MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Recruiting now

Conditions studied: Neoplasms Prostate, Cancer of the Prostate

In brief

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.

Key facts

Study ID

NCT02381990

Run by

Urological Research Network, LLC

People needed

5000

Starts

2013-08-01

Expected to finish

2033-08-01

Last updated by the study team

2023-01-26

Who can join

Age: 55 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior treatment of prostate cancer in the form of surgery.
• Performance status greater than 0 based on ECOG criteria
• Mental status impairment

Where it is running

• Urological Research Network — Miami Lakes, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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