MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Completed · Not applicable
Conditions studied: Stage I Prostate Cancer, Stage II Prostate Carcinoma
In brief
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
Key facts
- Study ID
- NCT01792024
- Run by
- University of Chicago
- People needed
- 27
- Starts
- 2013-01-28
- Expected to finish
- 2015-09-16
- Last updated by the study team
- 2018-03-13
Who can join
Age: 45 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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