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 trial tests a procedure called Micro-Ultrasound Guided Focal Laser Ablation to determine if it can safely delay or eliminate the need for more invasive treatments, such as surgery or radiation, for men with intermediate-risk prostate cancer. Participants will receive this laser treatment and undergo follow-up assessments to evaluate its effectiveness. Men diagnosed with intermediate-risk prostate cancer, with cancer confined to one side of the prostate and no history of certain treatments, might be suitable candidates for this study. As an unphased trial, it offers participants the chance to explore innovative treatment options that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have received androgen suppression therapy or chemotherapy for prostate cancer.

What prior data suggests that Micro-Ultrasound Guided Focal Laser Ablation is safe for prostate cancer treatment?

Research has shown that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe and practical treatment for prostate cancer. Studies have found that patients generally handle this procedure well. One study found that only 18% of participants experienced a return of cancer within a year after treatment, suggesting its effectiveness. This treatment is minimally invasive, involving less cutting and often allowing for faster recovery.

The procedure has a low rate of complications, with serious side effects being uncommon. It uses a detailed ultrasound to accurately target cancerous tissue, reducing harm to nearby areas. While any medical procedure carries some risk, current findings support the safety of MicroUSgFLA for treating localized prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prostate cancer treatments like surgery, radiation, or hormone therapy, Micro-Ultrasound-Guided Focal Laser Ablation offers a minimally invasive approach. This technique uses precise laser technology guided by micro-ultrasound to target and destroy cancerous tissue without the need for major surgery. Researchers are excited about this method because it promises less recovery time, fewer side effects, and the potential to preserve healthy tissue, which can improve the quality of life for patients.

What evidence suggests that Micro-Ultrasound Guided Focal Laser Ablation is effective for prostate cancer?

Research shows that Micro-ultrasound-Guided Focal Laser Ablation, the treatment under study in this single-arm trial, offers a promising approach for prostate cancer. Studies have found it safe and practical, with cancer returning in 18% of patients one year after treatment. In some cases, cancer persisted in 4% to 57% of patients, but significant cancer appeared in only 0 to 31% of cases. This minimally invasive treatment involves less cutting and shorter recovery time, with a low rate of complications. Overall, it may effectively target and treat prostate cancer with fewer side effects than more invasive treatments. ^{1 2 4 5 6}

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07339943?cond=cancer

Micro-ultrasound-Guided Focal Laser Ablation for ...

If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community ...

2.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.233371

MRI-directed Micro-US–guided Transperineal Focal Laser ...

Multifiber micro-US–guided focal laser ablation in participants with localized prostate cancer was safe and feasible, with 18% recurrence at 1-year follow-up.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11940040/

Transperineal Focal Laser Ablation of the Prostate for Prostate ...

The postfocal presence of cancer rate ranged from 4% to 57%, while clinically significant cancer was detected in 0 up to 31% of cases. Secondary ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2211568425000725

Laser-focused ablative therapy for prostate cancer and ...

Focal Laser ablation is an effective, well-tolerated, minimally invasive treatment for prostate cancer, which offers short treatment time, low complication rate ...

5.

tcr.amegroups.org

tcr.amegroups.org/article/view/86259/html

A narrative clinical trials review in the realm of focal therapy for ...

The study also reported early oncological outcomes at 6 months, revealing clinically significant prostate cancer (Gleason GG 2 and above) in ...

6.

diagnosticimaging.com

diagnosticimaging.com/view/mri-micro-ultrasound-guidance-focal-laser-ablation-prostate-cancer-

Can MRI and Micro-Ultrasound Guidance Bolster Focal Laser ...

Micro-ultrasound with 29 MHz resolution successfully localized 91 percent of prostate cancer lesions, offering a threefold increase in ...