Finding studies
Finding studies
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Lead
Genesis Research LLC
Device: TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer A perineal local anesthesia block is performed with the patient in lithotomy. The micro-ultrasound, secured to a digital stepper, is inserted and advanced. The live ultrasound image is displayed on the micro-ultrasound machine. The urologist advances the laser fiber introducer, temperature probes, and laser fiber to desired positions in the prostate using micro-ultrasound guidance. One laser fiber will be used for single or multiple treatment applications. Target treatment is achieved once the laser applicator position is confirmed. The urologist will instruct on the desired treatment parameters to be entered into the TRANBERG® console. Real-time monitoring of the ablation zone will be done using the micro-ultrasound and temperature probes. Once the individual treatment has been completed, the applicator will be relocated to the next location, if necessary. Patients will be discharged home with instructions and contact information once stable. Primary Outcome Measures: The primary objective of this study is to assess the safety \& tolerability of a tandem approach using micro-ultrasound imaging for FLA in patients with organ confined localized low or favorable intermediate risk Prostate Cancer. The secondary objectives are to evaluate the efficacy of FLA in ablating the index tumor lesion, as well as clinical outcomes: erectile and sexual function as well as urinary control. In addition, volumetric changes in prostate lesions, prostate size as well as cancer control in treated areas will be assessed by both imaging (mpMRI) and pathology (prostate needle biopsy). Additional secondary objectives include: * Determine the presence or absence of csPCa in the index lesion ablation zone (in- treatment field) at the 12 month post procedure biopsy. * Evaluate the ability of high frequency micro-ultrasound imaging to identify the mpMRI. detected index lesion in the prostate. * Evaluate the ability of micro-ultrasound to image the index lesion ablation size and compare ablation sizes using post procedure MRI. * Determine the cost-benefit effectiveness of the treatment with trans-perineal focal laser ablation in office treatment under local anesthesia supplement with Nitrous Oxide sedation. * Evaluate duration of treatment using trans-perineal focal laser ablation.
Age
40–85
Sex
MALE
Healthy volunteers
Not accepted
