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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03503643
Other study ID # 17-001084
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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