Hemi-Gland Cryoablation for Prostate Cancer at UCLA

NCT03503643 | Enrolling By Invitation FDA Device

• 1 other identifier: 17-001084
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Disease

Keywords

prostate cancer; cryoablation

Outcome Measures

Primary Outcomes (1)

• Clinical Response to Cancer Treatment

  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 Outcomes (1)

• Quality of Life Assessment - Urinary Function

  6 months

Other Outcomes (1)

• Quality of Life Assessment - Erectile Function

  6 months

Interventions

Hemigland Cryoablation DEVICE

Hemigland cryoablation for the treatment of prostate cancer

Also known as: cryotherapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
• Patients unable to tolerate general or regional anesthesia.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Weiner AB, Proudfoot JA, Aker M, Cardenas M, Gonzalez S, Kelly E, Davicioni E, Sisk AE Jr, Brisbane WG, Marks LS. Genomic Biomarker for Prostate Cancer Focal Therapy: Post Hoc Assessment of a Phase II Clinical Trial. JCO Precis Oncol. 2025 Sep;9:e2500535. doi: 10.1200/PO-25-00535. Epub 2025 Sep 17.

  PMID: 40961406 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Leonard S Marks, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 20, 2018
• Study Start: September 14, 2017
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)