Status:
COMPLETED
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Prostate Cancer
Stage II Prostate Carcinoma
Eligibility:
MALE
45+ years
Phase:
NA
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 ligh...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01792024
Start Date
January 28 2013
End Date
September 16 2015
Last Update
March 13 2018
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470