Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer

Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from injury, which may improve the outcome of genitourinary function. This study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.

Sex

Male

Minimum age

18 Years

Maximum age

95 Years

Inclusion Criteria:

* Language spoken: Finnish, English or Swedish
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
* Biopsy-confirmed acinar adenocarcinoma of the prostate
* Gleason score ≥ 3+4/International Society of Urological Pathology grade group ≥ 2
* High volume Gleason score 6 as determined on biopsies (\>2 positive cancer core or ≥ 50% cancer in a core)
* Patient presenting low volume Gleason score 6 disease and refuses active surveillance
* Non-metastatic disease; high-risk patients according to European Association of Urology risk group stratification will undergo F-Prostate specific membrane antigen-Positron Emission Tomography/Computer Tomography to exclude distant metastasis
* Lesion visible on MRI (Prostate Imaging Reporting and Data System v2 4-5)
* Eligible for general anesthesia (American Society of Anesthesiologists (ASA)≤ 3)

Exclusion Criteria:

* Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)

  * Acute unresolved urinary tract infection
  * Claustrophobia
  * Hip replacement surgery or other metal in the pelvic area
  * Known allergy to gadolinium
  * Inability to insert urinary catheter
  * Suspected tumor on baseline MRI further than 30 mm or within 3 mm of the prostatic urethra
  * Prostate calcifications or cysts obstructing planned ultrasound beam path within the targeted tissue volume
  * Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist

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