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MRI-guided focal laser ablation for prostate cancer

Focal laser ablation

Yvonne Wimper

Jurgen Fütterer

Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments.

This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®\|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.

Prostate cancer is the most frequent non-cutaneous malignancy in the western male population, with almost 13,600 newly diagnosed patients in the Netherlands in 2019. Due to widespread use of the prostate-specific antigen (PSA) test and the lowered PSA threshold for biopsy, the number of newly diagnosed prostate cancers strongly increased in the last 20 years.

At present, treatment choice for prostate cancer patients at low or intermediate risk of disease progression lies between active surveillance (AS) and radical therapies, such as radical prostatectomy or radiotherapy. For these patients, radical treatments have a comparable effectiveness, with a risk of specific death of less than 1% in 15 years. However, none is devised of consequences on the quality of life and can induce significant morbidities such as incontinence and impotence.

For this reason, innovative ablation techniques such as cryosurgery, high intensity focused ultrasound, photodynamic therapy and laser ablation therapy have emerged and are increasingly applied in clinical practice. These treatment methods aim for local destruction of cancerous cells using various sources of energy. The main advantage of preservation of healthy prostatic tissue is to reduce treatment-related complications and morbidity. Recent studies demonstrate that post-treatment prognosis is predominantly driven by the largest lesion with the highest grade, the so-called 'index lesion'. Treatment approaches which preserve parts of the prostatic gland are considered as focal therapy. Imaging plays an important role in detection, localization, targeting and monitoring of focal prostate cancer treatment. Multi-parametric magnetic resonance imaging (mpMRI) is preferred in detecting and staging prostate cancer due to excellent soft tissue contrast and multiplanar anatomical imaging. It is also used to differentiate between post-treatment changes and potential recurrent or residual disease. As such, secondary treatment can be promptly established. More recently, mpMRI has gained acceptance in image-guided therapeutic settings since it offers real-time anatomical imaging in different planes and therefore improved treatment accuracy. Furthermore it can provide real-time temperature imaging.

Focal laser ablation (FLA) or laser-induced interstitial thermal therapy (LITT) is a relatively new technique which was originally developed to treat brain tumors. During this therapy, a laser fiber is positioned into the tumor under image guidance (ultrasound or MRI). When the position of the fiber is correct, laser light is delivered through the fiber and the temperature of the tissue around the tip of the fiber increases. When temperature increases above 60°C the tissue is irreversibly damaged and destroyed. The total ablation process takes about 2-3 minutes. MRI is perfectly suited to use for image guidance during FLA, because it can be used to localize the tumor, target it with probes, monitor and control the ablation procedure in real-time and to map tissue temperature.

Only a few studies on MRI-guided FLA are known. Lepor et al provided a pilot study of 25 patients with low-intermediate risk prostate cancer undergoing FLA. Three months after treatment, they showed no significant differences in functional outcome according to the SHIM (Sexual Health in Man) and AUASS (American Urological Association Symptom Score) questionnaires and no incontinence. Furthermore, 96% of the ablation zones targeted with biopsy three months after treatment, showed no histopathological prove of residual prostate cancer. A recent study by Walser et al. demonstrated a freedom of retreatment rate of 83% after a one year follow up in a group of 120 men with low- to intermediate risk disease that underwent transrectal FLA with no significant changes in quality of life or sexual and urinary function.

In Radboudumc we have several years of experience with MRI-guided focal laser ablation for prostate cancer treatment. At this moment separate systems are used for MR thermometry (IFE, Siemens) and laser energy control (Biolitec). CLS offers a dedicated system which integrates laser energy control with MR thermometry for ablation monitoring. Next to this, additional types of laser fibers are available that are thought to produce relatively larger, more adequate ablation zones (up to 3.0 x 2.0 cm) in comparison to current fibers. In potential, this will decrease the total procedure time because less ablations per lesion are needed and more patients will be eligible for FLA because larger tumors can be treated.

This project has the purpose to assess the feasibility of MRI-guided FLA treatment using the newly developed CLS system as well as its usability and safety.

