in an interventional clinical study.
- A person placed under judicial protection, guardianship, or legal supervision and incapable of freely giving informed consent.
- Patient detained in an institution by medical or judicial decision.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site
Institut Jules Bordet
Brussels, 1070
PELTIER Alexandre, MD, PHD, +32 (0) 2 541 31 71, alexandre.peltier@hubruxelles.be
PELTIER Alexandre, MD, PHD
France1 site
Hôpital Cochin Port Royal
Paris, 75014
ANRACT Julien, MD, +33 (0) 158413355, julien.anract@aphp.fr
ANRACT Julien, MD
About this study
Official title: Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer
This study aims to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer.
Eligible patients will undergo the procedure under local anesthesia instead of general anesthesia or deep sedation as part of their routine clinical care.
Read more
The primary objective is to assess the feasibility of completing the procedure under local anesthesia, defined by the proportion of patients in whom the procedure is successfully completed under local anesthesia. Secondary objectives include the assessment of safety, ease of performance, patient satisfaction, and the use of analgesic medication.
This study is designed as a feasibility clinical investigation conducted in a routine clinical practice setting.
Read the detailed description
This clinical investigation is a prospective feasibility study designed to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer. Koelis TMA® is a CE-marked medical device use without any modification to the device's intended use.
The study will be conducted in a routine clinical care setting. Eligible patients requiring the procedure will be included after providing informed consent.
The study consists of four visits. At the inclusion visit (Visit 0), patient eligibility will be confirmed and baseline data will be collected. The intervention will be performed during Visit 1 under local anesthesia according to standard clinical practice. A follow-up phone call (Visit 2) will be conducted 7 days after the procedure (±2 days) to assess safety and tolerability data. The end-of-study visit (Visit 3) will take place 1 month after the intervention (±7 days) during a routine follow-up consultation.
The primary objective of the study is to assess the feasibility of performing the procedure under local anesthesia. Feasibility will be evaluated by the proportion of patients in whom the procedure is successfully completed under local anesthesia. If the patient presents marked discomfort, pain, or any other symptoms that make the continuation of the procedure inappropriate, it may be interrupted at his request or at the initiative of the investigator. Local anesthesia can therefore be converted to general anesthesia or deep sedation to allow treatment to continue.
Secondary objectives include the assessment of procedure tolerability, safety, ease of performance as assessed by the operator, patient satisfaction related to anesthesia, and the amount of analgesic or pain medication administered during the study period.
- Conditions
- Localised Prostate Cancer
- Being tested
- Local Anesthesia (lidocaine hydrochloride)
- Keywords
- Localised prostate cancer, TMA, Local anesthesia, Koelis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia (lidocaine hydrochloride)Procedure or surgery
Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthesia | Experimental | Patient undergoing the focal targeted microwave ablation procedure performed under local anesthesia using the Koelis TMA® Receives: Procedure: Local Anesthesia (lidocaine hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer
Feasibility will be assessed by the rate of complete procedure performed under local anesthesia, defined as the proportion of patients in whom the procedure is completed under local anesthesia without the unplanned use of general anesthesia or sedation or premature termination of treatment
Measured: Day 0 - Intervention
Secondary outcomes (11)
Immediate Patient satisfaction regarding the procedure under local anesthesia
The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire after the procedure
Measured: Day 0 - Intervention
1 month patient satisfaction regarding the procedure under local anesthesia
The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire 1 month after the procedure
Measured: 1 month
Ease of performing the procedure from the operator's point of view
The ease of performing the procedure will be evaluated by a score given by the operator (1: very easy; 2: easy; 3: moderate; 4: difficult, 5: very difficult).
Measured: Day 0 - Intervention
Patient's level of pain at the time of administration of local anesthesia
The patient's average pain level will be assessed during the administration of local anesthesia by a numerical pain rating scale from 0 to 10.
Measured: Day 0 - Intervention
Patient's pain level during the TMA treatment,
The patient's average pain level will be assessed during microwave ablation via a numerical pain rating scale from 0 to 10.
Measured: Day 0 - Intervention
To assess the patient's level of pain after treatment,
The patient's average pain level will be assessed 1 hour after treatment via a numerical pain rating scale from 0 to 10.
Measured: Day 0 - Intervention
To evaluate the duration of the different stages of the procedure,
Description of the duration of the different stages of the ablation procedure will be evaluated by:
- The duration of the local anesthesia (minutes)
- Microwave ablation treatment duration (minutes)
- The duration of the intervention (minutes) (start-end of the procedure)
- The time spent by the patient in the hospital post-procedure (hours)
Measured: Day 0 - Intervention
Success of the completion of the procedure
The success of the completion/procedure will be assessed by the percentage of recovery of the lesion to be treated by microwave ablations
Measured: Day 0 - Intervention
Feasibility of performing a TMA procedure in ambulatory setting
The feasibility of ambulatory treatment will be assessed based on the percentage of hospitalizations lasting less than 12 hours.
Measured: Day 0 - Intervention
Tolerance of performing the procedure under local anesthesia,
Safety will be assessed by the number and severity of procedure-related adverse events, collected throughout the duration of the study
Measured: 1 month
Amount of medication received by the patient
The amount of medication received as measured by the amount of analgesic/painkiller received by the patient throughout the duration of the study
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localised Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is exploratory in nature. Given its feasibility design, no formal sample size calculation has been performed, and a total of 20 patients are planned to be included.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koelis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ANRACT Julien, MD, Principal investigator, APHP - Hôpital Cochin Port Royal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412275
- Sponsor's protocol ID
- MILA
- Other IDs
- 2026-A00095-46
- Acronym
- MILA
- Status last verified
- May 2026
- First submitted
- 9 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07412275
- Acronym / sponsor ID
- MILA / MILA
- Conditions
- Localised Prostate Cancer
- Keywords
- Localised prostate cancer, TMA, Local anesthesia, Koelis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KoelisIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer.
Eligible patients will undergo the procedure under local anesthesia instead of general anesthesia or deep sedation as part of their routine clinical care.
The primary objective is to assess the feasibility of completing the procedure under local anesthesia, defined by the proportion of patients in whom the procedure is successfully completed under local anesthesia. Secondary objectives include the assessment of safety, ease of performance, patient satisfaction, and the use of analgesic medication.
This study is designed as a feasibility clinical investigation conducted in a routine clinical practice setting.
Detailed description
This clinical investigation is a prospective feasibility study designed to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer. Koelis TMA® is a CE-marked medical device use without any modification to the device's intended use.
The study will be conducted in a routine clinical care setting. Eligible patients requiring the procedure will be included after providing informed consent.
The study consists of four visits. At the inclusion visit (Visit 0), patient eligibility will be confirmed and baseline data will be collected. The intervention will be performed during Visit 1 under local anesthesia according to standard clinical practice. A follow-up phone call (Visit 2) will be conducted 7 days after the procedure (±2 days) to assess safety and tolerability data. The end-of-study visit (Visit 3) will take place 1 month after the intervention (±7 days) during a routine follow-up consultation.
The primary objective of the study is to assess the feasibility of performing the procedure under local anesthesia. Feasibility will be evaluated by the proportion of patients in whom the procedure is successfully completed under local anesthesia. If the patient presents marked discomfort, pain, or any other symptoms that make the continuation of the procedure inappropriate, it may be interrupted at his request or at the initiative of the investigator. Local anesthesia can therefore be converted to general anesthesia or deep sedation to allow treatment to continue.
Secondary objectives include the assessment of procedure tolerability, safety, ease of performance as assessed by the operator, patient satisfaction related to anesthesia, and the amount of analgesic or pain medication administered during the study period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is exploratory in nature. Given its feasibility design, no formal sample size calculation has been performed, and a total of 20 patients are planned to be included.
| Arm | Type | Receives |
|---|---|---|
| Local Anesthesia | Experimental | Procedure: Local Anesthesia (lidocaine hydrochloride)Patient undergoing the focal targeted microwave ablation procedure performed under local anesthesia using the Koelis TMA® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years old
- Patient undergoing Koelis TMA® intervention
- Patient is suitable for general, local anesthesia as well as sedation
- No psychiatric illness that would prevent informed consent or optimal treatment and follow-up
- Free, informed and written consent, dated and signed by the patient and the investigator, no later than the day of inclusion and before any examination required by the study.
Key exclusion criteria (7 listed)
- Severe illness within the last 6 months before the screening visit, including any of the following: uncontrolled congestive heart failure, uncontrolled angina pectoris, myocardial infarction, stroke.
- Ineligibility for a Koelis TMA® intervention
- Contraindication to general anesthesia and deep sedation.
- Uncontrolled coagulopathies or bleeding disorder
- A person already participating in an interventional clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Anesthesia (lidocaine hydrochloride)Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia | Procedure or surgery | Local Anesthesia |
Primary outcome
Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer
Time frame: Day 0 - Intervention
Feasibility will be assessed by the rate of complete procedure performed under local anesthesia, defined as the proportion of patients in whom the procedure is completed under local anesthesia without the unplanned use of general anesthesia or sedation or premature termination of treatment
11 secondary outcomes
Immediate Patient satisfaction regarding the procedure under local anesthesia
Time frame: Day 0 - Intervention
1 month patient satisfaction regarding the procedure under local anesthesia
Time frame: 1 month
Ease of performing the procedure from the operator's point of view
Time frame: Day 0 - Intervention
Patient's level of pain at the time of administration of local anesthesia
Time frame: Day 0 - Intervention
Patient's pain level during the TMA treatment,
Time frame: Day 0 - Intervention
To assess the patient's level of pain after treatment,
Time frame: Day 0 - Intervention
To evaluate the duration of the different stages of the procedure,
Time frame: Day 0 - Intervention
Success of the completion of the procedure
Time frame: Day 0 - Intervention
Feasibility of performing a TMA procedure in ambulatory setting
Time frame: Day 0 - Intervention
Tolerance of performing the procedure under local anesthesia,
Time frame: 1 month
Amount of medication received by the patient
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANRACT Julien, MD principal investigator
APHP - Hôpital Cochin Port Royal
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia (lidocaine hydrochloride) in people with Localised Prostate Cancer, run by Koelis at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JOSSAN Claire (+33 (0)7 85 05 40 23, claire.jossan@koelis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer (time frame: Day 0 - Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.