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MRI/Ultrasound Fusion Guided Prostate Cryotherapy

NCT02381990 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-01-26

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins

Sponsors & Collaborators

  • Urological Research Network, LLC

    lead OTHER

Principal Investigators

  • FERNANDO J BIANCO, MD · UROLOGICAL RESEARCH NETWORK

  • EUSEBIO LUNA, MD · UROLOGICAL RESEARCH NETWORK

  • Isabel H Lopez, MD · UROLOGICAL RESEARCH NETWORK

Eligibility

Min Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2023-08-31
Completion
2033-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381990 on ClinicalTrials.gov