- 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
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
Prior treatment of prostate cancer in the form of surgery.
Performance status greater than 0 based on ECOG criteria
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
Publications
Websites
N/A
NCT02381990
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