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MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805883
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : May 27, 2011
Information provided by:
University Health Network, Toronto

Brief Summary:
This is a clinical research study designed to measure the effectiveness of focal Interstitial Laser Thermal Therapy (ILTT) at killing prostate tumours. Patients with "low risk" prostate cancer (Trans Rectal US Guided Biopsy positive) will undergo an MRI scan to try to localize the tumour. If the MRI detects the tumour they will then undergo a perineal ablative procedure (ILTT) under general anaesthetic. Seven days following ILTT they will come back to the hospital for a Radical Retoropubic Prostatectomy (RRP) procedure, which is the removal of a prostate gland through a surgical incision. After removal, the prostate will undergo further analysis to determine the exact location of cancer and evaluate the extent of cancer death caused by ILTT.

Condition or disease Intervention/treatment Phase
Prostate Neoplasm Procedure: Focal Phothtermal Ablation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
Study Start Date : February 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1 Procedure: Focal Phothtermal Ablation
Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.

Primary Outcome Measures :
  1. Validity of MR/US Fusion and MR Targeting [ Time Frame: 7 Days after Focal Therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men 40-80 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 biopsy;
  • A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
  • Prostate specific antigen (PSA) level 15 ng/mL

Exclusion Criteria:

  • Medically unfit for Radical Retropubic Prostectomy (RRP) surgery
  • Patients who are unwilling or unable to give informed consent;
  • Patients with foci location in the apex of the prostate or isolated transition zone cancers
  • 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 recommendations;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805883

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: John Trachtenberg, M.D University Health Network, Toronto
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. John Trachtenberg, University Health Network, Toronto Identifier: NCT00805883    
Other Study ID Numbers: FLTT 001
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: December 2008
Keywords provided by University Health Network, Toronto:
Prostate Neoplasm
Radical Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases