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MRI/Ultrasound Fusion Guided Prostate Cryotherapy
RECRUITINGSponsored by Urological Research Network, LLC
Actively Recruiting
SponsorUrological Research Network, LLC
Started2013-08
Est. completion2023-08
Eligibility
Age55 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT02381990
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
Age: 55 Years+Sex: MALEHealthy volunteers accepted
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
Conditions3
CancerCancer of the ProstateNeoplasms Prostate
Locations1 site
Urological Research Network
Miami Lakes, Florida, 33016
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Actively Recruiting
SponsorUrological Research Network, LLC
Started2013-08
Est. completion2023-08
Eligibility
Age55 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT02381990