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Protocol Details

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Recruitment has not started
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Thermal Therapy System;
Gleason Score

Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Cancer Institute


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.


To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.


English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.


Participants will be screened with the following:

-Medical history

-Physical exam

-Digital rectal exam

-Blood and urine tests


-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:


-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.

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Subjects must have prostate cancer, amenable for ultrasound ablation defined as following:

- diagnosed by prostate biopsies consist of transrectal ultrasound-guided standard 12 core biopsy and biopsies of one or two MRI target lesions;

- Gleason Score <= 7;

- <= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions;

- histologically positive standard biopsy cores must be from the same location in the prostate as an MRI target lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex).

- organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI imaging. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.

- PSA < 20 ng/ml.

- Adults (>= 18 years of age)

- Participants must have adequate organ and marrow function as defined below:

Platelets >= 50,000/mcL

Hemoglobin >= 8 g/dL

ALT or AST <= 5 x ULN

Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2

ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); 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.


- The presence of 3 or more MRI visible lesions positive for prostate cancer on biopsy

- Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.

- Target ablative volume of greater than 100 ml.

- Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.

- The participant is unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)

- The participant with the inability to follow up

- 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.

- Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS, renal, or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
(240) 858-3700

Michele L. Reed (Diffenderfer), R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2L324A
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6121

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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