UnknownNot Applicable

MRI-guided Focal Laser Ablation Prostate Cancer

Netherlands10 participantsStarted 2022-04-11

Plain-language summary

Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments. This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®\|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.

Who can participate

Age range

45 Years – 76 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: * MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); * maximum MRI visible lesion size is ≤ 20 mm large axis; * age 45 to 76 years old; * life expectancy at inclusion of more 10 years; * diagnosis of prostate cancer confirmed by targeted biopsy; * criteria of low and intermediate risk of progression and eligibility for focal therapy; * clinical stage of maximum T2c * maximum biopsy Gleason score of 4 + 3 on targeted biopsies * serum prostate specific antigen \< 15 ng/ml * patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice. Exclusion Criteria: * History of prostate surgery; * history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; * history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); * severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score \> 18; * tumor with extra-capsular extension or invasion of the seminal vesicles; * patients with \>2 lesions; * impossibility to obtain a valid informed consent; * patients unable to undergo MR imaging, including those with contra-indications; * contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); * metallic hip implant or any other metallic implant or device that distorts local magnetic …

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

completion of complete ablation without technical failures

Timeframe: 1 day

procedure-related adverse events and complications following SIR criteria

Timeframe: 6 months

Trial details

NCT IDNCT05370482

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-11

Contact for this trial

Yvonne Wimper

+31243611111 Yvonne.Wimper@radboudumc.nl

View on ClinicalTrials.gov More Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation trials