Prostate Cancer (Adenocarcinoma)MicroUSgFLANCT07339943
Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness
A study testing 6 month, prospective, interventional single-arm safety and effectiveness study and The TRANBERG|CLS Thermal therapy in people with Prostate Cancer (Adenocarcinoma) and Low and Intermediate Risk Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Low and Intermediate Risk Prostate Cancer
- What is being tested?
- 6 month, prospective, interventional single-arm safety and effectiveness study and The TRANBERG|CLS Thermal therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Kateri Corr, 416-946-4501 ext. 5501, kateri.corr@uhn.ca
Sangeet Ghai, MD, 416-340-4656, sangeet.ghai@uhn.ca
About this study
Official title: Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
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.
- Being tested
- 6 month, prospective, interventional single-arm safety and effectiveness study, The TRANBERG|CLS Thermal therapy
- Keywords
- Micro-Ultrasound Guided Focal Laser Ablation, Focal Therapy, Focal Laser Ablation, Minimally Invasive Treatment, Laser Therapy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 month, prospective, interventional single-arm safety and effectiveness studyProcedure or surgery
Also called MicroUSgFLA treatment, Focal Laser Ablation treatment, Minimally invasive treatments for prostate cancer
x
The TRANBERG|CLS Thermal therapyDevice
Also called ExactVu Micro-Ultrasound System
Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study; Device: The TRANBERG|CLS Thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (3)
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)
Measured: From enrollment to the end of treatment at 6 months.
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)
Measured: From enrollment to the end of the treatment at 6 months
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)
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start30 Apr 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Exact Imaging, Clinical Laserthermia Systems AB
- Responsible party
- Sponsor
- Investigators
- Sangeet Ghai, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339943
- Sponsor's protocol ID
- 21-6189
- Acronym
- MicroUSgFLA
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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 15163773Thompson 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 12824459Wenger 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 24625427Lindner 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 20346578Lindner 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 19683262Peters 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 11108624Guillaumier 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 29960750Alibhai 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 12947068Reddy 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 32676440Langer 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 19011187Eure 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 30169149Weinreb 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 26427566Ghai 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 26791931Klotz 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 32701437Johansson 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT07339943
- Acronym / sponsor ID
- MicroUSgFLA / 21-6189
- Keywords
- Micro-Ultrasound Guided Focal Laser Ablation, Focal Therapy, Focal Laser Ablation, Minimally Invasive Treatment, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Exact Imaging, Clinical Laserthermia Systems AB
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Prospective Clinical Trial | Experimental | Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study, Device: The TRANBERG|CLS Thermal therapyThis 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 month, prospective, interventional single-arm safety and effectiveness studyAlso: MicroUSgFLA treatment, Focal Laser Ablation treatment, Minimally invasive treatments for prostate cancerx | Procedure or surgery | Single-Arm Prospective Clinical Trial |
| The TRANBERG|CLS Thermal therapyAlso: ExactVu Micro-Ultrasound SystemMicro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy | Device | Single-Arm Prospective Clinical Trial |
Primary outcome
Primary Outcome 1:
Time frame: From enrollment to the end of treatment at 6 months.
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
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA
Time frame: From enrollment to the end of treatment at 6 months
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
3 secondary outcomes
Secondary Outcome 1 - Change in PSA Level From Baseline
Time frame: From enrollment to the end of treatment at 6 months.
Secondary Outcome 2: Change in Urinary Function (IPSS Score)
Time frame: From enrollment to the end of the treatment at 6 months
Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 15163773Thompson 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.
- Background: PubMed 12824459Thompson 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.
- Background: PubMed 24625427Wenger 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.
- Background: PubMed 20346578Lindner 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.
- Background: PubMed 19683262Lindner 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.
- Background: PubMed 11108624Peters 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.
- Background: PubMed 29960750Guillaumier 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.
- Background: PubMed 12947068Alibhai 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.
- Background: PubMed 32676440Reddy 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.
- Background: PubMed 19011187Langer 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.
- Background: PubMed 30169149Eure 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.
- Background: PubMed 26427566Weinreb 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.
- Individual participant dataSharing planned: 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).
Related trials for Prostate Cancer (Adenocarcinoma)
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruiting
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Prostate Cancer, Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sangeet Ghai, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 month, prospective, interventional single-arm safety and effectiveness study and The TRANBERG|CLS Thermal therapy in people with Prostate Cancer (Adenocarcinoma) and Low and Intermediate Risk Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kateri Corr (416-946-4501 ext. 5501, kateri.corr@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1: (time frame: From enrollment to the end of treatment at 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07339943, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.