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Phase II Laser Focal Therapy of Prostate Cancer (LITT or FLA)

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: NCT02243033
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Last Update Posted : March 25, 2022
Information provided by (Responsible Party):
HALO Diagnostics

Brief Summary:

Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients.

MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells.

The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach.

MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

Condition or disease Intervention/treatment
Prostate Cancer Device: MR-guided laser focal therapy

Detailed Description:

Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted thermal ablation that may offer measurable advantages over other ablative therapies for focal prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging advantage over other surgical or ablation techniques that utilize transrectal ultrasound to target and monitor treatment. MR imaging provides excellent soft-tissue contrast and three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve treatment planning and targeting. Additionally, MR-based temperature monitoring allows real-time feedback during MRI-guided thermal therapy as both deposition of light energy and MR signal acquisition can be performed simultaneously without degradation in the MR signal. Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding critical structures, MR imaging has been incorporated into planning for external- beam radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in the prostate and better target therapy.

In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies for prostate cancer used a transperineal approach; however it is now being evaluated for the primary treatment of prostate cancer using a transrectal approach. This system allows delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The system's real-time MR thermal imaging (MRTI) provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has previously not been possible with other ablative therapies. The investigators hypothesize the system can be integrated into a practical and feasible outpatient treatment paradigm for focal treatment of localized prostate cancer and allow patients to avoid the complications associated with radical whole-gland therapy.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2036
Estimated Study Completion Date : November 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
MR-guided laser focal therapy
Device: MR-guided laser focal therapy
Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.
Other Names:
  • Visualase
  • Tranberg

Primary Outcome Measures :
  1. Safety and adverse events [ Time Frame: 1 yr. post treatment ]
    Number of subjects reporting serious adverse events.

Secondary Outcome Measures :
  1. Efficacy of treatment [ Time Frame: 1 yr. post treatment ]
    MR-guided biopsy results of treated area and PSA.

Other Outcome Measures:
  1. Time to biochemical recurrence [ Time Frame: Up to 20 years ]
    PSA measurement

  2. Time to metastasis [ Time Frame: Up to 20 years ]
    Imaging utilizing PET/CT or other modality

  3. Cause of death [ Time Frame: Up to 20 years ]
    Death certificate or report from partner/spouse/primary care physician

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with prostate cancer

Inclusion Criteria:

Treatment Naïve patients:

  • Male, 45 years of age or older.
  • Diagnosis of prostate adenocarcinoma.
  • Clinical stage T1c or T2a.
  • Gleason score of 7 (3+4 or 4+3) or less.
  • Three or fewer biopsy cores with prostate cancer.
  • PSA density not exceeding 0.375.
  • One, two, or three tumor suspicious regions identified on multiparametric MRI.
  • Negative radiographic indication of extra-capsular extent.
  • Karnofsky performance status of at least 70.
  • Estimated survival of 5 years or greater, as determined by treating physician.
  • Tolerance for anesthesia/sedation.
  • Ability to give informed consent.
  • At least 6 weeks since any previous prostate biopsy.
  • MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.

Salvage candidates will be accepted upon physician referral.

Exclusion Criteria:

  • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  • Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
  • History of other primary non-skin malignancy within previous three years.
  • Diabetes
  • Smoker

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): NCT02243033

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United States, California
Desert Medical Imaging
Indian Wells, California, United States, 92210
Sponsors and Collaborators
HALO Diagnostics
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Principal Investigator: John F. Feller, MD HALO Diagnostics
Study Director: Bernadette M. Greenwood, MSc HALO Diagnostics
Additional Information:
HALODx  This link exits the ClinicalTrials.gov site

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Responsible Party: HALO Diagnostics
ClinicalTrials.gov Identifier: NCT02243033    
Other Study ID Numbers: DMI-Laser-001
WIRB Pr. No.: 20140945 ( Other Identifier: Western Institutional Review Board )
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Bi-annaually at the meetings of the International Laser Network until study closure.
Access Criteria: Scientists and physicians studying or performing laser focal therapy.
Keywords provided by HALO Diagnostics:
Prostate cancer
Focal therapy
Laser therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases