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

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805883
• Other study ID #: FLTT 001
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2008
• Last updated: May 26, 2011
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2008
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of MR/US Fusion and MR Targeting		7 Days after Focal Therapy	No

External Links

•   Trial Results