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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01792024
First received: February 12, 2013
Last updated: March 11, 2014
Last verified: March 2014

February 12, 2013
March 11, 2014
January 2013
February 2015   (final data collection date for primary outcome measure)
Undetectable cancer on MRI-guided biopsy of ablation zone following treatment [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01792024 on ClinicalTrials.gov Archive Site
  • Oncologic efficacy following treatment based on biopsy of the treatment zone [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
PHASE II EVALUATION OF MR-GUIDED LASERINDUCED 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
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage I Prostate Cancer
  • Stage II Prostate Carcinoma
  • Procedure: laser interstitial thermal therapy
    Other Name: MR guided laser ablation of prostate cancer
  • Procedure: magnetic resonance imaging
    Undergo MR-guided LITT
    Other Names:
    • MRI
    • NMR imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
Experimental: Treatment (LITT)
Patients undergo MR-guided laser ablation of prostate cancer
Interventions:
  • Procedure: laser interstitial thermal therapy
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
27
February 2015
February 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
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01792024
12-1841, NCI-2013-00404
No
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
March 2014

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