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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Procedure: Focal Phothtermal Ablation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Focal Phothtermal Ablation<br>* Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of MR/US Fusion and MR Targeting |  | 7 Days after Focal Therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Neoplasm, Localized, Photothermal, Radical Prostatectomy