Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer (LITT)

July 23, 2020 updated by: Jonsson Comprehensive Cancer Center

Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study

This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.

Description

Inclusion Criteria:

  • Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)

    • Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA >10
    • Age 40 years to 85 years of age

    • Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a

      • Region of interest (ROI) of MRI suspicion level 3 or higher
      • ROI located proximal to the external sphincter by a margin of at least 2 cm

    • Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI

      • Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2 cores)
      • Overall Gleason score not to exceed 3+4
    • Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
    • Signed informed consent for the LITT treatment through the 12 month follow up visit

Exclusion Criteria:

  • Any significant cancer outside of MRI target (ROI) area, defined as Gleason score > 3+4
  • < 10 years life expectancy
  • American Society of Anesthesiologists (ASA) criteria of IV or higher
  • Unfit for conscious sedation anesthesia
  • Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
  • Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
  • Active urinary tract infection
  • Prostate abscess, chronic or acute prostatitis, or neurogenic bladder

  • Any prior treatment for prostate cancer

    • Radical prostatectomy
    • Radiation therapy (external beam or brachytherapy)
    • Cryotherapy
    • High intensity focused ultrasound treatment
    • Photodynamic therapy
    • Androgen deprivation therapy

  • Prior prostate, bladder neck, or urethral stricture surgery

    • Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
    • Transurethral incision of bladder neck
    • Urethral stricture dilation or reconstruction
  • Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is acceptable)
  • Prior significant rectal surgery (hemorrhoidectomy is acceptable)
  • Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
  • History of inflammatory bowel disease
  • Urinary tract or rectal fistula
  • Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laser Interstitial Thermal Therapy
This is a minimally invasive procedure for focal treatment of prostate cancer.
Device: Laser Interstitial Thermal Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Absence of prostate cancer in the MRI target area as measure of efficacy.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Pantuck Alan, MD, University of California, Los Angeles
  • Principal Investigator: Steven Raman, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2014

Primary Completion (Actual)

October 21, 2019

Study Completion (Actual)

October 21, 2019

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000409
  • JCCCID436 (Other Identifier: Jonsson Comprehensive Cancer Center)
  • NCI-2015-01487 (Other Identifier: CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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