Focal Laser Ablation of Prostate Tissue (FLA)
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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: NCT02357121 |
Recruitment Status :
Completed
First Posted : February 6, 2015
Last Update Posted : September 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Device: Focal Laser Ablation | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance |
Actual Study Start Date : | September 17, 2015 |
Actual Primary Completion Date : | August 20, 2019 |
Actual Study Completion Date : | August 20, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Laser ablation
All patient will undergo focal ablation of prostate tissue utilizing laser energy.
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Device: Focal Laser Ablation
Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
Other Name: laser treatment |
- safety of focal laser treatment using LITT: Number of participants with adverse events [ Time Frame: 12 months ]Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
- Efficacy of focal laser ablation of prostate tissue using the LITT system. [ Time Frame: 12 months ]MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.

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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 |
Inclusion Criteria
- Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason ≤ 3+4)
- 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
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Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
- Region of interest (ROI) of MRI suspicion level 3 or higher
- MRI-calculated prostate volume 25cc to 100cc
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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
- Overall Gleason score not to exceed 3+4
- Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- Signed informed consent for the FLA treatment through the 12 month follow up visit.
Exclusion Criteria:
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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
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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
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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 ≥ 3 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
- Inflammatory bowel disease
- Urinary tract or rectal fistula
- Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)

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): NCT02357121
United States, California | |
UCLA | |
Los Angeles, California, United States, 90095 | |
University of California Los Angeles | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Leonard Marks, MD | University of California at Los Angeles |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT02357121 |
Other Study ID Numbers: |
15-000018 JCCCID534 ( Other Identifier: Jonsson Comprehensive Cancer Center ) |
First Posted: | February 6, 2015 Key Record Dates |
Last Update Posted: | September 21, 2020 |
Last Verified: | April 2020 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |