ClinicalTrials.gg
RecruitingNCT07339943MicroUSgFLAUpdated Sep 25, 2026

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

An interventional study of 6 month, prospective, interventional single-arm safety and effectiveness study and The TRANBERG|CLS Thermal therapy in Prostate Cancer (Adenocarcinoma) and Low and Intermediate Risk Prostate Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2025, registered Sep 2025).
  • Started Apr 2025; still recruiting 1 year 6 months later.
Updated Sep 25, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
40 Years to 85 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 101 studies in Prostatic Neoplasms by University Health Network, Toronto — 22 open to participants now, 28 under way, 2 of them phase 3. Prostatic Neoplasms · University Health Network, Toronto.

Planned enrollment
80th of 85
7 · median 48
Started
2025
with 4 others
No phase
43 of 101
12 open now
Primary completion
2028-05
later than 12 of 27 live
Registered
98th of 101
by date

Among the 101 studies in Prostatic Neoplasms by University Health Network, Toronto, this one is the 80th largest by planned enrollment of the 85 interventional ones that give a count, is one of 5 that started in 2025, is one of 43 with no phase, reaches primary completion later than 12 of the 27 other live ones, and was the 98th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

22 of the 101 studies in Prostatic Neoplasms by University Health Network, Toronto are open now, in 1 country. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 22 open studies →

Where they have run

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 40 Years to 85 Years · male · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 101 studies in Prostatic Neoplasms by University Health Network, Toronto, or all of them as a file.
02

Study 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.

Read the detailed description

Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men 40-80 years of age.
  • -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 .
  • Prostate specific antigen (PSA) level \< 15 ng/mL.
  • IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
  • of greater than 10 years, based on co-morbidity not related to PCa.

Exclusion criteria

Exclusion Criteria:

  • 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 .
  • 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 treatment and/or product within the past 90 days.
  • Patients with to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (estimated)

Study arms

  • Experimental
    Single-Arm Prospective Clinical Trial

    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

  • Procedure6 month, prospective, interventional single-arm safety and effectiveness study

    x

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

  • DeviceThe TRANBERG|CLS Thermal therapy

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrollment to the end of treatment at 6 months.

  2. 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

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. Secondary Outcome 1 - Change in PSA Level From Baseline

    Secondary Outcome 1 - Change in PSA Level From Baseline Time Frame: Baseline to 6 months Outcome Type: Efficacy Measure Description: Change in serum prostate-specific antigen (PSA) level from baseline prior to ablation to 6-month follow-up. Unit of Measure: Change in PSA (ng/mL)

    Time frame: From enrollment to the end of treatment at 6 months.

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

    Secondary Outcome 2: Change in Urinary Function (IPSS Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in urinary function measured using the International Prostate Symptom Score (IPSS). Unit of Measure: Change in score (IPSS scale)

    Time frame: From enrollment to the end of the treatment at 6 months

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

    Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in erectile function measured using the International Index of Erectile Function-15 (IIEF-15) questionnaire. Unit of Measure: Change in score (IIEF-15 scale)

    Time frame: From enrollment to the end of treatment at 6 months

07

Study locations

1 of 1 sites recruiting
  • University Health Network - Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
    • Kateri Corr · Contactkateri.corr@uhn.ca · 416-946-4501
    • Sangeet Ghai, MD · Contactsangeet.ghai@uhn.ca · 416-340-4656
    • Sangeet Ghai, MD · Principal investigator
    • Nathan Perlis, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 15163773 ↗
  • 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. PubMed 12824459 ↗
  • 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. PubMed 24625427 ↗
  • 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. PubMed 20346578 ↗
  • 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. PubMed 19683262 ↗
  • 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. PubMed 11108624 ↗
  • 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. PubMed 29960750 ↗
  • 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. PubMed 12947068 ↗
  • 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. PubMed 32676440 ↗
  • 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. PubMed 19011187 ↗
  • 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. PubMed 30169149 ↗
  • 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. PubMed 26427566 ↗
  • 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. PubMed 26791931 ↗
  • 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. PubMed 32701437 ↗
  • 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. PubMed 15187052 ↗
  • 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. PubMed 16430622 ↗
  • 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/ PubMed 37816115 ↗
  • 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. PubMed 15367568 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — De-identified individual participant data that relate to the results reported in the primary publication (e.g., baseline demographics, imaging findings, treatment parameters, outcomes, and adverse events).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for May 2028, 37 months after the start.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 37 months is below that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion May 2026 → May 2028 and completion Dec 2027 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2025
First posted
Jan 14, 2026
StartActual
Apr 30, 2025
Primary completionEst.
May 31, 2028was May 2026
CompletionEst.
Dec 31, 2028was Dec 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
May 31, 2026→May 31, 2028
Sep 25, 2026
Study completion
Dec 31, 2027→Dec 31, 2028
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Primary completion May 31, 2026→May 31, 2028
    Study completion Dec 31, 2027→Dec 31, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07339943
Collaborators
Exact Imaging, Clinical Laserthermia Systems AB
Responsible party
Sponsor
First posted
Jan 14, 2026
Start date
Apr 30, 2025
Primary completion
May 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Kateri Corr
Contact
kateri.corr@uhn.ca
416-946-4501 ext. 5501
Sangeet Ghai, MD
Contact
sangeet.ghai@uhn.ca
416-340-4656
Sangeet Ghai, MD
principal investigator · The Princess Margaret Cancer Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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