Hemi-Gland Cryoablation for Prostate Cancer at UCLA

• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Prostate Disease

• Registration Number: NCT03503643
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-14
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-20
• Primary Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States