Laser ablation treatment for prostate cancer using MRI and ultrasound guidance
Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry
This study is testing how well a new laser treatment for prostate cancer works when guided by MRI and ultrasound, while also looking at how it affects patients' urinary and sexual function over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Urological Research Network, LLC Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami Lakes, Florida) |
| Trial ID | NCT05241236 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an observational registry aimed at recording the outcomes of patients treated with targeted laser ablation for biopsy-confirmed prostate cancer. It evaluates short, intermediate, and long-term results, focusing on procedure-related tolerability, perioperative adverse events, oncological control, and functional outcomes such as urinary and sexual function. The study will assess the effectiveness of MRI and ultrasound fusion in guiding the laser ablation process and will monitor for cancer recurrence and metastasis over time.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 to 65 with low or intermediate risk prostate cancer and less than 50% positive biopsy cores.
Not a fit: Patients with prior prostate cancer treatments or those with significant mental status impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive treatment option for prostate cancer with improved outcomes and fewer side effects.
How similar studies have performed: While this approach is innovative, similar studies using image-guided techniques for prostate cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami Lakes, Florida
- Urological Research Network — Miami Lakes, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Fernando J Bianco, Md — Urological Research Network
- Study coordinator: Cielo D Guerra, Bs
- Email: CIELO@BESTUROLOGY.NET
- Phone: 305-515-9887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.