Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03650595
Brief Summary:
This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.
Detailed Description:
Study Objectives are to evaluate the proportion of patients with low-intermediate risk prostate cancer undergoing focal laser ablation (MRgFLA) prostate treatment who will be free of clinically significant Prostate Cancer (PCa), when using a \> 5mm margins around the MR visible tumor in defining the ablation contour. The rationale of the study is to show that MRgFLA is a safe procedure that can significantly postpone or eliminate the need for patients with Low-Intermediate Risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease. Study population: patients with Low-Intermediate Risk Prostate Cancer who are willing to take part in the study and meet study eligibility criteria. Primary Study Objective is to show that MRgFLA can significantly reduce the need for definitive treatment (e.g., Radical Prostatectomy, or Radiation therapy) and is a safe procedure for patients with Low-Intermediate Risk Prostate Cancer defined in the current protocol as 1) Gleason score 6 and 7 (=3+4 or 4+3; No Grade 5 pattern), and 2) T1-T2, N0, M0.
Study:
NCT03650595
Study Brief:
Protocol Section:
NCT03650595