CompletedNot Applicable

Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

France, Guadeloupe3,862 participantsStarted 2015-03-23

Plain-language summary

to compare the efficacy of HIFU treatment with standard treatment in two situations: 1. as first-line cancer treatment, HIFU is compared to radical prostatectomy. 2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

Who can participate

Age range

70 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.

General inclusion criteria * Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0 * classified as low or intermediate risk * Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\]. * Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants * Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml * Patient affiliated with health insurance or beneficiary of an equivalent plan Inclusion criteria for the HIFU Arm * Patients 70 years of age or older * Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years Inclusion Criteria for Total Prostatectomy Arm • Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia. NON-INCLUSION CRITERIA * Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol * Included patient simultaneously participating in another research study

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

Recurrence-free survival

Timeframe: 30 months

Trial details

NCT IDNCT04307056

SponsorAssociation Francaise d'Urologie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-24

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