Focal Laser Ablation for Prostate Cancer

(MRgFLA Trial)

Overseen By Kateri Corr, RPN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Androgen suppression, Chemotherapy

Disqualifiers: Surgery, Radiation, Cardiovascular, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Focal Laser Ablation to determine its effectiveness in managing early-stage prostate cancer. The goal is to treat the cancer with minimal side effects and help patients avoid more invasive procedures. MRI guidance accurately targets the cancerous area. Men with a confirmed diagnosis of low to intermediate-risk prostate cancer, where the tumor is small and confined to one area, might be suitable candidates for this study. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to less invasive treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on androgen suppression therapy or chemotherapy for prostate cancer, you would not be eligible to participate.

What prior data suggests that this focal laser ablation technique is safe for prostate cancer patients?

Research has shown that Focal Laser Ablation (FLA) is generally manageable for patients with prostate cancer. In past studies, most patients experienced only minor side effects, with no serious issues during the procedure. More than 80% of patients who underwent MRI-guided Focal Laser Ablation (MRgFLA) avoided more aggressive treatments and continued with Active Surveillance (AS) for about three years.

Other studies confirm that FLA is a safe and less invasive option for treating localized prostate cancer. However, it is important to note that FLA is still under development, so its long-term safety and effectiveness remain under investigation.

Overall, current evidence suggests that FLA is a promising and safe treatment for prostate cancer, with only minor side effects and no major risks reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focal laser ablation, like the TRANBERGCLS, is unique because it uses precise laser energy to target and destroy cancerous tissue in the prostate with minimal damage to surrounding areas. This method, guided by MRI, allows for a high degree of accuracy, which is a significant advancement compared to traditional treatments like surgery or radiation that can affect a larger area and have more side effects. Researchers are excited because this approach could offer a less invasive option with fewer side effects, potentially leading to quicker recovery and better quality of life for patients with low to intermediate-risk prostate cancer.

What evidence suggests that MRI guided Focal Laser Ablation is effective for prostate cancer?

Research has shown that focal laser ablation (FLA) is a promising treatment for prostate cancer. In one study, over 80% of patients with low to intermediate risk prostate cancer who received MRI-guided FLA avoided more invasive treatments for at least three years. Another study found that the treatment successfully targeted the cancer in all 10 patients tested. Patients experienced minimal side effects and no major complications. These findings suggest that FLA could be a safe and effective option for treating early-stage prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Sangeet Ghai, MD

Principal Investigator

Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging

Are You a Good Fit for This Trial?

This trial is for men aged 40-80 with early-stage prostate cancer (Gleason score ≤ 7, primary grade ≤ 4) who have a life expectancy of over 10 years. Eligible participants must have an MRI showing a suspicious site that matches the location of cancer found in biopsy, PSA level under 15 ng/mL, and cancer confined to one lobe of the prostate.

Inclusion Criteria

My MRI and biopsy results match for cancer location in the prostate.

My doctors expect me to live more than 10 years, not counting my prostate cancer.

Prostate specific antigen (PSA) level less than 15 ng/mL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRI guided Focal Laser Ablation (MRgFLA) for prostate cancer

1 day

1 visit (in-person)

Follow-up

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

24 months

MRI and biopsy at 6 months and 24 months, PSA assessments at regular intervals

What Are the Treatments Tested in This Trial?

Interventions

• The TRANBERGCLS

Trial Overview The study tests MRgFLA's effectiveness for treating low-intermediate risk prostate cancer. It involves using MRI guidance to apply targeted laser therapy directly to the tumor. Success will be measured by follow-up MRIs and biopsies.

How Is the Trial Designed?

Group I: Single arm prospective clinical trial Experimental Treatment 1 Intervention

This is a single arm study where patients with low-intermediate risk MR visible locally confined prostate cancer will be treated with focal laser ablation under MRI guidance in the magnet. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months and at 2 years, with PSA assessment at regular intervals during the time

The TRANBERGCLS is already approved in United States for the following indications:

Approved in United States as TRANBERG CLS for:

• Soft tissue ablation (not specifically approved for prostate cancer)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Clinical Laserthermia Systems AB

Industry Sponsor

Trials

8

Recruited

150+

Published Research Related to This Trial

Focal laser ablation is a safe and feasible treatment for intermediate risk prostate cancer, with no serious adverse events reported in a trial involving 8 men over 6 months.

While the treatment successfully reduced prostate-specific antigen levels in 7 out of 8 participants, follow-up biopsies indicated that larger treatment margins may be necessary for complete tumor ablation, as cancer was still detected outside the treated area in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. Natarajan, S., Raman, S., Priester, AM., et al.[2018]

Focal laser ablation for prostate cancer can be safely performed in a urology clinic using MRI-ultrasound fusion guidance, with 10 out of 11 patients successfully treated under local anesthesia and no significant adverse events reported.

