Sound waves vs. prostate cancer: new MRI-Guided treatment tested
NCT ID NCT04808427
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 9 times
Summary
This study tests a procedure called TULSA that uses MRI images to guide high-energy ultrasound waves to destroy prostate cancer tumors. About 21 adults with early-stage prostate cancer that shows up on MRI will receive this heat-based treatment. The goal is to see if the approach is safe and feasible, with follow-up over three years to monitor results.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Subjects must have prostate cancer amenable for ultrasound ablation defined as: * diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI; * Gleason Score \<= 7; * MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group \>= 2 prostate cancer must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). Systematic and targeted cores of Grade Group 1 prostate cancer outside of proposed ablation zone do not affect inclusion status, as these can be observed by conventional guideline management. * organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible. * PSA \< 20 ng/ml or PSA \>20 with a PSA density \<0.15. * Adults (\>= 18 years of age) * Participants must have adequate organ and marrow function as defined below: Platelets \>= 50,000/mcL Hemoglobin \>= 8 g/dL Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\* \>= 30 mL/min/1.73 m\^2 GFR=glomerular filtration rate; ULN=upper limit of normal. \*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard. * Subjects must be able to understand and willing to sign a written informed consent document. * Subjects must be co-enrolled to NCI protocol 16-C-0010 "Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue." EXCLUSION CRITERIA: * Targeted lesion ablation length from apex to base of \>5 cm or lesion extending \>3 cm from the urethra. * Target ablation volume greater than 100 ml. * Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target. * Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.) * Acute urinary tract infection * Lower urinary tract symptoms defined by an IPSS \> 20 * Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation (within time frame) that would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Light-Based imaging aims to spot prostate cancer left behind after surgery
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer