Localised Prostate Cancer
Conditions
Keywords
Localised prostate cancer, TMA, Local anesthesia, Koelis
Brief 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. 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.
Interventions
Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia
Sponsors
Koelis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Patient satisfaction regarding the procedure under local anesthesia | Day 0 - Intervention | The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire after the procedure |
| 1 month patient satisfaction regarding the procedure under local anesthesia | 1 month | The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire 1 month after the procedure |
| Ease of performing the procedure from the operator's point of view | Day 0 - Intervention | 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). |
| Patient's level of pain at the time of administration of local anesthesia | Day 0 - Intervention | 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. |
| Patient's pain level during the TMA treatment, | Day 0 - Intervention | The patient's average pain level will be assessed during microwave ablation via a numerical pain rating scale from 0 to 10. |
| To assess the patient's level of pain after treatment, | Day 0 - Intervention | The patient's average pain level will be assessed 1 hour after treatment via a numerical pain rating scale from 0 to 10. |
| To evaluate the duration of the different stages of the procedure, | Day 0 - Intervention | Description of the duration of the different stages of the ablation procedure will be evaluated by: 1. The duration of the local anesthesia (minutes) 2. Microwave ablation treatment duration (minutes) 3. The duration of the intervention (minutes) (start-end of the procedure) 4. The time spent by the patient in the hospital post-procedure (hours) |
| Success of the completion of the procedure | Day 0 - Intervention | The success of the completion/procedure will be assessed by the percentage of recovery of the lesion to be treated by microwave ablations |
| Feasibility of performing a TMA procedure in ambulatory setting | Day 0 - Intervention | The feasibility of ambulatory treatment will be assessed based on the percentage of hospitalizations lasting less than 12 hours. |
| Tolerance of performing the procedure under local anesthesia, | 1 month | Safety will be assessed by the number and severity of procedure-related adverse events, collected throughout the duration of the study |
| Amount of medication received by the patient | 1 month | The amount of medication received as measured by the amount of analgesic/painkiller received by the patient throughout the duration of the study |
Countries
Belgium, France
Contacts
CONTACTJOSSAN Claire
CONTACTJOFFRAY Eloïse
PRINCIPAL_INVESTIGATORANRACT Julien, MD
APHP - Hôpital Cochin Port Royal
Outcome results
None listed