MRI/Ultrasound Fusion Guided Prostate Cryotherapy for Prostate Cancer

This study is observing men with prostate cancer who are undergoing a procedure called FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY. This procedure uses MRI (magnetic resonance imaging) scans to find the cancer, then combines that information with ultrasound in real-time. Small probes are then used to freeze and thaw the cancerous areas twice. The study is looking to see how well this treatment controls the cancer over 5, 10, and 15 years, and if the cancer spreads beyond the prostate. It also aims to see if the treatment has minimal negative effects on your quality of life. You may be able to join if you are a man aged 55 or older with low or intermediate risk prostate cancer, and the cancer has not spread outside the prostate gland. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information from 5000 participants undergoing the cryotherapy procedure. It is not a randomized or blinded study.
What's involved
Participants will have their medical history collected and may be asked to use a smartphone app to monitor their care. The study will assess cancer control for 5, 10, and 15 years after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for cancer control for 5, 10, and 15 years after the intervention.

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NCT02381990

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Recruiting
Not specifiedAges 55+Observational
Urological Research Network, LLC
~5,000 participants
Updated 2023-01-26 on ClinicalTrials.gov
What's tested:FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oncological Control
Measured over 1 Year
Neoplasms Prostate
Cancer of the Prostate
1 sites across 1 states
Florida1
  • 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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Prior treatment of prostate cancer in the form of surgery.
Performance status greater than 0 based on ECOG criteria
Mental status impairment
  • Oncological Control1 Year

    Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy