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Prostate CarcinomaNCT05438563

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

A study testing MRI-Guided Transurethral Ultrasound Ablation, Questionnaire Administration and Digital Rectal Examination in people with Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

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Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 80 years, men only
What is being tested?
MRI-Guided Transurethral Ultrasound Ablation, Questionnaire Administration and Digital Rectal Examination
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
6 Apr 2022to 7 Dec 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trial Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    David A. Woodrum, MD, PhD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) low to intermediate-risk prostate cancer.

SECONDARY OBJECTIVE:

  1. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

OUTLINE:

Patients undergo MRI-guided TULSA. Patients may also undergo digital rectal exam (DRE), cystoscopy, biopsy, bone scan, prostate specific membrane antigen (PSMA) positron emission tomography (PET), and/or multiparametric MRI (mpMRI) at screening.

After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.

Being tested
MRI-Guided Transurethral Ultrasound Ablation, Questionnaire Administration, Digital Rectal Examination, Cystoscopy, Biopsy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI-Guided Transurethral Ultrasound AblationProcedure or surgery

    Also called MRI-TULSA

    Undergo MRI-Guided TULSA

  • Questionnaire AdministrationOther

    Ancillary studies

  • Digital Rectal ExaminationProcedure or surgery

    Also called DRE

    Undergo DRE

  • CystoscopyProcedure or surgery

    Also called CS

    Undergo cystoscopy

  • BiopsyProcedure or surgery

    Also called Bx, BIOPSY_TYPE

    Undergo biopsy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET

  • Multiparametric Magnetic Resonance ImagingProcedure or surgery

    Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

    Undergo mpMRI

Study groups in NCT05438563
Study groupRoleWhat they receive
Treatment (MRI-guided TULSA)ExperimentalPatients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Receives: Procedure: MRI-Guided Transurethral Ultrasound Ablation; Other: Questionnaire Administration; Procedure: Digital Rectal Examination; Procedure: Cystoscopy; Procedure: Biopsy; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: Multiparametric Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients free from treatment failure

    Failure is defined as: delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy); or metastatic disease; or prostate cancer-specific death.

    Measured: At 24 months post-treatment

  2. Proportion of patients who maintain both urinary continence and erectile potency

    Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite [EPIC]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated.

    Measured: At 12 months

Secondary outcomes (12)

  1. Biochemical failure

    In the absence of a validated threshold for biochemical failure in the setting of ablative therapies, the Phoenix criteria will be adopted for the transurethral ultrasound ablation (TULSA) procedure (nadir + 2 ng/mL). Prostate-specific antigen (PSA) is measured at baseline/procedure, 3, 6, 9, 12, 15, 18, 21, and 24 months. It's measured using Scale Grade Group 1, 2, 3, and 4.

    Measured: Up to 24 months

  2. Histologic failure

    The proportion of patients with clinically significant disease on targeted +/- systematic biopsy at 12 months. Clinically significant disease is defined as Gleason grade group 2 or higher. It is measured using scale Grade Group 1, 2, 3, and 4.

    Measured: At 12 months

  3. Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion

    These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured using Pi-Rads 1-5, 1 being most likely not cancer to 5 being very suspicious.

    Measured: At 24 months post-treatment

  4. Total prostate volume

    These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured.

    Measured: At 24 months post-treatment

  5. Salvage-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  6. Biochemical failure-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  7. Histologic failure-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  8. Metastasis-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  9. Prostate cancer-specific survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  10. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  11. Change in quality of life

    Change from baseline in the EPIC questions 1-7 domains and in the visual analog score will be measured at baseline, 6, 12, 18, and 24 months using Scale Grade Group 1, 2, 3, and 4.

    Measured: Baseline up to 24 months

  12. Change in patient-reported genitourinary function

    Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4.

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start6 Apr 2022
  3. Primary completion7 Jul 2028 (estimated)
  4. Study completion7 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438563
Sponsor's protocol ID
22-001336
Status last verified
Jul 2026
First submitted
20 May 2022
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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