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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00805883
First received: December 8, 2008
Last updated: May 26, 2011
Last verified: December 2008
  Purpose

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 Intervention Phase
Prostate Neoplasm
Procedure: Focal Phothtermal Ablation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Validity of MR/US Fusion and MR Targeting [ Time Frame: 7 Days after Focal Therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805883

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Trachtenberg, M.D University Health Network, Toronto
  More Information

Additional Information:
No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. John Trachtenberg, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00805883     History of Changes
Other Study ID Numbers: FLTT 001
Study First Received: December 8, 2008
Last Updated: May 26, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Prostate Neoplasm
Localized
Photothermal
Radical Prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014