At 6 months post-treatment, imaging and biopsies showed varying results in cancer presence, indicating that while the procedure is feasible, further research is needed to optimize treatment margins and assess long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Feasibility of Magnetic Resonance Imaging-Ultrasound Fusion for Guidance. Natarajan, S., Jones, TA., Priester, AM., et al.[2019]

Focal therapy for prostate cancer targets specific areas of the prostate with clinically significant disease, leading to reduced treatment-related side effects, although long-term cancer control is still being studied.

Focal laser ablation, which is compatible with real-time MRI, shows promise as a treatment option, supported by initial experiences with 23 patients and ongoing research into candidate selection and future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Lee, T., Mendhiratta, N., Sperling, D., et al.[2021]

Outpatient MRI-guided focal laser ablation was successfully performed on two patients with low-risk prostate cancer, demonstrating its feasibility as a treatment option.

The procedure effectively targeted the tumor with real-time monitoring of tissue temperature and confirmed devascularization post-treatment, with no adverse events reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance imaging-guided focal laser therapy in patients with low-risk prostate cancer. Raz, O., Haider, MA., Davidson, SR., et al.[2022]

In a study involving 25 men with early-stage prostate cancer, focal laser ablation (FLA) showed promising results, with 96% of biopsy sites showing no evidence of cancer three months post-treatment.

The procedure was safe, with no significant changes in urinary or sexual function reported, and an average decrease in prostate-specific antigen (PSA) levels of 44.2%, indicating effective early oncologic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications, Recovery, and Early Functional Outcomes and Oncologic Control Following In-bore Focal Laser Ablation of Prostate Cancer. Lepor, H., Llukani, E., Sperling, D., et al.[2015]

Focal therapy, specifically focal laser thermocoagulation, is a promising new treatment for prostate cancer that targets specific tumor regions, potentially leading to fewer side effects compared to traditional treatments.

This technique can be performed under real-time magnetic resonance imaging control, enhancing precision during the procedure, although long-term results are still needed to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Focal laser thermocoagulation for localized prostate cancer]. Glybochko, PV., Vinarov, AZ., Shpot, EV., et al.[2017]

In a phase II study involving 27 men with localized prostate cancer, 96% showed no evidence of cancer in the ablation zone at 3 months after undergoing magnetic resonance imaging guided focal laser ablation, indicating high short-term efficacy.

The procedure had an acceptable safety profile, with no significant changes in urinary symptoms and only a marginal decrease in sexual function at 1 and 3 months, suggesting that it may be a viable treatment option for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Evaluation of Magnetic Resonance Imaging Guided Focal Laser Ablation of Prostate Cancer. Eggener, SE., Yousuf, A., Watson, S., et al.[2018]

In a prospective phase II trial involving 44 men with intermediate-risk prostate cancer, MRI-guided focal therapy using high-intensity focused ultrasound was found to be safe, with no major treatment-related adverse events reported.

At the 5-month follow-up, 93% of participants were free of clinically significant prostate cancer at the treatment site, indicating promising early oncologic outcomes, while functional outcomes related to erectile function and urinary symptoms remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. Ghai, S., Finelli, A., Corr, K., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03634579

MRI Guided Prostate Cancer Focal Laser Ablation The study is a prospective, single-arm, non-randomized, unblinded trial to determine the safety and efficacy of MRI guided focal laser ablation of localized ...

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

Transperineal Focal Laser Ablation of the Prostate for Prostate ... Transperineal FLA for clinically localized prostate cancer appears to be a feasible and safe technique, offering oncological and functional outcomes

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3362007/

Focal Laser Ablation of Prostate Cancer - PubMed Central Image guided photothermal focal therapy for localized prostate cancer: phase I trial. Journal of Urology. 2009;182(4):1371–1377. doi: 10.1016/j.juro.2009.06 ...

4. inderes.dk inderes.dk/en/releases/cls-data-from-the-clinical-trial-using-mri-guided-fla-with-tranbergr-thermal-therapy-system-in-patients-with-prostate-cancer-at-radboud-university-medical-center-nijmegen-nl-is-now-published

CLS: Data from the clinical trial using MRI-guided FLA with ... In summary, technical success was achieved in 10 out of 10 patients with low to intermediate risk prostate cancer, and median tumor coverage was ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04045756

Study Details | NCT04045756 | Focal Laser Ablation for the ... The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary ...

6. mdpi.com mdpi.com/2072-6694/17/6/968

Transperineal Focal Laser Ablation of the Prostate for ... Conclusions: Transperineal FLA for the treatment of clinically localized prostate cancer appears to be a feasible, safe technique with an efficacy comparable to ...

7. researchgate.net researchgate.net/publication/235729923_MR_Imaging-guided_Focal_Laser_Ablation_for_Prostate_Cancer_Phase_I_Trial

MR Imaging–guided Focal Laser Ablation for Prostate ... Results: Treatment was successfully completed in nine patients (procedure duration, 2.5-4 hours; mean laser ablation duration, 4.3 minutes).

8. aetna.com aetna.com/cpb/medical/data/800_899/0843.html

Ablative Procedures for Prostate Cancer These researchers stated that early results for focal laser ablation of PCa are very encouraging; however, until long-term oncologic control is confirmed, focal ...