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

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: NCT02224911
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date July 21, 2014
First Posted Date August 25, 2014
Last Update Posted Date April 22, 2019
Actual Study Start Date August 11, 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2014)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02224911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 21, 2014)
Absence of prostate cancer in the MRI target area as measure of efficacy. [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer
Official Title Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.
Condition Prostate Cancer
Intervention Device: Laser Interstitial Thermal Therapy
Study Groups/Cohorts Laser Interstitial Thermal Therapy
This is a minimally invasive procedure for focal treatment of prostate cancer.
Intervention: Device: Laser Interstitial Thermal Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 21, 2014)
8
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02224911
Other Study ID Numbers LITT Treatment
14-000409 ( Other Identifier: UCLA IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor Jonsson Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Pantuck Alan, MD University of California, Los Angeles
Principal Investigator: Steven Raman, MD University of California, Los Angeles
PRS Account Jonsson Comprehensive Cancer Center
Verification Date April 2018