Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness

NCT07339943 | Recruiting DMC

• 1 other identifier: 21-6189
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.

Conditions

Prostate Cancer (Adenocarcinoma); Low and Intermediate Risk Prostate Cancer

Keywords

Micro-Ultrasound Guided Focal Laser Ablation; Focal Therapy; Focal Laser Ablation; Minimally Invasive Treatment; Laser Therapy

Outcome Measures

Primary Outcomes (2)

• Primary Outcome 1:

  Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety Measure Description: Number and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer. Unit of Measure: Number of participants

  From enrollment to the end of treatment at 6 months.

• Primary Outcome 2: Technical Success Rate of MicroUS-gFLA

  Primary Outcome 2: Technical Success Rate of MicroUS-gFLA Time Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility Measure Description: Proportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and/or biopsy. Unit of Measure: Percentage of procedures

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (3)

• Secondary Outcome 1 - Change in PSA Level From Baseline

  From enrollment to the end of treatment at 6 months.

• Secondary Outcome 2: Change in Urinary Function (IPSS Score)

  From enrollment to the end of the treatment at 6 months

• Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)

  From enrollment to the end of treatment at 6 months

Study Arms (1)

Single-Arm Prospective Clinical Trial

EXPERIMENTAL

This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.

Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study; Device: The TRANBERG|CLS Thermal therapy

Interventions

6 month, prospective, interventional single-arm safety and effectiveness study PROCEDURE

x

Also known as: MicroUSgFLA treatment, Focal Laser Ablation treatment, Minimally invasive treatments for prostate cancer

Single-Arm Prospective Clinical Trial

The TRANBERG|CLS Thermal therapy DEVICE

Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy

Also known as: ExactVu Micro-Ultrasound System

Single-Arm Prospective Clinical Trial

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: Men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 40-80 years of age.
• Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
• PCa clinical stage T1c or T2.
• MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
• Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
• Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
• Prostate specific antigen (PSA) level \< 15 ng/mL.
• IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
• Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.

You may not qualify if:

• Maximum dimension of MRI/MicroUS visible tumour \> 15 mm.
• Patients medically unfit for focal therapy of the prostate.
• Patients who are unwilling or unable to give informed consent.
• Patients who have received androgen suppression therapy.
• Patients who have received or are receiving chemotherapy for prostate carcinoma.
• Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
• Patients who have undergone radiation therapy for PCa or to the pelvis.
• Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
• Patients with a history of non-compliance with medical therapy and/or medical recommendations.
• Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
• Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
• Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
• Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Exact Imaging: collaborator
• Clinical Laserthermia Systems AB: collaborator

Study Sites (1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (18)

• Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr. Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med. 2004 May 27;350(22):2239-46. doi: 10.1056/NEJMoa031918.

  PMID: 15163773 BACKGROUND

• Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24.

  PMID: 12824459 BACKGROUND

• Wenger H, Yousuf A, Oto A, Eggener S. Laser ablation as focal therapy for prostate cancer. Curr Opin Urol. 2014 May;24(3):236-40. doi: 10.1097/MOU.0000000000000044.

  PMID: 24625427 BACKGROUND

• Lindner U, Lawrentschuk N, Weersink RA, Davidson SR, Raz O, Hlasny E, Langer DL, Gertner MR, Van der Kwast T, Haider MA, Trachtenberg J. Focal laser ablation for prostate cancer followed by radical prostatectomy: validation of focal therapy and imaging accuracy. Eur Urol. 2010 Jun;57(6):1111-4. doi: 10.1016/j.eururo.2010.03.008. Epub 2010 Mar 12.

  PMID: 20346578 BACKGROUND

• Lindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14.

  PMID: 19683262 BACKGROUND

• Peters RD, Chan E, Trachtenberg J, Jothy S, Kapusta L, Kucharczyk W, Henkelman RM. Magnetic resonance thermometry for predicting thermal damage: an application of interstitial laser coagulation in an in vivo canine prostate model. Magn Reson Med. 2000 Dec;44(6):873-83. doi: 10.1002/1522-2594(200012)44:63.0.co;2-x.

