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

Tracking Information

First Received Date ^ICMJE

December 8, 2008

Last Updated Date

December 9, 2008

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00805883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Neoplasm

Intervention ^ICMJE

Procedure: Focal Phothtermal Ablation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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;

Gender

Male

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Uri Lindner, M.D

416-946-4501 ext 5361

uri.lindner@uhn.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00805883

Responsible Party

Dr. John Trachtenberg, University Health Network, Toronto

Study ID Numbers ^ICMJE

FLTT 001

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John Trachtenberg, M.D

University Health Network, Toronto

Information Provided By

University Health Network, Toronto

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP