Focal Laser Ablation in Clinical Trials

By: Dan Sperling, MD

Two well-respected clinical institutions, the National Cancer Institute (NCI), and the University of Chicago Medicine (UCM), have been conducting clinical trials on Focal Laser Ablation (FLA). They are considered interventional trials, meaning that a treatment is under investigation.

Here is a little description of what each center is doing:

a)      NCI, under the sponsorship of the National Institutes of Health, informs interested patients that the purpose of their study is to test the safety and effectiveness of laser ablation, and to learn if MRI guidance improves the delivery of the treatment. Participants are carefully qualified according to study eligibility and through pre-treatment tests conducted at the site in Bethesda, MD. They are then treated using FLA. As with all clinical trials, followup is rigorous: on-site visits for physical exams, blood and urine tests, and questionnaires occur at 3, 6, 9, 12, 18, 24, and 36 months after the therapy. Participants also have MRI scans 6, 12, 24, and 36 months. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year. The study is currently not recruiting new patients, but it is ongoing as the cohort of treated patients is being followed up.

b)      The UCM completed a pilot study of 9 patients treated with transperineal FLA between Jan. 2010 and Sep. 2011. The purpose was primarily to test the feasibility and safety of FLA (a results abstract is available at http://www.ncbi.nlm.nih.gov/pubmed/23440319 ). Now they are in the midst of a Phase II study with longer follow-up of treated patients. Follow-up includes a targeted MRI-guided biopsy at 3 months after treatment (assessing undetectable cancer in the ablation zone), and another biopsy at 12 months to determine efficacy in contolling cancer. Rates and grades of treatment-related side effects are also tracked up to 12 months, as well as questionnaire evaluations of sexual and urinary quality of life. This study is also ongoing but not recruiting.

I don’t anticipate any new trials soon, but interested patients can check www.clinicaltrials.gov and enter search terms “prostate cancer laser ablation” for a list of trials. Remember that even if a trial is listed as “Recruiting” (in green letters in the left margin next to the title) it’s important to click on the title, and scroll down for eligibility requirements, location, and contact information. Interventional studies such as NCI and UCM only accept patients who are within a narrow geographic radius to insure that enrolled patients are able to make every follow-up visit.

Meanwhile, I’m eagerly awaiting the published results of these two important studies—and I hope you are, too.

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