MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the safety and feasibility of Magnetic
      Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages
      40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an
      identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of <
      15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.
    

Detailed description: 
      This is a single center, single arm, open-label study to evaluate the safety and feasibility
      of MRI guided focal prostate cancer laser ablation in patients with a focus of prostate
      cancer who has not yet received treatment for their cancer. Patients fulfilling the inclusion
      criteria and having none of the clinical exclusion criteria will be enrolled into the study
      after they (or their legal representative) have signed the informed consent form. No control
      group will be utilized and all patients will receive MRI guided FLA for their focal prostate
      cancer. As part of the screening process, patients will provide a medical history and undergo
      a physical examination, including a digital rectal examination (DRE). At the first visit,
      patients will also be given a copy of the informed consent, and a copy of quality of life and
      performance questionnaires to assess urinary, rectal, and erectile functions (IPSS
      questionnaire for urinary, IIEF5 questionnaire for erectile function, for all). MR imaging at
      visit 2 will serve to determine if a single site of prostate cancer can be localized. At
      visit 3, 12 cores transrectal us guided prostate biopsy will confirm yet again that this is a
      unilateral, unifocal histologically proven tumour in the site recognized on the MRI. On
      preoperative examination (visit 4) - blood and urine samples will be taken prior to
      procedure. Visit 5 - the focal treatment will be performed under regional or general
      anesthesia, or conscious sedation, (as determined by the anesthesiologist) in the TGH
      research 1.5T MRI suite. MR guided FLA procedure is similar to MR guided brachytherapy, with
      fibers and probes inserted transperineally outside the bore of the MR and then the patient is
      moved inside the bore to verify position before deploying the laser. The treatment is
      expected to last 2-3 hours, and patients expected to have no pain during the whole procedure.
      Laser ablation will be monitored using MR thermometry14, 15.An MRI scan will be done
      immediately after the ablation, as initial assessment for ensuring complete treatment of the
      target volume, as well as ensuring that treatment does not extend to critical structures.

      The size and location of the lesion will be compared to the planned target volume and the
      proximity of the lesion to the urethra and rectum. If the lesion does not encompass the
      target volume, and is still a safe distance from either critical structure, FLA may be
      continued.

      On day 3, 7, 30, and 120 following the procedure, patients will be assessed for clinical
      signs of urinary, rectal, and erectile complications and will complete validated
      self-assessment tools on these functions. Free/Total PSA will be monitor on visit -1 and
      after the treatment on day 7, 30 and 120, in order to try to understand the effect of FLA on
      PSA. Four months after the focal procedure, a further 12 cores biopsy, plus 2 cores aimed to
      the ablated lesion will then be preformed to verify the oncological effectiveness of the
      treatment.
    

Intervention name(s): MRI Targeted Focal Laser Thermal Therapy
Intervention type(s): Procedure
Intervention description(s): A 980nm wavelength diode laser will be fired for up to 30 minutes. Temperature probes will be inserted to ensure that the local temperature does not exceed 55 degrees Celsius for more than 5 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment