Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 354
- Locations
- 2
- Primary Endpoint
- Clinical Response to Cancer Treatment
Study Overview
Brief Summary
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.
The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.
UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
- •Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
- •Prostate volume of ≤ 70 cc
- •Ability to complete informed consent form
Exclusion Criteria
- •Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
- •Patients unable to tolerate general or regional anesthesia.
Outcomes
Primary Outcomes
Clinical Response to Cancer Treatment
Time Frame: 6 months
Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment.
Secondary Outcomes
- Quality of Life Assessment - Urinary Function(6 months)