MRI Guided Prostate Cancer Focal Laser Ablation

NCT03634579 | Terminated Results DMC FDA Device

• 1 other identifier: IRB00094958
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Cancer/Carcinogenesis; Laser Treatment; Magnetic Resonance Imaging (MRI); Radiology

Outcome Measures

Primary Outcomes (4)

• 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.

  3 weeks follow up

Secondary Outcomes (1)

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

  Up to 24 months

Study Arms (1)

MRI-guided focal laser ablation

EXPERIMENTAL

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

Device: MRI Guided Focal Laser Interstitial Thermal Ablation

Interventions

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.

MRI-guided focal laser ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Carcinogenesis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sherif Nour
• Organization: Emory University

sherif.nour@emoryhealthcare.org

404-778-3800

Study Officials

• Sherif G Nour, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Model Details: Prospective, Interventional, Single-Arm, Unblinded trial

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 16, 2018
• Study Start: June 1, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (1)