Magnetic resonance imaging-guided focal laser ablation of prostate cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted
imaging); • maximum MRI visible lesion size is <= 20 mm large axis; • age 45 to
76 years old; • life expectancy at inclusion of more 10 years; • diagnosis of
prostate cancer confirmed by targeted biopsy; • criteria of low and
intermediate risk of progression and eligibility for focal therapy; o clinical
stage of maximum T2c o maximum biopsy Gleason score of 4 + 3 on targeted
biopsies o 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 extra-capsular extension or
invasion of the seminal vesicles; • patients with >2 lesions; • 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>• Technical success, as determined by:<br /><br>o Completion of the laser ablation without technical failures<br /><br>o Achievement of complete ablation shown by MRI after treatment calculated<br /><br>using image co-registration software.<br /><br>• Total procedure time<br /><br>• Total number of fiber positions and ablations needed<br /><br>• Procedure-related adverse events and complications following SIR criteria</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Tumor response measured with MRI 6 months after treatment (Lack of<br /><br>enhancement on dynamic contrast enhanced MR imaging in the treated area)<br /><br>• Progression free survival at 6 months<br /><br>• Functional outcome (i.e. urinary incontinence, and erectile dysfunction). The<br /><br>IPSS and IIEF-5 (erectile dysfunctioning) at 6 weeks, 3, 6 and 12 months.<br /><br>• Complication rates according to SIR system<br /><br>• Local progression free survival</p><br>