Focal Laser Ablation for Prostate Cancer

(MicroUSgFLA Trial)

Overseen By Sangeet Ghai, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Androgen suppression, Chemotherapy

Disqualifiers: Prostate surgery, Radiation therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sangeet Ghai, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for men with intermediate-risk prostate cancer who might benefit from a less invasive treatment to delay or avoid radical surgery or radiation. Specific eligibility details are not provided, but typically participants should be in stable health and meet certain medical criteria.

Inclusion Criteria

My prostate cancer is in the early stages (T1c or T2).

I am a man aged between 40 and 80.

My prostate cancer has a Gleason score of 7 with a primary grade of 4 or less.

Exclusion Criteria

Maximum dimension of MRI/MicroUS visible tumour > 15 mm

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Micro-Ultrasound Guided Focal Laser Ablation for intermediate-risk prostate cancer

6 months

Multiple visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and biopsy assessments

6 months

Follow-up visits at 3 and 6 months

Long-term follow-up

Participants are monitored for long-term safety and effectiveness

Additional 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Micro-ultrasound-Guided Focal Laser Ablation

Trial Overview

The study is testing the safety and effectiveness of Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) over a 6-month period. It's a single-arm study, meaning all participants receive the TRANBERG|CLS Thermal therapy without comparison to another group.

How Is the Trial Designed?

Group I: Single-Arm Prospective Clinical Trial Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Exact Imaging

Industry Sponsor

Trials

6

Recruited

2,700+

Clinical Laserthermia Systems AB

Industry Sponsor

Trials

8

Recruited

150+