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RECRUITING
NCT02381990

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Sponsor: Urological Research Network, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

55 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2013-08

Completion Date

2033-08

Last Updated

2023-01-26

Healthy Volunteers

No

Interventions

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

Locations (1)

Urological Research Network

Miami Lakes, Florida, United States