Stopped: Business decision of the Sponsor
Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. The proposed study differs from past ones in that a trans-perineal approach with reduced risk of infection will be used in contrast to the current trans-rectal approach. In addition, high frequency micro-ultrasound imaging will be used to enhance imaging and facilitate accurate needle placement and FLA of the index lesions. The aim of this study is to evaluate FLA as a potential optimal therapeutic intervention based on safety, ease of use, efficacy, and cost.1 FLA holds promise for the management of localized tumors. The combination of the trans-perineal focal laser ablation and micro-ultrasound imaging will enable targeted trans-perineal fusion laser induced thermal therapy of prostate cancer lesions. This approach offers significant potential advantages over traditional interventions including: * Improved dynamic ultrasound imaging of the lesion to be treated compared to traditional ultrasound techniques. * Enhanced ability to visualize and spare critical structures within the prostate, including the bladder neck, neurovascular bundle (NVB), urethral sphincter and organs in close proximity including the rectum. * Sparing these structures should translate into improved preservation of ejaculation, limited changes in sexual function and minimal transient incontinence following treatment.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety and Tolerability: Number of Adverse Events Related to the Treatment
Timeframe: 12 months