A Phase II Study to Evaluate Magnetic Resonance Image-guided Laser Therapy for Prostate Cancer, a 5-year Survival Study
ABOUT THIS STUDY
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
· Male, 45 years of age or older.
· Diagnosis of prostate adenocarcinoma.
· Clinical stage T1c or T2a.
· Gleason score of 7 (3+4 or 4+3) or less.
· PSA density less than 0.375. One, two, or three tumor suspicious regions identified on multiparametric MRI
· Negative radiographic indication of extra-capsular extent.
· A Karnofsky performance status of at least 70.
· Estimated survival of 5 years or greater, as determined by treating physician.
· Tolerance for anesthesia/sedation.
· Ability to give informed consent.
· At least 6 weeks since any previous prostate biopsy.
· MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason Score of 7 (3+4 or 4+3) or less.
· Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
· Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater.
· History of other primary non-skin malignancy within previous three years.
Study statuses change often. Please contact us for help.
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Open, single center, non-randomized, uncontrolled
We’ll be happy to answer your questions about the trial