MRI-guided Focal Laser Ablation Prostate Cancer

Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

completion of laser ablation without technical failures, achievement of complete ablation shown by MRI after treatment calculated using image co-registration software, total procedure time, total numver of fiber positions and ablations needed

procedure-related adverse events and complications following SIR criteria

measured with MRI 6 months after treatment

Radboud University Medical Center

All patient will undergo focal ablation of prostate tissue utilizing laser energy.

Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance

Focal Laser Ablation

Leonard Marks, MD

This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.

Focal Laser Ablation of Prostate Tissue

Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance

Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.

MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.

Jean Perkins Foundation

Medtronic

Jonsson Comprehensive Cancer Center

The Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy.

Orion system to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region.

Allan Pantuck, M.D.

The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

The primary objective is to evaluate the safety and feasibility of MR-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events. In addition, changes in health-related quality of life (HRQOL) will be evaluated using Expanded Prostate Index Composite for Clinical Practice (EPIC-CP), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Decision Regret Scale.

This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the Orion System. In this study, the investigators intend to use the investigational Orion system to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. Subjects will return to clinic 1 week, 1 month, and every 3 months until one year post-FLA to be monitored for adverse events and complete Health Related Quality of Life (HRQOL) questionnaires. Biomarker (PSA) kinetics will also be monitored.

This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the focal laser ablation (FLA) Orion System. Men with histologically confirmed, non-metastatic, prostate adenocarcinoma, clinical stage ≤ T2b, with Gleason score 7 by MRI-ultrasound fusion targeted biopsy, without history of prior treatment and without neoadjuvant radiation or hormone therapy, who desire focal treatment with laser ablation will be enrolled.

eligibility based on physical existence of prostate.

Focal Laser Ablation of Prostate Cancer

Office-based Focal Laser Ablation of Prostate Cancer: An Early Feasibility Study Using MRI/US Image Fusion for Guidance

Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.

National Cancer Institute (NCI)

MR-guided focal laser ablation

Jurgen Futterer, MD, PhD

Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

MR-guided Focal Laser Ablation of the Prostate

The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.

Canisius-Wilhelmina Hospital

Ziekenhuisgroep Twente

Annemarijke van Luijtelaar, MD

Joyce Bomers, PhD

Jurgen Fütterer, MD, PhD

Michiel Sedelaar, MD,PhD

Michiel Sedelaar, MD, PhD

Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.

MRI-guided Focal Laser Ablation

The investigators will be author of submitted manuscripts in case they fulfill criteria for authorship according to regulations of scientific journals. After scientific publication of the results the study protocol, relevant data and findings will be made publically available for other centers to implement (parts) of this research into their standard clinical practice if they wish to do so.

To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).

To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.

To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS)

To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)

To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ).

To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25).

To evaluate the complication rate related to the technique

Biolitec

Soteria Medical

Siemens Corporation, Corporate Technology

Echolaser X4 system

J R Oddens, MD, PhD

Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration.

The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement.

This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia.

This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.

Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis

Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone

Safety is assessed by device and procedural adverse events using the CTCAE v5.0 until radical prostatectomy. TPLA is definitely safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher. Technical feasibility is determined by procedural success of the TPLA treatment.

TPLA is definitely feasible when ≥90% of procedures is performed successfully without any problems regarding needle placement, fibre introduction or device malfunctioning.

Determination of the size of the ablated area

Ablation zone volumes are measured using CEUS and mpMRI and these are used to determine ablation zone compared to histopathological changes. Visual changes are identified and described.

Determination of short-term functional outcomes following TPLA treatment

Elesta S.R.L.

Amsterdam UMC, location VUmc

The Netherlands Cancer Institute

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Head of Urology department

After inserting the laser, a thermal-optical probe will be inserted via a multichannel needle guide or tranperineal grid in the prostate using transrectal ultrasound guidance. The sensor probe will be placed at a pre-determined depth and location based on the treatment zone. Targets will be identified prior to laser treatment using multi-parametric MRI and delineated by the radiologist for visualization by the treatment operator. The lesion will be visible both on a 3D reconstruction and during real-time ultrasound imaging. Applications of laser energy up to 15 watts of power will be used to treat the target region. Confirmation of appropriate laser position will be made with real-time ultrasound prior to application of laser energy and repeatedly during activation of the laser. Energy delivery will be planned specific to each patient's tumor geometry, with the assistance of the Avenda Health Unfold-AI Software.

