NCT04808427

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
15mo left

Started Nov 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Nov 2023Sep 2027

First Submitted

Initial submission to the registry

March 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

November 26, 2025

Status Verified

November 24, 2025

Enrollment Period

3.4 years

First QC Date

March 19, 2021

Last Update Submit

November 25, 2025

Conditions

Prostate Cancer

Keywords

TULSAThermal Therapy SystemPSAGleason Score

Outcome Measures

Primary Outcomes (1)

  • 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)

    3, 6, 12, 18, 24, and 36 months

Secondary Outcomes (5)

  • safety and tolerability

    3, 6, 12, 18, 24, and 36 months

  • changes in imaging and biopsy characteristics

    3, 6, 12, 18, 24, and 36 months

  • effect of thermal ablation on short- and long-term complication rates

    3, 6, 12, 18, 24, and 36 months

  • thermal damage

    3, 6, 12, 18, 24, and 36 months

  • outcome of TULSA ablation

    3, 6, 12, 18, 24, and 36 months

Study Arms (1)

1/Arm 1

EXPERIMENTAL

Ultrasound ablation of focal prostate cancer

Device: TULSA-PRO

Interventions

TULSA-PRODEVICE

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

1/Arm 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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."

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter A Pinto, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen K Holcomb

CONTACT

(240) 974-9026karen.holcomb@nih.gov

Peter A Pinto, M.D.

CONTACT

(240) 858-3700pp173u@nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 22, 2021

Study Start

November 20, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11-24

Data Sharing

IPD Sharing
Will share

All IPD recorded in the medical record will be shared with intramural investigators upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Clinical data available during the study and indefinitely.
Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US(1)