MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Study Overview
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Brief Summary
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Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

Detailed Description
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CLINICAL TRIAL OF OBSERVATION NATURE PRIMARY OUTCOME Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival SECONDARY OUTCOMES Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care DATA COLLECTION Complete H&P, family history, past medical and surgical history, social history, allergies, and medications As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI. Procedure specific Co-Registration quality with ultrasound denoting quality Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment Uroflow and PVR measurements by 3 to 6 month of treatment MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan SAFETY MEASURES Periodic evaluation of registry to ensure consistency in follow up Patient remainders of tests required

Official Title
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Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Conditions
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Neoplasms Prostate, Cancer of the Prostate

Intervention / Treatment
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* Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe Absence of extra-capsular extension Absence of seminal vesicle invasion Absence of regional or distant metastatic disease Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy Treated with Cryotherapy of the prostate Treatment based on co-registration between MP-MRI and Prostate Ultrasound Exclusion Criteria: Prior treatment of prostate cancer in the form of surgery. Performance status greater than 0 based on ECOG criteria Mental status impairment

Ages Eligible for Study
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Minimum Age: 55 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

| Intervention/Treatment |
| --- |
|Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY|Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic cryoprobes/devices are employed to freeze and all circuled or noted cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological Control | Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological Control | Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy | 1 Year | 
| Oncological Control | Lack of prostate cancer presence in gland measured by MP-MRI | Yearly, up to 10 years | 
| Urinary Functional Outcomes | Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals | Every 3 months up to 24 months | 
| Perioperative Outcomes | Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel | 30 days | 
| Sexual Functional Outcomes | Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires | Every 3 months up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryotherapy, Outcomes, Prostate, PSA, FUSION, Ultrasound, MRI, Cancer, Recurrence, QOL, Quality of Life, Urinary function, Sexual Function