Prostate CancerNCT04808427
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
A study testing TULSA-PRO in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TULSA-PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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."
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods.
Read more
Objective:
To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.
Eligibility:
English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.
Design:
Participants will be screened with the following:
- Medical history
- Physical exam
- Digital rectal exam
- Blood and urine tests
- Electrocardiogram
- Tumor biopsy
- Questionnaire to assess urinary tract symptoms
- MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner.
Participants may also be screened with the following:
- Echocardiogram
- Chest x-ray
- Bone scan
- Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
- MRI of the brain
- Transrectal ultrasound
- Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body.
Some screening tests will be repeated during the study.
Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum.
Participants will use a urethral catheter for 1-7 days.
Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.
Read the detailed description
Background:
Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or "indolent" cancer which poses little threat to life or health.
We propose that participants with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.
Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser.
Objective:
To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)
Eligibility:
Subjects with prostate cancer, amenable for ultrasound ablation
Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy
Adequate organ and marrow function
Prostate-specific antigen (PSA) < 20 ng/ml
Age >=18 years
Design:
Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer.
It is anticipated that 15 participants will be evaluated for this study.
- Conditions
- Prostate Cancer
- Being tested
- TULSA-PRO
- Keywords
- TULSA, Thermal Therapy System, PSA, Gleason Score
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TULSA-PRODevice
Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate
| Study group | Role | What they receive |
|---|---|---|
| 1/Arm 1 | Experimental | Ultrasound ablation of focal prostate cancer Receives: Device: TULSA-PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and tolerability
To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)
Measured: 3, 6, 12, 18, 24, and 36 months
Secondary outcomes (5)
safety and tolerability
Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively
Measured: 3, 6, 12, 18, 24, and 36 months
changes in imaging and biopsy characteristics
Determine if focal ablation of MRI visible, biopsy-confirmed prostate cancer using the TULSA Thermal Therapy System (Profound Medical) platform can successfully ablate targeted prostate cancer lesions in >50% of participants
Measured: 3, 6, 12, 18, 24, and 36 months
effect of thermal ablation on short- and long-term complication rates
Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure
Measured: 3, 6, 12, 18, 24, and 36 months
thermal damage
Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure
Measured: 3, 6, 12, 18, 24, and 36 months
outcome of TULSA ablation
Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)
Measured: 3, 6, 12, 18, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start20 Nov 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Why it stopped: On hold pending consideration of an amendment to increase recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808427
- Sponsor's protocol ID
- 210017
- Other IDs
- 21-C-0017
- Status last verified
- 13 Oct 2026
- First submitted
- 19 Mar 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04808427
- Acronym / sponsor ID
- 210017
- Conditions
- Prostate Cancer
- Keywords
- TULSA, Thermal Therapy System, PSA, Gleason Score
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: On hold pending consideration of an amendment to increase recruitment.
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods.
Objective:
To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.
Eligibility:
English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.
Design:
Participants will be screened with the following:
- Medical history
- Physical exam
- Digital rectal exam
- Blood and urine tests
- Electrocardiogram
- Tumor biopsy
- Questionnaire to assess urinary tract symptoms
- MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner.
Participants may also be screened with the following:
- Echocardiogram
- Chest x-ray
- Bone scan
- Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
- MRI of the brain
- Transrectal ultrasound
- Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body.
Some screening tests will be repeated during the study.
Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum.
Participants will use a urethral catheter for 1-7 days.
Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.
Detailed description
Background:
Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or "indolent" cancer which poses little threat to life or health.
We propose that participants with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.
Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser.
Objective:
To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)
Eligibility:
Subjects with prostate cancer, amenable for ultrasound ablation
Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy
Adequate organ and marrow function
Prostate-specific antigen (PSA) < 20 ng/ml
Age >=18 years
Design:
Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer.
It is anticipated that 15 participants will be evaluated for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Arm 1 | Experimental | Device: TULSA-PROUltrasound ablation of focal prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TULSA-PROTransurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate | Device | 1/Arm 1 |
Primary outcome
feasibility and tolerability
Time frame: 3, 6, 12, 18, 24, and 36 months
To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)
5 secondary outcomes
safety and tolerability
Time frame: 3, 6, 12, 18, 24, and 36 months
changes in imaging and biopsy characteristics
Time frame: 3, 6, 12, 18, 24, and 36 months
effect of thermal ablation on short- and long-term complication rates
Time frame: 3, 6, 12, 18, 24, and 36 months
thermal damage
Time frame: 3, 6, 12, 18, 24, and 36 months
outcome of TULSA ablation
Time frame: 3, 6, 12, 18, 24, and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Pinto, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TULSA-PRO in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility and tolerability (time frame: 3, 6, 12, 18, 24, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.