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

Phase 1

Completed

• Conditions: Prostate Neoplasm
• Interventions: Procedure: Focal Phothtermal Ablation

• Registration Number: NCT00805883
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Study Start: 2009-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2011-05-26
• Last Update Posted: 2011-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Focal Phothtermal Ablation	-

Primary Outcome Measures

Name	Time	Method
Validity of MR/US Fusion and MR Targeting	7 Days after Focal Therapy

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada