Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

Study Overview
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Brief Summary
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The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.

Detailed Description
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Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data. The following information will be collected for all patients: Demographic data: date of birth, age, gender, ethnicity, Height, weight. Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests. For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected: MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values. Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable). For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected: Procedure details. Evaluation of success: results of following PSA test, MRI and/or prostate biopsy. Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.

Official Title
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Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center Age 18-90. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI-US Fusion<br>patients undergoing MRI targeted prostate biopsy | |
| Focal<br>patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy) | PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years | 5 years | 
| Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy. | clinically significant prostate cancer is defined as Gleason 7 and above | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner | IPSS questioner is a validated tool to assess urinary symptoms. Total score is ranged 0-35. Lower values represent a better outcome. IPSS will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure | 5 years | 
| Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner | IIEF-5 questioner is a validated tool to assess erectile function in men. Total score is ranged 1-25. Higher values represent a better outcome. IIEF-5 will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI-targeted prostate biopsy, focal treatment