MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
Recruiting · NCT05241236 · Observational (researchers observe without assigning treatment) · Lead sponsor: Urological Research Network, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
What this trial is about
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 be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment
Who can take part
Age range
50 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Prior treatment of prostate cancer in the form of surgery.
- Performance status greater than 0 based on ECOG criteria
- Mental status impairment
Where it is running
1 location listed across 1 US state.
- Urological Research Network - Miami Lakes, Florida, United States