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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 : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Leonard S. Marks, M.D., University of California, Los Angeles

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
Prostate Cancer Prostate Adenocarcinoma Prostate Disease Device: Hemigland Cryoablation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at UCLA
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Device: Hemigland Cryoablation
    Hemigland cryoablation for the treatment of prostate cancer
    Other Name: cryotherapy


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA from a start date of 1/1/2017 to an end date of 12/31/2018
  • Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer on no more than 2 biopsy cores and maximum cancer core lengths on biopsy of ≤ 8 mm).
  • PSA ≤ 20
  • Prostate volume of ≤ 70 cc
  • Ability to complete informed consent form

Exclusion Criteria:

  • Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  • Medical contraindication to follow-up mpMRI or prostate biopsy
  • Patients unable to tolerate general or regional anesthesia.
  • Positive bone scan (if done or clinically indicated).

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Leonard S Marks, MD University of California, Los Angeles

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Responsible Party: Leonard S. Marks, M.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03503643    
Other Study ID Numbers: 17-001084
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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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 Leonard S. Marks, M.D., University of California, Los Angeles:
prostate cancer
cryoablation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type