What is Micro-Ultrasound Guided Focal Laser Ablation studying for intermediate-risk prostate cancer?

Micro-Ultrasound Guided Focal Laser Ablation is being studied to see if it can safely treat intermediate-risk prostate cancer and reduce or delay the need for surgery or radiation. The research evaluates how well this less invasive procedure works using micro-ultrasound guidance, aiming to offer a simpler treatment option for patients. The study is sponsored by the University Health Network, Toronto.

Who may be eligible for this intermediate-risk prostate cancer clinical trial?

Men between 40 and 80 years old with biopsy-confirmed intermediate-risk prostate cancer may be eligible. Participants must have a tumor visible on micro-ultrasound or MRI that is 15 mm or smaller and a PSA level under 15 ng/mL. Only men who can complete urinary and erectile function questionnaires are included. Please review eligibility criteria for more details.

Is there any cost to participate in this intermediate-risk prostate cancer clinical trial?

Study-related care, including the procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 85Years

MALE

ID07339943

Micro-Ultrasound Guided Focal Laser Ablation Treatment to Manage Intermediate-Risk Prostate Cancer Safety and Effectiveness Evaluation in Men Aged 40 to 85

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

Participants Needed

Research Sites

82 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Micro-Ultrasound Guided Focal Laser Ablation MicroUSgFLA as a treatment for men with intermediate-risk prostate cancer. This study aims to determine if this minimally invasive procedure can safely delay or avoid the need for more invasive treatments like surgery or radiation. The research focuses on men diagnosed with intermediate-risk prostate cancer to explore a simpler alternative to current options. Participants will receive MicroUSgFLA treatment using the TRANBERGCLS Thermal Therapy device, which targets cancerous areas in the prostate guided by micro-ultrasound imaging. This single-arm study involves treating patients and then assessing them through MRI scans, biopsies, and PSA blood tests at six months after treatment. The procedure is designed to be less complex than MRI-guided treatments and may be accessible in community settings. During the study, participants will complete questionnaires about urinary and erectile function before treatment. Follow-up assessments include monitoring PSA levels, imaging, and biopsies to evaluate the treatments technical success and impact on prostate cancer. The studys main outcomes are measured over six months, with safety and effectiveness closely monitored by the research team.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 85Years

MALE

Eligibility Criteria

You may qualify if you...

Men aged 40 to 80 years
Histologically confirmed intermediate-risk prostate cancer with Gleason score 7 and primary grade 3
Clinical stage T1c or T2 prostate cancer
MRI or MicroUS site suspicious for cancer or cancer localized to one prostate lobe
Maximum tumor size on MRI or MicroUS of 15 mm or less
Suspicious site on imaging must match sector positive for cancer on biopsy
Prostate specific antigen (PSA) level less than 15 ng/mL
Completion of IPSS, ICIQ-UI-SF, and IIEF-15 questionnaires before procedure
Life expectancy greater than 10 years based on non-prostate cancer co-morbidities

You will not qualify if you...

Tumor size on MRI or MicroUS greater than 15 mm
Medically unfit for focal prostate therapy
Unable or unwilling to give informed consent
Prior androgen suppression therapy
Previous or current chemotherapy for prostate cancer
Prior prostate surgery including HIFU, TUNA, RITA, microwave, cryotherapy, or other curative treatments
Prior radiation therapy to prostate or pelvis
Conditions or history that may affect study results or increase risks (e.g., significant cardiovascular conditions, 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 abnormalities, or any urinary symptoms preventing normal urination
Participation in another clinical study or investigational treatment within past 90 days
Contraindications to MRI such as pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, or allergy to MRI contrast agent

Research Team

Kateri Corr

Sangeet Ghai, MD

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