MRI and Ultrasound Guided Cryotherapy for Prostate Cancer
Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Urological Research Network, LLC · NCT02381990
This study is testing if using MRI and ultrasound to guide cryotherapy can help men with prostate cancer get rid of their tumors while keeping side effects low and improving their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 55 Years and up |
| Sex | Male |
| Sponsor | Urological Research Network, LLC (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami Lakes, Florida) |
| Trial ID | NCT02381990 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on prostate cancer patients undergoing cryotherapy guided by multiparametric MRI, which highlights biopsy-confirmed regions of cancer. The primary goal is to assess oncological control over five years, while secondary outcomes include monitoring for disease progression and evaluating the impact on quality of life. Data collection involves comprehensive patient histories, imaging assessments, and the use of a smartphone app for patient engagement and monitoring. The study aims to effectively eradicate cancer in targeted areas while minimizing adverse effects.
Who should consider this trial
Good fit: Ideal candidates are men aged 55 to 65 with low to intermediate risk prostate cancer and less than 50% positive biopsy cores.
Not a fit: Patients with prior prostate cancer treatments or significant mental status impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cancer control and quality of life for prostate cancer patients.
How similar studies have performed: Other studies utilizing MRI and ultrasound fusion techniques have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.
Conditions: Neoplasms Prostate, Cancer of the Prostate, Prostate, PSA, FUSION, Ultrasound, MRI, Cancer