NCT02381990Recruiting
MRI/Ultrasound Fusion Guided Prostate Cryotherapy
Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 12 Jan 2015
- Start date
- 1 Aug 2013
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- Urological Research Network, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT02381990
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Aug 2013 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment of prostate cancer in the form of surgery.
Other illness
- Mental status impairment
Other
- Performance status greater than 0 based on ECOG criteria
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urological Research Network Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.