MRI and Ultrasound Guided Cryotherapy for Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.