Status:
RECRUITING
MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
Lead Sponsor:
Urological Research Network, LLC
Conditions:
Neoplasms Prostate
Cancer of the Prostate
Eligibility:
MALE
50+ years
Brief Summary
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will b...
Detailed Description
CLINICAL REGISTRY OBSERVATION NATURE This serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed pr...
Eligibility Criteria
Inclusion
- Men between 50 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
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2038
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT05241236
Start Date
November 15 2020
End Date
November 1 2038
Last Update
January 26 2023
Active Locations (1)
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1
Urological Research Network
Miami Lakes, Florida, United States, 33016