Hemi-Gland Cryoablation for Prostate Cancer at UCLA

Jonsson Comprehensive Cancer Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hemigland Cryoablation

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Observational Model:
Time Perspective:
Official Title:
Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
Actual Study Start Date :
Sep 14, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Clinical Response to Cancer Treatment [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 Outcome Measures

  1. Quality of Life Assessment - Urinary Function [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.

Other Outcome Measures

  1. Quality of Life Assessment - Erectile Function [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.

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90095

Sponsors and Collaborators

  • Jonsson Comprehensive Cancer Center


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 17-001084
First Posted:
Apr 20, 2018
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by Jonsson Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022