Hemi-Gland Cryoablation for Prostate Cancer at UCLA
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03503643|
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2018
Last Update Posted : November 27, 2020
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|
|Prostate Cancer Prostate Adenocarcinoma Prostate Disease||Device: Hemigland Cryoablation|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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 :||September 15, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
- Device: Hemigland Cryoablation
Hemigland cryoablation for the treatment of prostate cancerOther Name: cryotherapy
- Clinical Response to Cancer Treatment [ Time Frame: 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.
- Quality of Life Assessment - Urinary Function [ Time Frame: 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.
- Quality of Life Assessment - Erectile Function [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503643
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Leonard S Marks, MD||University of California, Los Angeles|