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

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ClinicalTrials.gov Identifier: NCT01792024
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Description
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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

Condition or disease Intervention/treatment Phase
Stage I Prostate Cancer Stage II Prostate Carcinoma Device: Visualase Thermal Therapy Procedure: magnetic resonance imaging Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
Actual Study Start Date : January 28, 2013
Actual Primary Completion Date : September 16, 2015
Actual Study Completion Date : September 16, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (LITT)
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
 Device: Visualase Thermal Therapy
MR guided laser ablation of prostate cancer
Other Name: laser interstitial thermal therapy

Procedure: magnetic resonance imaging
Undergo MR-guided LITT
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment [ Time Frame: At 3 months after ablation ]
    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 :
  1. The Number of Patients With Biopsy Cancer of the Treatment Zone [ Time Frame: At 12 months ]
    A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.

  2. The Total Number of Patients With Any Adverse Events Related to the Treatment [ Time Frame: 1,3, and 12 month after treatment and up to 12 months ]
    Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  3. Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) [ Time Frame: At 1,3 and 12 months ]
    International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.

  4. Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) [ Time Frame: At 1,3 and 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792024


Locations
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United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aytekin Oto University of Chicago Comprehensive Cancer Center
Principal Investigator: Scott Eggener, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01792024    
Other Study ID Numbers: 12-1841
NCI-2013-00404 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R21CA173751 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2013    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases