RecruitingNot Applicable

MRI Guided Focal Laser Ablation of Prostate Cancer

Canada102 participantsStarted 2018-03-29

Plain-language summary

This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.

Who can participate

Age range

40 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men 40-80 years of age * Histologically proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4;) * Prostate cancer clinical stage T1c and T2 * MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid TRUS device * Size of MR visible tumor \<20mm * Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy * Prostate specific antigen (PSA) level \<15 ng/mL * IPSS, ICIQ-UI-SF, IIEF complete prior to procedure * Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer. Exclusion Criteria: * Medically unfit for focal therapy of the prostate * Patients who are unwilling or unable to give informed consent; * Patients who have received androgen suppression therapy * Patients who have received or are receiving chemotherapy for prostate carcinoma; * Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment * Patients who have undergone radiation therapy for prostate cancer or to the pelvis * 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 noncompliance with medical therapy and/or medical recommendat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months after treatment completion

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

Timeframe: 24 months after treatment completion

Trial details

NCT IDNCT03650595

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Sangeet Ghai, MD

416-340-4800 sangeet.ghai@uhn.ca

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 6 months after treatment completion

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

Timeframe: 24 months after treatment completion