Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer


Condition: Localized Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03814252

Sponsor: Turku University Hospital

Eligibility:

  • Age: minimum 18 Years maximum 95 Years
  • Gender: Male

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

View trial on ClinicalTrials.gov


email news signup