Removal of cancerous tissue through the direct application of laser energy

Wayne Brisbane, MD

This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with UnfoldAI. In this study, the investigators intend to use the UnfoldAI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate. Subjects will be assessed at 1 week, 1 month, and every 3 months until one-year post-FLA treatment(s) to be monitored for adverse events and complete quality-of-life questionnaires.

The Avenda Health FocalPoint System (K201687) is a laser-based interstitial irradiation/thermal soft-tissue ablation system that is FDA 510(k) cleared for surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties. The Avenda Health Unfold-AI Software (K221624) is an Artificial Intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow that is also FDA 510(k) cleared. The Unfold-AI Software will be utilized along with the FocalPoint System and is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. This feasibility investigation will determine whether the FocalPoint System used with Unfold-AI can be used to ablate prostate tissue in men with prostate cancer while leaving critical structures (urethra, rectal wall) undamaged.

This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with Unfold-AI. In this study, the investigators intend to use the Unfold-AI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. Subjects will be assessed at 1 week, 1 month, and every 3 months until one-year post-FLA treatment(s) to be monitored for adverse events and complete HRQOL questionnaires. Post-treatment MRI findings, fusion biopsy results and biomarker (PSA) kinetics will also be monitored. Subjects eligible for repeat FLA (re-ablation) are those who still continue to meet Inclusion and Exclusion Criteria at Months 6 or 12 post-FLA treatment (See Sections 3.0 Inclusion Criteria, 4.0 Exclusion Criteria, and 6.4.7 Repeat FLA (re-ablation)). Subjects may undergo only one re-ablation on the study.

This study will cover pre-treatment through 12 months following FLA treatment or repeat FLA (re-ablation) treatment. The study also has a long-term follow-up data collection period of up to 10 years following a subject's last study visit.

The primary endpoint will be safety. Safety will be determined by the number, type, and severity of adverse events incurred by subjects.

the investigators intend to use Focal Laser Ablation guided by the UnfoldAI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate.

Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance

adverse event data will be monitored and tabulated. The primary study endpoint will be achieved by the absence of any Grade 3 or higher adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI-guided Focal Laser Ablation Prostate Cancer	NCT05370482	Prostate Neopla...	Focal laser abl...	45 Years - 76 Years	Radboud University Medical Center
Focal Laser Ablation of Prostate Tissue	NCT02357121	Prostate Cancer	Focal Laser Abl...	40 Years - 85 Years	Jonsson Comprehensive Cancer Center
Focal Laser Ablation of Prostate Cancer	NCT04305925	Prostate Cancer	Focal Laser Abl...	40 Years - 85 Years	Jonsson Comprehensive Cancer Center
MR-guided Focal Laser Ablation of the Prostate	NCT02200809	Prostate Cancer MRI Focal Laser Abl...	MR-guided focal...	18 Years -	Radboud University Medical Center
MRI-guided Focal Laser Ablation	NCT04379362	Prostate Cancer	Focal laser abl...	45 Years - 76 Years	Radboud University Medical Center
Transperineal Laser Ablation for Focal Treatment of Prostate Cancer	NCT04170478	Prostate Cancer Focal Laser Abl... Transperineal L...	Echolaser X4 sy...	40 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
MRI-guided Focal Laser Ablation	NCT04379362	Prostate Cancer	Focal laser abl...	45 Years - 76 Years	Radboud University Medical Center
Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance	NCT06047509	Prostate Cancer	Focal Laser Abl...	40 Years - 85 Years	Jonsson Comprehensive Cancer Center
Focal Laser Ablation of Prostate Cancer	NCT04305925	Prostate Cancer	Focal Laser Abl...	40 Years - 85 Years	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for focal laser ablation