Hemi-Gland Cryoablation for Prostate Cancer at UCLA

• Sponsor: Jonsson Comprehensive Cancer Center (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03503643
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 75.5
• Patients Per Site Per Month: 1.3

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
Prostate Cancer; Prostate Adenocarcinoma; Prostate Disease	Device: Hemigland Cryoablation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03503643
• 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: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Jonsson Comprehensive Cancer Center: prostate cancer; cryoablation
• Additional relevant MeSH terms: Prostatic Neoplasms; Prostatic Diseases

Study Results

No Results Posted as of Jan 27, 2022