Hemi-Gland Cryoablation for Prostate Cancer at UCLA

May 19, 2026 updated by: Jonsson Comprehensive Cancer Center

Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are candidates for hemi-gland cryoablation, and elect this treatment option as a standard of care procedure, will be considered for our clinical study and analysis of their outcomes. Subjects will provide informed consent to participate in this study during standard of care clinical visits at the Clark Urology Center at UCLA. Subjects will provide informed consent to allow study staff to abstract data from their medical records.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessment - Urinary Function
Time Frame: 6 months
Comparison of urinary function pre- and post-treatment will be obtained using the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall urinary function assessments.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessment - Erectile Function
Time Frame: 6 months
Comparison of erectile function pre- and post-treatment will be obtained using the 5-Item International Index of Erectile Function (IIEF-5) Sexual Health Inventory for Men and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall erectile function assessments.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Leonard S Marks, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

August 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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