Hemi-Gland Cryoablation for Prostate Cancer at UCLA

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03503643
• Other study ID #: 17-001084
• Status: Enrolling by invitation
• Start date: September 14, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Disease
• Prostatic Diseases
• Prostatic Neoplasms

Intervention

Device:
• Hemigland Cryoablation
Hemigland cryoablation for the treatment of prostate cancer

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Assessment - Erectile Function	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
Primary	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	Quality of Life Assessment - Urinary Function	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