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

This study is currently recruiting participants.

Verified by University Health Network, Toronto, December 2008

First Received: December 8, 2008 Last Updated: January 4, 2010 History of Changes

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00805883

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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

Contacts

Contact: Uri Lindner, M.D

416-946-4501 ext 5361

uri.lindner@uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Uri Lindner, M.D 416-946-4501 ext 5361 uri.lindner@uhn.on.ca
Sub-Investigator: Uri Lindner, M.D

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

John Trachtenberg, M.D

University Health Network, Toronto

More Information

No publications provided

Responsible Party:	University Health Network, Toronto ( Dr. John Trachtenberg )
Study ID Numbers:	FLTT 001
Study First Received:	December 8, 2008
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00805883 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Prostate Neoplasm
Localized
Photothermal
Radical Prostatectomy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010