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Lack of funding for continuation.
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The study is a prospective, single-arm, non-randomized, unblinded trial to determine the safety and efficacy of MRI guided focal laser ablation of localized low and intermediate risk prostate cancer. All subjects meeting the inclusion exclusion criteria and are enrolled will undergo a MRI guided focal laser ablation procedure. The primary aim of the study is to study the safety and efficacy of the procedure.
Prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance has been introduced as an alternative treatment to patients with low- risk prostate cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor itself with adequate safety margin with the advantage of preserving the surrounding non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing complications.
With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious prostate gland focal lesions, determining their extent and targeting them for biopsy and focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment. Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ablation.
20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6 months, one year and two years after procedure for adverse events and recurrence of prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-guided focal laser ablation | Experimental | Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Guided Focal Laser Interstitial Thermal Ablation | Device | The procedure is done under general anesthesia. Laser fiber placement will be performed by one of two approaches (Trans gluteal or trans rectal) based on the target location within the prostate gland. When the needle position is deemed satisfactory, a 1.5-cm-active tip diode laser fiber will be introduced within an internally cooled catheter through the introducing sheath. The catheter tip location will be confirmed on Turbo Spin-Echo (TSE) T2-weighted images in the axial and sagittal oblique planes.The introducer sheath will be withdrawn to allow contact of the active laser tip with the lesion. A laser test dose will be done at 9 Watts for about 30 seconds to confirm the site of fiber placement with the subsequent delivery of full dose ablation at 12-27 Watts. Ablation duration is determined based on real time feedback of response using real time temperature and damage estimate maps. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation | Up to 12 months |
| Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Up to 24 months |
| Number of Subjects Experienced Change in Erectile Function | Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present. | 3 weeks follow up |
| Number of Subjects Experienced Change in Urinary Function | Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score > 1 indicates presence of urinary dysfunction, higher score indicates increased severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation | Up to 24 months |
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Inclusion Criteria:
Age ≥18 years
Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif G Nour, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI-guided Focal Laser Ablation | Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI-guided Focal Laser Ablation | Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation | Data were not collected/analyzed due to the study termination | Posted | Up to 12 months |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI-guided Focal Laser Ablation | Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile disfunction | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherif Nour | Emory University | 404-778-3800 | sherif.nour@emoryhealthcare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2018 | Mar 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2018 | Mar 9, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D063646 | Carcinogenesis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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Prospective, Interventional, Single-Arm, Unblinded trial
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|
| 3 weeks follow up |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Primary | Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Posted | Number | percentage of grade 3 or higher complica | Up to 24 months |
|
|
|
| Primary | Number of Subjects Experienced Change in Erectile Function | Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present. | Posted | Count of Participants | Participants | 3 weeks follow up |
|
|
|
| Primary | Number of Subjects Experienced Change in Urinary Function | Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score > 1 indicates presence of urinary dysfunction, higher score indicates increased severity. | Posted | Count of Participants | Participants | 3 weeks follow up |
|
|
|
| Secondary | Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation | Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation | Data were not collected/analyzed due to the study termination | Posted | Up to 24 months |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |