RECRUITING

MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer

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Conditions

Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.

Official Title

Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System

Quick Facts

Study Start:2022-04-06
Study Completion:2027-03-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05438563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male
  2. * Age 45-80 years, with \> 10 years life expectancy
  3. * Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer
  4. * Stage =\< T2c, N0, M0
  5. * 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
  6. * Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline
  7. * Treatment naive
  8. * Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
  1. * Inability to undergo MRI or general anaesthesia
  2. * Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
  3. * Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
  4. * 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
  5. * Unresolved urinary tract infection or prostatitis
  6. * History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
  7. * Artificial urinary sphincter, penile implant or intraprostatic implant
  8. * Less than 10 years life expectancy
  9. * Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
  10. * Inability or unwillingness to provide informed consent
  11. * History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

David A Woodrum, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • David A Woodrum, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-06
Study Completion Date2027-03-07

Study Record Updates

Study Start Date2022-04-06
Study Completion Date2027-03-07

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8