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

NCT ID: NCT01792024

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-28
• Study Completion Date: 2015-09-16

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.

Conditions

Stage I Prostate Cancer; Stage II Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (LITT)

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

Group Type: EXPERIMENTAL

Visualase Thermal Therapy

Intervention Type: DEVICE

MR guided laser ablation of prostate cancer

magnetic resonance imaging

Intervention Type: PROCEDURE

Undergo MR-guided LITT

Interventions

Visualase Thermal Therapy

MR guided laser ablation of prostate cancer

Intervention Type: DEVICE

magnetic resonance imaging

Undergo MR-guided LITT

Intervention Type: PROCEDURE

Other Intervention Names

laser interstitial thermal therapy; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aytekin Oto

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Scott Eggener, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2013-00404

Identifier Type: REGISTRY

Identifier Source: secondary_id

R21CA173751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-1841

Identifier Type: -

Identifier Source: org_study_id