MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Description

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.

Conditions

Neoplasms Prostate, Cancer of the Prostate

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Study Overview

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Study Details

Study overview

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.

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Condition
Neoplasms Prostate
Intervention / Treatment

-

Contacts and Locations

Miami Lakes

Urological Research Network, Miami Lakes, Florida, United States, 33016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Urological Research Network, LLC,

FERNANDO J BIANCO, MD, PRINCIPAL_INVESTIGATOR, UROLOGICAL RESEARCH NETWORK

EUSEBIO LUNA, MD, STUDY_DIRECTOR, UROLOGICAL RESEARCH NETWORK

Isabel H Lopez, MD, STUDY_DIRECTOR, UROLOGICAL RESEARCH NETWORK

Study Record Dates

2033-08