Overview
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Eligibility
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.