MR Image Guided Therapy in Prostate Cancer
Condition: Prostate Cancer; Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Visualase Thermal Therapy System
Intervention description: Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Toxicity; Thermal Ablation/Damage; Localized Prostate Cancer; Laser Ablation; PSA Levels; Prostate Cancer

Summary:

      Background:

      - One way to treat prostate cancer is to use a laser to direct extreme heat to a small area
      of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors
      want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI
      will be used to help locate tumor cells and guide the laser during surgery. However,
      MRI-guided laser therapy has not been used to treat many people with prostate cancer. More
      studies are needed to see whether it can destroy tumor cells permanently.

      Objectives:

      - To test the safety and effectiveness of treating prostate tumors with laser therapy guided
      by magnetic resonance imaging.

      Eligibility:

      - Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has
      not spread to other parts of the body.

      Design:

        -  Participants will be screened with a physical exam and medical history. They will also
           have blood tests and imaging studies, and will complete questionnaires about their
           health.

        -  Participants will have the MRI-guided laser treatment in the hospital. The doctor will
           use the MRI to control how much energy is delivered by the laser and how much tissue is
           destroyed. The entire procedure usually takes from 1.5 to 3 hours.

        -  After the treatment, participants will have a catheter put in to keep the bladder
           emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and
           bladder spasms will be given. Participants will leave the hospital once they are well
           enough to go home.

        -  Participants will have follow-up visits 3, 6, 9, 12, 18, 24, and 36 months after the
           therapy. They will have physical exams, and blood and urine tests. They will also answer
           questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the
           therapy. They will have a prostate biopsy to see if there is any tumor every 12 months
           for the first 2 years. Another biopsy may be done in the third year.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Men greater than 18 years of age

          -  Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on
             magnetic resonance (MR) imaging

          -  Prostate cancer is diagnosed by transrectal ultrasound guided standard 12 core biopsy
             or MR image guided biopsies

               -  Gleason Score less than or equal to 7 (3+4), less than or equal to 3 cores
                  positive in a standard 12 core biopsy or less than or equal to 4 cores positive
                  on MR image guided biopsy where in 2 cores are taken from each of the two
                  magnetic resonance imaging (MRI) target lesions

               -  If the standard biopsy cores are positive, they must be from the same location in
                  the prostate as MR Lesion was biopsied and proven to be cancer. (Left / Right,
                  Base, Mid Gland, Apex).

          -  MRI obtained within 6 months of ablation

          -  Metastatic Disease work up as per National Comprehensive Cancer Network (NCCN)
             guidelines (www.nccn.org). Bone scan indicated to r/o metastatic disease if [clinical
             T1 and prostate-specific antigen (PSA) > 20 or T2 and PSA > 10]

          -  PSA less than or equal to 15 ng/ml or PSA density less than or equal to 0.15 ng/ml(2)
             in patients with a PSA > 15 ng/ml

          -  The patient has given written informed consent after the nature of the study and
             alternative treatment options have been explained.

          -  Patients who present with local recurrence or residual tumor after prostate cancer
             treatment which is visible on MRI.

        EXCLUSION CRITERIA:

          -  The presence of 3 or more MR Visible lesions positive on biopsy

          -  The presence of extra capsular, seminal vesical invasion or metastatic disease.

          -  Patient is unable to tolerate MRI (foreign body, i.e. pacemaker or other implanted
             device; claustrophobia; inability to tolerate rectal coil; etc.)

          -  Patient with inability to follow up

          -  Acute urinary tract infection

          -  Lower urinary tract symptoms defined by a International Prostate symptom score (IPSS)
             >20

          -  Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30
             are excluded, due to they will not be able to undergo gadolinium enhance MRI.

          -  Patients with Uncontrolled Coagulopathies who are at increased risk of bleeding.

          -  Altered mental status preventing consent or answering questions during conduct of the
             trial will be excluded for safety purposes.

          -  Other serious illnesses according to the Principal Investigator (PI): involving the
             cardiac, respiratory, central nervous system (CNS), renal or hepatic organ systems,
             which would preclude study completion or impede the determination of causality of any
             complications experienced during the conduct of this study.

          -  A Standard 12 core biopsy positive for cancer with no corresponding MR targeted lesion
             positive for cancer in the same general region of the prostate (Right Apex, Right Mid
             Gland, Right Base, Left Base, Left Mid Gland, Left Apex)