This pilot clinical trial studies focal (targeted) radio-frequency ablation in treating patients with prostate cancer that is inside the prostate (localized) and has not spread to nearby lymph nodes or tissue. Radio-frequency ablation is an image-guided technique that heats and destroys cancer cells and may be effective in treating patients with localized prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02328807.
PRIMARY OBJECTIVES:
I. Investigate the role of focal bipolar radio-frequency ablation (RFA) in a defined prostate cancer population examining treatment efficacy (elimination of the cancer) based on repeat biopsy at six months from treatment.
SECONDARY OBJECTIVES:
I. Changes from baseline in quality-of-life.
II. Image characteristics of treated prostate cancer by bipolar RFA.
III. To evaluate the safety of the procedure.
TERTIARY OBJECTIVES:
I. Evaluate the health economic impact of focal RFA.
OUTLINE:
Patients undergo bipolar RFA via the ENCAGE™ RFA system under transrectal ultrasound guidance.
After completion of study treatment, patients are followed up at 6 weeks and at 3 and 6 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorJulio M. Pow-Sang
