Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer (PRO-TULSA-PC)

September 16, 2025 updated by: Turku University Hospital

Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer

Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from injury, which may improve the outcome of genitourinary function. This study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Improving diagnostic methods and screening of men with prostate specific antigen (PSA) has led to earlier detection of prostate cancer (PCa) with more favorable disease characteristics. To decrease overtreatment, low risk cases are increasingly treated with active surveillance; nevertheless some of them progress requiring interventions. Intermediate- and high-risk cases need active treatments to improve survival. However, despite desirable local control, the standard therapies including radical prostatectomy and radiation therapy, carry a risk of treatment related adverse effects to genitourinary and bowel functions. There is an eminent need for efficient PCa therapies with minimal effect on genitourinary function and quality of life. To date most studied mini-invasive technologies have used extremities of temperatures to treat PCa including high intensity focused ultrasound and cryoablation.

Magnetic resonance imaging (MRI) has improved PCa diagnosis. Novel MRI techniques enable localization and visualization of clinically significant PCa. Further, MRI can be used for guidance of targeted biopsy from suspicious lesion enhancing detection of clinically significant PCa and pinpointing a target for image guided therapies. Also, increased use of MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet need for image guided therapies.

MRI guided transurethral ultrasound ablation (MRI-TULSA) - treatment system offers treatment strategy incorporating precise diagnosis and targeted therapy. It has been evaluated for whole-gland ablation of localized PCa. Further, lesion-targeted MRI-TULSA has been proved to be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant PCa in our phase 1 treat-and-3-week-resect study (not published yet). This current study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Department of Urology, VSSHP, University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Language spoken: Finnish, English or Swedish
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
  • Biopsy-confirmed acinar adenocarcinoma of the prostate
  • Gleason score ≥ 3+4/International Society of Urological Pathology grade group ≥ 2
  • High volume Gleason score 6 as determined on biopsies (>2 positive cancer core or ≥ 50% cancer in a core)
  • Patient presenting low volume Gleason score 6 disease and refuses active surveillance
  • Non-metastatic disease; high-risk patients according to European Association of Urology risk group stratification will undergo F-Prostate specific membrane antigen-Positron Emission Tomography/Computer Tomography to exclude distant metastasis
  • Lesion visible on MRI (Prostate Imaging Reporting and Data System v2 4-5)
  • Eligible for general anesthesia (American Society of Anesthesiologists (ASA)≤ 3)

Exclusion Criteria:

  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)

    • Acute unresolved urinary tract infection
    • Claustrophobia
    • Hip replacement surgery or other metal in the pelvic area
    • Known allergy to gadolinium
    • Inability to insert urinary catheter
    • Suspected tumor on baseline MRI further than 30 mm or within 3 mm of the prostatic urethra
    • Prostate calcifications or cysts obstructing planned ultrasound beam path within the targeted tissue volume
    • Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lesion-targeted ablation with MRI-TULSA
Intervention: Targeted lesion based thermoablation of MRI-visible biopsy proven clinically significant prostate cancer. Ablative effect is aimed to cover lesion with 5 mm MRI based healthy tissue overlap wherever possible but not compromising viability of critical tissues, mainly the wall of rectum.
Device: MRI-TULSA

The technology is developed to ablate targeted prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.

TULSA-PRO (Profound Medical Inc, Toronto, Canada): PAD-105, integrated into a 3 Tesla MR-system (Ingenia 3.0 Tesla, Philips Healthcare, Best, Netherlands)

Other Names:
  • MRI guided transurethral ultrasound ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe adverse event free survival
Time Frame: 3 months
The primary safety outcome is the freedom from severe adverse events over 3 months follow up: Clavien Dindo Classification of surgical complication is graded from 1 (mild) to 5 (death). Severe adverse events are regarded as events graded ≥3.
3 months
Oncological efficacy: Disease free survival
Time Frame: 12 months
The primary oncological efficacy outcome, disease free survival (DFS), is the freedom from any histologically proven clinically significant prostate cancer as assessed from both 10-12-core systematic biopsies and MRI-directed 2-4-core in field biopsies at 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary continence status
Time Frame: 3, 6 and 12 months
Urinary continence status as measured by Expanded Prostate Cancer Index Composite (EPIC) item 5 ≥ 2 (patient filled and reported outcome measure)
3, 6 and 12 months
Overall urinary symptom score
Time Frame: 3, 6 and 12 months
Symptom severity as measured by International Prostate Symptom Score (IPSS) (patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.
3, 6 and 12 months
Erectile function sufficient for penetration
Time Frame: 3, 6 and 12 months
Erectile dysfunction status as measured by International Index of Erectile Function item 2 ≥ 2 (erection firmness sufficient for penetration)(patient filled and reported outcome measure). Not applicable for subject with baseline score < 2.
3, 6 and 12 months
Overall erectile function
Time Frame: 3, 6 and 12 months
Erectile function as measure by International Index of Erectile Function-5 (IIEF-5)(patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.
3, 6 and 12 months
Radiological failure free survival
Time Frame: 6 and 12 months
Presence of a highly suspicious lesion in treatment field on prostate MRI at 6 or 12 months (Likert suspicion level ≥ 4).
6 and 12 months
Ablation failure free survival
Time Frame: 12 months
In field (ablated area) biopsy-confirmed histologically viable cancer.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Peter Boström, M.D.Ph.D., Department of Urology, VSSHP, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2018

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T275/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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