  PMID: 11108624 BACKGROUND

• Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.

  PMID: 29960750 BACKGROUND

• Alibhai SM, Naglie G, Nam R, Trachtenberg J, Krahn MD. Do older men benefit from curative therapy of localized prostate cancer? J Clin Oncol. 2003 Sep 1;21(17):3318-27. doi: 10.1200/JCO.2003.09.034.

  PMID: 12947068 BACKGROUND

• Reddy D, Bedi N, Dudderidge T. Focal therapy, time to join the multi-disciplinary team discussion? Transl Androl Urol. 2020 Jun;9(3):1526-1534. doi: 10.21037/tau.2019.09.30.

  PMID: 32676440 BACKGROUND

• Langer DL, van der Kwast TH, Evans AJ, Sun L, Yaffe MJ, Trachtenberg J, Haider MA. Intermixed normal tissue within prostate cancer: effect on MR imaging measurements of apparent diffusion coefficient and T2--sparse versus dense cancers. Radiology. 2008 Dec;249(3):900-8. doi: 10.1148/radiol.2493080236.

  PMID: 19011187 BACKGROUND

• Eure G, Fanney D, Lin J, Wodlinger B, Ghai S. Comparison of conventional transrectal ultrasound, magnetic resonance imaging, and micro-ultrasound for visualizing prostate cancer in an active surveillance population: A feasibility study. Can Urol Assoc J. 2019 Mar;13(3):E70-E77. doi: 10.5489/cuaj.5361. Epub 2018 Aug 30.

  PMID: 30169149 BACKGROUND

• Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.

  PMID: 26427566 BACKGROUND

• Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12.

  PMID: 26791931 BACKGROUND

• Klotz L, Lughezzani G, Maffei D, Sanchez A, Pereira JG, Staerman F, Cash H, Luger F, Lopez L, Sanchez-Salas R, Abouassaly R, Shore ND, Eure G, Paciotti M, Astobieta A, Wiemer L, Hofbauer S, Heckmann R, Gusenleitner A, Kaar J, Mayr C, Loidl W, Rouffilange J, Gaston R, Cathelineau X, Klein E. Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. Can Urol Assoc J. 2021 Jan;15(1):E11-E16. doi: 10.5489/cuaj.6712.

  PMID: 32701437 BACKGROUND

• Johansson JE, Andren O, Andersson SO, Dickman PW, Holmberg L, Magnuson A, Adami HO. Natural history of early, localized prostate cancer. JAMA. 2004 Jun 9;291(22):2713-9. doi: 10.1001/jama.291.22.2713.

  PMID: 15187052 BACKGROUND

• McLeod DG, Iversen P, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer. BJU Int. 2006 Feb;97(2):247-54. doi: 10.1111/j.1464-410X.2005.06051.x.

  PMID: 16430622 BACKGROUND

• Ramirez AG, Trapido EJ. Advancing the Science of Cancer in Latinos. 2022 Nov 15. In: Ramirez AG, Trapido EJ, editors. Advancing the Science of Cancer in Latinos: Building Collaboration for Action [Internet]. Cham (CH): Springer; 2023. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK595808/

  PMID: 37816115 BACKGROUND

• Potosky AL, Davis WW, Hoffman RM, Stanford JL, Stephenson RA, Penson DF, Harlan LC. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004 Sep 15;96(18):1358-67. doi: 10.1093/jnci/djh259.

  PMID: 15367568 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sangeet Ghai, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateri Corr

CONTACT

416-946-4501; kateri.corr@uhn.ca

Sangeet Ghai, MD

CONTACT

416-340-4656; sangeet.ghai@uhn.ca

Study Design

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

Model Details: 6 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: January 14, 2026
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of the primary results for up to 5 years thereafter.
• Access Criteria: Data will be available to investigators with methodologically sound research proposals for use in projects related to prostate imaging, focal therapy, or outcomes research. All requestors will be required to sign a data use agreement to ensure participant confidentiality. Data requests should be submitted to the study principal investigator. Approved proposals will be granted access via a secure institutional data-sharing platform.

Locations

CA (1)