Phase II Laser Focal Therapy of Prostate Cancer (LITT or FLA)
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|ClinicalTrials.gov Identifier: NCT02243033|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Last Update Posted : March 25, 2022
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
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.
- Safety and adverse events [ Time Frame: 1 yr. post treatment ]Number of subjects reporting serious adverse events.
- Efficacy of treatment [ Time Frame: 1 yr. post treatment ]MR-guided biopsy results of treated area and PSA.
- Time to biochemical recurrence [ Time Frame: Up to 20 years ]PSA measurement
- Time to metastasis [ Time Frame: Up to 20 years ]Imaging utilizing PET/CT or other modality
- Cause of death [ Time Frame: Up to 20 years ]Death certificate or report from partner/spouse/primary care physician
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
|United States, California|
|Desert Medical Imaging|
|Indian Wells, California, United States, 92210|
|Principal Investigator:||John F. Feller, MD||HALO Diagnostics|
|Study Director:||Bernadette M. Greenwood, MSc||HALO Diagnostics|