RECRUITING

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

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Conditions

Neoplasms ProstateCancer of the ProstateProstatePSAFUSIONUltrasoundMRICancerCryotherapyOutcomesRecurrenceQOL, Quality of LifeUrinary functionSexual Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Quick Facts

Study Start:2013-08
Study Completion:2033-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02381990

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe
  3. * Absence of extra-capsular extension
  4. * Absence of seminal vesicle invasion
  5. * Absence of regional or distant metastatic disease
  6. * Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy
  7. * Treated with Cryotherapy of the prostate
  8. * Treatment based on co-registration between MP-MRI and Prostate Ultrasound
  1. * Prior treatment of prostate cancer in the form of surgery.
  2. * Performance status greater than 0 based on ECOG criteria
  3. * Mental status impairment

Contacts and Locations

Study Contact

CIELO D GUERRA, BS
CONTACT
305-515-9887
CIELO@BESTUROLOGY.NET
LUANDA SIANO, PA
CONTACT
305-822-7227
LUANDA@BESTUROLOGY.NET

Principal Investigator

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 Locations (Sites)

Urological Research Network
Miami Lakes, Florida, 33016
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-08
Study Completion Date2033-08

Study Record Updates

Study Start Date2013-08
Study Completion Date2033-08

Terms related to this study

Keywords Provided by Researchers

  • Prostate
  • PSA
  • FUSION
  • Ultrasound
  • MRI
  • Cancer
  • Cryotherapy
  • Outcomes
  • Recurrence
  • QOL, Quality of Life
  • Urinary function
  • Sexual Function

Additional Relevant MeSH Terms

  • Neoplasms Prostate
  • Cancer of the Prostate