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.

Brief Title

MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer

Official Title

Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer

Brief Summary

The primary objective of this study is to evaluate the safety and feasibility of Magnetic<br /> Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages<br /> 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an<br /> identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of <<br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.