MRI-guided ultrasound treatment for intermediate grade prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of MRI-guided transurethral ultrasound ablation (TULSA) in men aged 45 to 80 with intermediate grade prostate cancer. The procedure utilizes MRI imaging to guide ultrasound waves that target and destroy tumor cells, potentially offering a minimally invasive alternative to surgery. Participants will undergo various assessments, including quality of life metrics and follow-up evaluations over a two-year period to monitor outcomes. The study aims to provide insights into the procedure's impact on patient recovery and economic benefits.

Why it matters

Who can join: the full rules

Inclusion 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 biopsy \[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \>= 3 lesion\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
* 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

Exclusion Criteria:

* 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 calcification screening must be dated within 1 year of baseline visit
* 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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: David A Woodrum, MD, PhD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.