MRI/Ultrasound Fusion Guided Prostate Cryotherapy

  • Recruiting
  • Observational
  • Procedure
  • Urological Research Network, LLC
  • 55 Years -


Study Purpose

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.

Intervention

Procedure : FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY


Eligibility Requirements

info icon 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

info icon Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe

info icon Absence of extra-capsular extension

info icon Absence of seminal vesicle invasion

info icon Absence of regional or distant metastatic disease

info icon Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy

info icon Treated with Cryotherapy of the prostate

info icon Treatment based on co-registration between MP-MRI and Prostate Ultrasound

info icon Prior treatment of prostate cancer in the form of surgery.

info icon Performance status greater than 0 based on ECOG criteria

info icon Mental status impairment

Recruiting status

Recruiting

Estimated enrollment

5000

 
Study start date

Aug 31, 2013

Study end date

Aug 31, 2033

Last updated

Mar 23, 2025

Primary purpose

N/A

Design

Observational

Intervention

Procedure

Study phase

N/A

Allocation

N/A

 

Sponsor:

Urological Research Network, LLC

Collaborator:

N/A

Investigator:

FERNANDO J BIANCO, MD

EUSEBIO LUNA, MD

Isabel H Lopez, MD

NCT02381990

Clinic Location Investigator Distance RECRUITING STATUS Contact