MRI-guided Focal Laser Ablation

Study Overview
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Brief Summary
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Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

Official Title
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Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Focal laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); Maximum MRI visible lesion size is ≤ 15 mm large axis; Life expectancy at inclusion of more 10 years; Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies; Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen < 15 ng/ml); Patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice. Exclusion criteria: History of prostate surgery; History of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; History of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); Severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18; Tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles; Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI; Impossibility to obtain a valid informed consent; Patients unable to undergo MR imaging, including those with contra-indications; Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging; Patients with evidence for nodal or metastatic disease; Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low or intermediate grade prostate cancer<br> | Procedure: Focal laser ablation<br>* Focal laser ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine incontinence incontinence | To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3). | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local cancer control | To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies. | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | 
| International Prostate Symptom Score (IPSS) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | 
| Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | 
| International Consultation on Incontinence Questionnaire (ICIQ) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ). | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | 
| Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25 | To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25). | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | 
| Complication rate | To evaluate the complication rate related to the technique | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focal laser ablation