Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
MALE
NCT07339943

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

Led by University Health Network, Toronto · Updated on 2026-01-14

7

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

E

Exact Imaging

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 40 to 80 years
  • Histologically confirmed intermediate-risk prostate cancer with Gleason score 7 and primary grade 4 or less
  • Clinical stage T1c or T2 prostate cancer
  • Suspicious lesion on MRI or Micro-Ultrasound located in one prostate lobe
  • Visible tumor on MRI or Micro-Ultrasound measuring 15 mm or less
  • Suspicious MRI or Micro-Ultrasound site matches positive biopsy sector
  • Prostate specific antigen (PSA) level below 15 ng/mL
  • Completed urinary, incontinence, and sexual function questionnaires before procedure
  • Life expectancy greater than 10 years unrelated to prostate cancer
Not Eligible

You will not qualify if you...

  • Tumor visible on MRI or Micro-Ultrasound larger than 15 mm
  • Medically unfit for focal prostate therapy
  • Unable or unwilling to give informed consent
  • Prior androgen suppression therapy
  • Current or past chemotherapy for prostate cancer
  • Previous prostate surgery including HIFU, TUNA, RITA, microwave, cryotherapy, or any curative treatment
  • Prior radiation therapy to prostate or pelvis
  • Any illness or history that may affect study results or increase risk (e.g., significant cardiovascular disease, allergies)
  • History of non-compliance with medical therapy or recommendations
  • Unable or unwilling to complete self-assessment questionnaires
  • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter issues, or symptoms preventing normal urination
  • Participation in another clinical study or investigational treatment within the past 90 days
  • Contraindications to MRI such as pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, or allergy to MRI contrast agents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

K

Kateri Corr

CONTACT

S

Sangeet Ghai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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