AI-Powered Research

1. MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging)
2. maximum MRI visible lesion size is <<= 15 mm large axis
3. 45 to 76 years old patient
4. life expectancy at the inclusion of more 10 years
5. underwent systematic TRUS-guided biopsy
6. diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore
MRI guided biopsies
7. criteria of low and intermediate risk of progression and eligibility for focal therapy
a. a clinical stage of maximum T2c
b. a maximum biopsy Gleason score of 4 + 3 on targeted biopsies
c. a serum prostate specific antigen < 15 ng/ml
8. 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

1. history of prostate surgery
2. history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis
3. history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer)
4. severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an
IPSS score > 18
5. tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles
6. maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic
biopsies outside the visible tumor area on mpMRI
7. Impossibility to obtain a valid informed consent
8. Patients unable to undergo MR imaging, including those with contra-indications
9. Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or
abdomino perineal resection)
10. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and
compromises the quality of MR imaging
11. Patients with evidence for nodal or metastatic disease
12. Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The oncologic safety (PSA measurements at 6 weeks, 3, 6, 12 and 24 months; MR<br /><br>imaging at 6, 12 and 24 months; and*targeted and random systematic 12-core<br /><br>biopsy at 12 months post focal therapy), functional outcome, complication rates<br /><br>(i.e. urinary incontinence, irritative/obstructive bowel and erectile<br /><br>dysfunction), re-treatment percentage, the EORTC QLQ-PR25 scale for sexual<br /><br>symptoms, ICIQ (incontinence), IPSS (urinary problems) and SHIM IIEF-5<br /><br>(erectile dysfunctioning), success rate, complication rates (according to<br /><br>Clavien system for surgical complications), operating time and hospital stay.</p><br>

Secondary Outcome Measures