Focal Prostate Ablation Utilizing TULSA Profound System

Overview

About this study

The primary hypotheses are that the TULSA-Procedure is safe and effective treatment of intermediate grade prostate cancer over 2 years. The primary endpoint is defined as the proportion of patients who maintain urinary continence and erectile potency. The effectiveness co-primary endpoint is defined as the proportion of patients free from treatment failure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male patients.
  • Age 45-80 years, with > 10 years life expectancy.
  • Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
  • Stage ≤ T2c, N0, M0.
  • ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
  • PSA ≤ 20 ng/mL reported within 3 months of baseline.
  • Treatment naïve.
  • 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.
  • Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic 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 calcifications. 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 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.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Woodrum, M.D., Ph.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Desirae Howe-Clayton

(507) 255-0111

Howe.Desirae@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions