## Protocol Section
### Identification Module
**NCT ID:** NCT03634579

**Brief Title:** MRI Guided Prostate Cancer Focal Laser Ablation

**Official Title:** Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation of Localized Prostate Cancer

#### Organization Study ID Info
**ID:** IRB00094958
#### Organization
**Class:** OTHER
**Full Name:** Emory University
### Status Module
#### Completion Date
**Date:** 2019-03-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-23

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-09

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2019-03-15

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-03-23

**Type:** ACTUAL

**Results First Submit Date:** 2020-03-09

**Results First Submit QC Date:** 2020-03-09

#### Start Date
**Date:** 2018-06-01

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2018-08-16
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-19
**Study First Submit QC Date:** 2018-08-15
**Why Stopped:** Lack of funding for continuation.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Emory University

#### Responsible Party

**Investigator Affiliation:** Emory University

**Investigator Full Name:** Sherif G. Nour

**Investigator Title:** Associate Professor of Radiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- Cancer/Carcinogenesis

- Laser Treatment

- Magnetic Resonance Imaging (MRI)

- Radiology

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective, Interventional, Single-Arm, Unblinded trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.

**Intervention Names:**

- Device: MRI Guided Focal Laser Interstitial Thermal Ablation

**Label:** MRI-guided focal laser ablation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MRI-guided focal laser ablation

**Description:** 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.

**Name:** MRI Guided Focal Laser Interstitial Thermal Ablation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation

**Time Frame:** Up to 12 months

**Description:** 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.

**Measure:** 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

**Time Frame:** Up to 24 months

**Description:** 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.

**Measure:** Number of Subjects Experienced Change in Erectile Function

**Time Frame:** 3 weeks follow up

**Description:** 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:** Number of Subjects Experienced Change in Urinary Function

**Time Frame:** 3 weeks follow up

#### Secondary Outcomes

**Description:** 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

**Measure:** Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation

**Time Frame:** Up to 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years
* Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7

  * Lesions visible on multiparametric MRI and subsequently diagnosed by targeted MRI guided biopsy

Exclusion Criteria:

* Multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non- contiguous pathologically proven foci of cancer.
* Gleason score \>4+3=7.
* Extracapsular spread.
* Nodal or distant metastasis
* Contraindications to MRI or general anesthesia.
* Uncorrectable Coagulopathy.
* Refusal of participation.
* Lesions not visualized on the multiparametric MRI

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University Hospital

**State:** Georgia

**Zip:** 30322

#### Overall Officials

**Official 1:**

**Affiliation:** Emory University

**Name:** Sherif G Nour, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-05-08

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 797645

- Type Abbrev: Prot_SAP

- Upload Date: 2020-03-09T12:46

- Date: 2018-05-05

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 274708

- Type Abbrev: ICF

- Upload Date: 2020-03-09T12:52

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M30145

- Name: Carcinogenesis

- Relevance: LOW

- As Found: Unknown

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** MRI-guided Focal Laser Ablation

**Deaths Num At Risk:** 9

**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 9

**Serious Number At Risk:** 9

**Title:** MRI-guided Focal Laser Ablation

**Frequency Threshold:** 0

#### Other Events

**Term:** Erectile disfunction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** 

**Term:** Urinary incontinence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Time Frame:** 2 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 9

**Units:** Participants

### Group

**ID:** BG000

**Title:** MRI-guided Focal Laser Ablation

**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** sherif.nour@emoryhealthcare.org
**Organization:** Emory University
**Phone:** 404-778-3800
**Title:** Sherif Nour
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Population Description:** Data were not collected/analyzed due to the study termination
**Reporting Status:** POSTED
**Time Frame:** Up to 12 months
**Title:** Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation
**Type:** PRIMARY
##### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** OG000
**Title:** MRI-guided Focal Laser Ablation
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 24 months
**Title:** 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
**Type:** PRIMARY
**Unit of Measure:** percentage of grade 3 or higher complica
##### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** OG000
**Title:** MRI-guided Focal Laser Ablation
#### Outcome Measure 3
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 3 weeks follow up
**Title:** Number of Subjects Experienced Change in Erectile Function
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** OG000
**Title:** MRI-guided Focal Laser Ablation
#### Outcome Measure 4
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 3 weeks follow up
**Title:** Number of Subjects Experienced Change in Urinary Function
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** OG000
**Title:** MRI-guided Focal Laser Ablation
#### Outcome Measure 5
**Description:** 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
**Population Description:** Data were not collected/analyzed due to the study termination
**Reporting Status:** POSTED
**Time Frame:** Up to 24 months
**Title:** Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation
**Type:** SECONDARY
##### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** OG000
**Title:** MRI-guided Focal Laser Ablation
### Participant Flow Module
#### Group
**Description:** Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
**ID:** FG000
**Title:** MRI-guided Focal Laser Ablation
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** study termination
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
**Has Results:** True