Prostate cancer Prostate carcinoma
Conditions
Interventions
MRI-guided transurethral ultrasoundablation of the prostate.
Sponsors
Profound Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men diagnosed with biopsy-proven, organ-confined, low- to intermediate-risk prostate cancer will be eligible for participation in this study, provided they have not received prior treatment of their prostate cancer.
Exclusion criteria
Exclusion criteria: Extraprostatic extension, lesion within 3mm of the urethra or sphincter plane, previous TURP, calcifications or cysts in the prostate, use of hormones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Safety Endpoint: Frequency and severity of adverse events deemed related or possibly related to the TULSA-PRO device, procedure, or ablative process will be evaluated and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI). * Efficacy Endpoint: Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir * 25% of the pre-treatment baseline value. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Adverse Event Endpoint: Frequency and severity of all adverse events, described using the NCI CTCAE. * Erectile Dysfunction Endpoint: Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with erection firmness sufficient for penetration (IIEF item 2 * 2). * Urinary Incontinence Endpoint: Rate of urinary incontinence, determined by the change from baseline of the proportion of patients who use one or more pads per day (EPIC item 5 * 1). * PSA Nadir Endpoint: Proportion of patients achieving PSA nadir * 0.5 ng/ml. * PSA Stability Endpoint: Proportion of patients with PSA * 0.5 ng/ml at the most recent follow-up visit. * Prostate Volume Endpoint: Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits. * Prostate Biopsy Endpoint: Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by TRUS-guided 10-core biopsy. * IPSS Endpoint: Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit. * IIEF Endpoint: Change in the Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction domains of the International Index of Erectile Function (IIEF-15), between the baseline and most recent follow-up visit. * EPIC Endpoint: Change in Urinary, Bowel, Sexual and Hormonal domains of the Expanded Prostate Cancer Index Composite (EPIC), between the baseline and most recent follow-up visit. * Targeting Accuracy Endpoint: Conformal prostate ablation, measured quantitatively between the target prostate volume and the target temperature isotherm on MRI thermometry acquired during the TULSA-PRO procedure, and described using three measures of targeting accuracy: o Dice Similarity Coefficient (DSC * unitless from 0 to 1), is a statistical validation metric to measure the degree of spatial overlap between two regions [Dice 1945]. o Over- | — |
Countries
Netherlands
Outcome results
None listed