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MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Stage I Prostate Cancer, Stage II Prostate Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualase Thermal Therapy
magnetic resonance imaging
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Prostate Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical characteristics:

    • Stage T1c or T2a
    • Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) < 0.15 ng/ml^3

  • No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:

    • Bone scan if PSA > 20 ng/ml and clinical stage T1c
    • Bone scan if PSA > 10 ng/ml and clinical stage T2

  • Biopsy requirements:

    • Gleason score 7 or less
    • 25% or fewer biopsies with cancer
    • At least 12 biopsy cores of the prostate
    • Within 12 months of treatment

  • Imaging requirements:

    • Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
    • MRI within 6 months of treatment
  • Karnofsky performance status of at least 70
  • General health is suitable to undergo the planned minimally invasive procedures
  • Risks, benefits, and alternatives discussed with informed consent given

Exclusion Criteria:

  • Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
  • Presence of 3 or more visible lesions on MRI
  • High suspicion of seminal vesicle invasion or lymph node metastases on MRI
  • Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
  • Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
  • History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
  • Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (LITT)

Arm Description

Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.

Outcomes

Primary Outcome Measures

Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

Secondary Outcome Measures

The Number of Patients With Biopsy Cancer of the Treatment Zone
A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
The Total Number of Patients With Any Adverse Events Related to the Treatment
Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.

Full Information

First Posted
February 12, 2013
Last Updated
February 13, 2018
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01792024
Brief Title
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Official Title
Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2013 (Actual)
Primary Completion Date
September 16, 2015 (Actual)
Study Completion Date
September 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment. SECONDARY OBJECTIVES: I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone. II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment. OUTLINE: Patients undergo MR-guided LITT. After completion of study treatment, patients are followed up at 1, 3, and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Cancer, Stage II Prostate Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (LITT)
Arm Type
Experimental
Arm Description
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
Intervention Type
Device
Intervention Name(s)
Visualase Thermal Therapy
Other Intervention Name(s)
laser interstitial thermal therapy
Intervention Description
MR guided laser ablation of prostate cancer
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo MR-guided LITT
Primary Outcome Measure Information:
Title
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
Description
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
Time Frame
At 3 months after ablation
Secondary Outcome Measure Information:
Title
The Number of Patients With Biopsy Cancer of the Treatment Zone
Description
A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
Time Frame
At 12 months
Title
The Total Number of Patients With Any Adverse Events Related to the Treatment
Description
Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame
1,3, and 12 month after treatment and up to 12 months
Title
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)
Description
International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
Time Frame
At 1,3 and 12 months
Title
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
Description
Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.
Time Frame
At 1,3 and 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical characteristics: Stage T1c or T2a Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) < 0.15 ng/ml^3 No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines: Bone scan if PSA > 20 ng/ml and clinical stage T1c Bone scan if PSA > 10 ng/ml and clinical stage T2 Biopsy requirements: Gleason score 7 or less 25% or fewer biopsies with cancer At least 12 biopsy cores of the prostate Within 12 months of treatment Imaging requirements: Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s) MRI within 6 months of treatment Karnofsky performance status of at least 70 General health is suitable to undergo the planned minimally invasive procedures Risks, benefits, and alternatives discussed with informed consent given Exclusion Criteria: Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation Presence of 3 or more visible lesions on MRI High suspicion of seminal vesicle invasion or lymph node metastases on MRI Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other) Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aytekin Oto
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Eggener, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

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MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

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