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

A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Indian Wells, California, United States, 92210
      • Desert Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Visualase; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and adverse events	Number of subjects reporting serious adverse events.	1 yr. post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment	MR-guided biopsy results of treated area and PSA.	1 yr. post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to biochemical recurrence	PSA measurement	Up to 20 years
Time to metastasis	Imaging utilizing PET/CT or other modality	Up to 20 years
Cause of death	Death certificate or report from partner/spouse/primary care physician	Up to 20 years

Collaborators and Investigators

• Sponsor: HALO Diagnostics
• Investigators: Principal Investigator: John F. Feller, MD, Halo Diagnostics; Study Director: Bernadette M. Greenwood, MSc, Halo Diagnostics

Publications and helpful links

General Publications

• Greenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.
• Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.
• Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.
• Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.

Helpful Links

• HALODx

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2036
• Study Completion (ANTICIPATED): November 1, 2036

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (ESTIMATE): September 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Prostate cancer; Transrectal; Focal therapy; Laser therapy; MRI-guided
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: DMI-Laser-001; WIRB Pr. No.: 20140945 (OTHER: Western Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication
• IPD Sharing Time Frame: Bi-annaually at the meetings of the International Laser Network until study closure.
• IPD Sharing Access Criteria: Scientists and physicians studying or performing laser focal therapy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF