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

NCT03814252 | Active Not Recruiting

• 1 other identifier: T275/2018
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Localized Prostate Cancer

Keywords

Localized prostate cancer; Transurethral ultrasound ablation; Image guided; Magnetic resonance imaging guided; Lesion-targeted; Focal therapy

Outcome Measures

Primary Outcomes (2)

• Severe adverse event free survival

  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

  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 Outcomes (6)

• Urinary continence status

  3, 6 and 12 months

• Overall urinary symptom score

  3, 6 and 12 months

• Erectile function sufficient for penetration

  3, 6 and 12 months

• Overall erectile function

  3, 6 and 12 months

• Radiological failure free survival

  6 and 12 months

Study Arms (1)

Lesion-targeted ablation with MRI-TULSA

EXPERIMENTAL

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

Interventions

MRI-TULSA DEVICE

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)

Also known as: MRI guided transurethral ultrasound ablation

Lesion-targeted ablation with MRI-TULSA

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Department of Urology, VSSHP, University of Turku

Turku, Finland

Location

Related Publications (13)

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  PMID: 27626136 BACKGROUND

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  PMID: 28700844 BACKGROUND

• Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.

  PMID: 24597866 BACKGROUND

• Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.

  PMID: 27626365 BACKGROUND

• Valerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29.

  PMID: 27595377 BACKGROUND

• Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

  PMID: 28110982 BACKGROUND

• Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

  PMID: 29552975 BACKGROUND

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• Chopra R, Colquhoun A, Burtnyk M, N'djin WA, Kobelevskiy I, Boyes A, Siddiqui K, Foster H, Sugar L, Haider MA, Bronskill M, Klotz L. MR imaging-controlled transurethral ultrasound therapy for conformal treatment of prostate tissue: initial feasibility in humans. Radiology. 2012 Oct;265(1):303-13. doi: 10.1148/radiol.12112263. Epub 2012 Aug 28.

  PMID: 22929332 BACKGROUND

• Wright C, Makela P, Bigot A, Anttinen M, Bostrom PJ, Blanco Sequeiros R. Deep learning prediction of non-perfused volume without contrast agents during prostate ablation therapy. Biomed Eng Lett. 2022 Nov 8;13(1):31-40. doi: 10.1007/s13534-022-00250-y. eCollection 2023 Feb.

  PMID: 36711157 DERIVED

Study Officials

• Peter Boström, M.D.Ph.D.

  Department of Urology, VSSHP, University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: October 30, 2018
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)