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Trial record 83 of 2746 for:    prostate cancer AND Cancer | ( Map: United States )

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

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.

Condition or disease Intervention/treatment
Prostate Cancer Device: Laser Interstitial Thermal Therapy

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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
Actual Study Start Date : August 11, 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Absence of prostate cancer in the MRI target area as measure of efficacy. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.
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)

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): NCT02224911


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Pantuck Alan, MD University of California, Los Angeles
Principal Investigator: Steven Raman, MD University of California, Los Angeles

Publications:
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02224911     History of Changes
Other Study ID Numbers: LITT Treatment
14-000409 ( Other Identifier: UCLA IRB )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2018
Keywords provided by Jonsson Comprehensive Cancer Center:
focal therapy
prostate cancer treatment
laser treatment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases