Recruiting

MicroUSgFLA

Sponsor:

University Health Network, Toronto

Code:

NCT07339943

Conditions

Prostate Cancer (Adenocarcinoma)

Low and Intermediate Risk Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

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

The TRANBERG|CLS Thermal therapy

Study Details

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

Study ID

NCT07339943

Start date

Apr 30, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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 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)

Study Design

Enrollment

7 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

x

The TRANBERG|CLS Thermal therapy

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

Primary outcome measure

  • Primary Outcome 1: [ Time Frame: From enrollment to the end of treatment at 6 months. ]
  • Primary Outcome 2: Technical Success Rate of MicroUS-gFLA [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Kateri Corr

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

Sangeet Ghai, MD

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

Locations

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Kateri Corr

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

Sangeet Ghai, MD

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

Principal Investigator:

Sangeet Ghai, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-01-14.