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

Phase 1/Phase 2
45 Years
80 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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 (IPPSS questionnaire for urinary, IIEF5 questionnaire for erectile function,
Porpus 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 1-2 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

On day 1, 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, MRI will be done to assess the ablated lesion, a
further 12 cores biopsy, plus 2 cores aimed to the ablated lesion will then be preformed
providing MRI excludes rectal abnormalities, to verify the oncological effectiveness of the

Inclusion Criteria:

- Men 45-80 years of age;

- Histologically proven prostate carcinoma;

- Prostate cancer clinical stage T1c and T2a

- Prostate MRI must confirm area suspicious for cancer in the sector of the positive

- Prostate specific antigen (PSA) level less than 15 ng/mL

- 12 cores biopsy, with histologically proven prostate carcinoma, in the suspicious
region on MRI.

- PORPUS, IPSS, and IIEF complete prior to procedure

- Life expectancy of greater than 5 years, based on co-morbidity not related to
prostate cancer.

Exclusion Criteria:

- Medically unfit for focal therapy of the prostate

- Patients who are unwilling or unable to give informed consent;

- Patients who have received androgen suppression therapy

- Patients who have received or are receiving chemotherapy for prostate carcinoma;

- Patients previously treated with surgery to the prostate (traditional, endoscopic or
minimally invasive including HIFU, TUNA, RITA, microwave, TURP, cryotherapy or any
curative treatment

- Patients who have undergone radiation therapy for prostate cancer or to the pelvis

- Any condition, or history of illness or surgery that, in the opinion of the
Investigator, might confound the results of the study or pose additional risks to the
patient (e.g. significant cardiovascular conditions or allergies);

- Patients with a history of non compliance with medical therapy and/or medical

- Patients who are unwilling or unable to complete the patient self-assessment

- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter
abnormalities, or any other symptom that prevents normal micturition.

- Patients who have participated in a clinical study and/or received treatment with an
investigational treatment and/or product within the past 90 days;

- If the patient is unable to undergo regional anesthesia

- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe
claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

- Any condition, or history of illness that, in the opinion of the investigator will
confound or increase the patient risk during the study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Transrectal Ultrasound Guided Prostate Biopsy

Outcome Description:

Four months after the focal procedure, MRI will be done to assess the ablated lesion. Provided MRI excludes rectal abnormalities, a 12 core biopsy, plus 2 cores aimed at the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.

Outcome Time Frame:

4 Months Post Treatment

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

November 2009

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms