Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Urological Research Network, LLC
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.
Description
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 Functio…
Eligibility
- Age range
- 55+ years
- Sex
- Male
- Healthy volunteers
- No
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 * Trea…
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
Location
- Urological Research NetworkMiami Lakes, Florida