RecruitingNCT02381990

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Sponsor

Urological Research Network, LLC

Enrollment

5,000 participants

Start Date

Aug 1, 2013

Study Type

OBSERVATIONAL

Conditions

Cancer of the Prostate Neoplasms, Prostate

Summary

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.

Eligibility

Sex: MALEMin Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well a targeted freezing treatment (called cryotherapy) works for men with low- or intermediate-risk prostate cancer, when guided by a combination of MRI and ultrasound imaging to precisely target the tumor. **You may be eligible if...** - You are a man diagnosed with low- or intermediate-risk prostate cancer - If you are between 55 and 65 years old, less than half of your sampled prostate tissue is cancerous - If you are older than 65, the same sample limit applies - The cancer has not spread outside the prostate or to nearby structures - You had a specialized MRI of the prostate before your biopsy or more than 10 weeks after it - You are being treated with prostate cryotherapy guided by MRI-ultrasound fusion imaging **You may NOT be eligible if...** - You have already had surgery for prostate cancer - You have significant health limitations affecting daily functioning - You have significant memory or thinking problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFUSE 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