MRI-Guided Ultrasound Ablation for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen ByDavid A Woodrum, MD, PhD
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with 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. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment MRI-Guided Transurethral Ultrasound Ablation (TULSA) for prostate cancer?
Research shows that MRI-guided transurethral ultrasound ablation (TULSA) can effectively reduce prostate cancer tissue, with a study reporting a reduction of more than 75% in 8 out of 9 patients. Additionally, patients experienced no major urinary or gastrointestinal side effects, suggesting the treatment is both effective and safe for low-to-intermediate-risk prostate cancer.
12345Is MRI-guided ultrasound ablation safe for treating prostate conditions?
MRI-guided ultrasound ablation, also known as TULSA, has shown favorable safety outcomes in studies for treating localized prostate cancer, with no major urinary or gastrointestinal side effects and no changes in erectile function observed in patients.
12345How is MRI-Guided Ultrasound Ablation different from other prostate cancer treatments?
MRI-Guided Ultrasound Ablation (TULSA) is unique because it uses MRI to precisely guide ultrasound waves to heat and destroy prostate tissue, offering a minimally invasive option with potentially fewer side effects compared to traditional surgery or radiation.
12346Eligibility Criteria
Men aged 45-80 with intermediate-grade prostate cancer (Gleason grade 2 or 3) that hasn't spread beyond the prostate and is suitable for MRI. They should have a life expectancy over 10 years, no prior treatments, and be able to undergo MRI and anesthesia. Exclusions include severe urinary problems, certain implants, infections, or conditions affecting device insertion.Inclusion Criteria
My treatment plan involves targeting a small area near the urethra, confirmed by a recent MRI.
I have not received any treatment for my condition.
My prostate cancer is classified as ISUP grade 2 or 3.
My cancer is localized and has not spread to lymph nodes or other parts.
My prostate cancer is intermediate-risk with a Gleason grade of 2 or 3.
Exclusion Criteria
I currently have a urinary tract infection or prostatitis that hasn't healed.
My doctor expects I have less than 10 years to live.
I have had issues with severe bladder problems or bleeding in my urine.
My tumor is either more than 30 mm or less than 14 mm from the prostatic urethra.
I cannot have an MRI or be put under general anesthesia.
I have prostate calcifications larger than 3 mm that may interfere with tumor treatment.
I have an artificial urinary sphincter, penile implant, or intraprostatic implant.
Participant Groups
The trial tests MRI-guided TULSA for treating intermediate prostate cancer. It's less invasive than surgery and uses ultrasound to heat and destroy cancer cells. The study also assesses how this treatment affects patients' quality of life through questionnaires.
1Treatment groups
Experimental Treatment
Group I: Treatment (MRI-guided TULSA)Experimental Treatment8 Interventions
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
MRI-Guided Transurethral Ultrasound Ablation is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as TULSA for:
- Intermediate grade prostate cancer
🇨🇦 Approved in Canada as TULSA for:
- Low-grade prostate cancer
- Intermediate grade prostate cancer
🇪🇺 Approved in European Union as TULSA for:
- Localized prostate cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. [2021]Magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) is an emerging method for treatment of localized prostate cancer (PCa). TULSA-related subacute MRI findings have not been previously characterized.
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. [2018]Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity.
Magnetic resonance imaging-guided transurethral ultrasound ablation in patients with localised prostate cancer: 3-year outcomes of a prospective Phase I study. [2021]To report the 3-year follow-up of a Phase I study of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12-month safety and ablation precision were previously described.
Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. [2022]To investigate the safety and feasibility of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic obstruction (BPO).
MR Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. [2020]This report details a single-center experience of using magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) for whole-gland prostate treatment. Nine men with organ-confined low-to-intermediate-risk prostate cancer underwent the TULSA procedure. The primary endpoint of reduction of more than 75% was achieved in 8 of 9 patients, and all patients demonstrated a histologic benefit at 12-month biopsy. No major urinary or gastrointestinal side effects were observed, and there were no postprocedural changes in erectile firmness. These findings suggest that TULSA is potentially safe and efficacious for patients with low-to-intermediate-risk disease.
Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). [2022]MR-guided transurethral ultrasound ablation (TULSA) has primarily been investigated for whole-gland prostate ablation, even though the technology is also well-suited for partial gland treatment. The objectives were to perform a clinical service evaluation of partial to whole-gland TULSA for patients with localized prostate cancer (CaP). TULSA was also evaluated as a combined therapy for a subset of patients presenting with both cancer and concurrent benign prostate hyperplasia (BPH).