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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

February 12, 2013
February 15, 2013
December 22, 2017
March 13, 2018
March 13, 2018
January 28, 2013
September 16, 2015   (Final data collection date for primary outcome measure)
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.
Undetectable cancer on MRI-guided biopsy of ablation zone following treatment [ Time Frame: At 3 months ]
Complete list of historical versions of study NCT01792024 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • 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.
  • 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.
  • Oncologic efficacy following treatment based on biopsy of the treatment zone [ Time Frame: At 12 months ]
  • Rates and grades of treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 12 months ]
  • Quality of life in terms of urinary and sexual function in the year following treatment assessed using the International Prostate Symptom Score (IPSS) and Sexual Health Inventory in Men (SHIM) [ Time Frame: Up to 12 months ]
Not Provided
Not Provided
 
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
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

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stage I Prostate Cancer
  • Stage II Prostate Carcinoma
  • 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
Experimental: Treatment (LITT)
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
Interventions:
  • Device: Visualase Thermal Therapy
  • Procedure: magnetic resonance imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Same as current
September 16, 2015
September 16, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
45 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01792024
12-1841
NCI-2013-00404 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R21CA173751 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of Chicago
University of Chicago
National Cancer Institute (NCI)
Principal Investigator: Aytekin Oto University of Chicago Comprehensive Cancer Center
Principal Investigator: Scott Eggener, MD University of Chicago
University of Chicago
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP