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New treatment option for Prostate Carcinoma
Official title MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
ClinicalTrials.gov ID: NCT05438563
What this study is testing
- What it's testing
- This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80, men only
You may be able to join if
- Male
- Age 45-80 years, with \> 10 years life expectancy
- Biopsy-confirmed, NCCN [Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3] intermediate-risk prostate cancer
- Stage =\< T2c, N0, M0
- International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8...
You likely can't join if
- Inability to undergo MRI or general anaesthesia
- Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
- Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
- Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI...
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
See the full eligibility criteria
- Male
- Age 45-80 years, with \> 10 years life expectancy
- Biopsy-confirmed, NCCN [Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3] intermediate-risk prostate cancer
- Stage =\< T2c, N0, M0
- International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore...
- Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline
- Treatment naive
- Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
- Inability to undergo MRI or general anaesthesia
- Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
- Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
- Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for...
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- Artificial urinary sphincter, penile implant or intraprostatic implant
- Less than 10 years life expectancy
- Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
- Inability or unwillingness to provide informed consent
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.