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Thermal Therapy

Focal Laser Ablation for Prostate Cancer (MRgFLA Trial)

N/A

Recruiting

Led By Sangeet Ghai, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy.

Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after treatment completion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method called MRI guided Focal Laser Ablation (MRgFLA) for treating early stage prostate cancer. The study will use repeated MRI scans and prostate biops

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Most patients previously treated with MRgFLA had minimal side effects without peri-operative complications. However, potential risks may include discomfort at the treatment site or changes in urinary or sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My prostate cancer is located in one lobe, confirmed by a special 3D ultrasound.

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

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I am a man aged between 40 and 80.

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My prostate cancer is low to intermediate risk with a Gleason score of 7 or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months after treatment completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months after treatment completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after treatment completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)

Secondary study objectives

Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm prospective clinical trialExperimental Treatment1 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

0 / 6Eligibility criteria met