Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU … (NCT03531099) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
France108 participantsStarted 2018-10-02
Plain-language summary
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.
The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.
Who can participate
Age range
50 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:
* Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
* Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score \> 14.
* Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
* Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
* If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
* If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
* A maximum tumor length\> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
* Gleason 6 score (risk group 1 of the D'Amico classification).
* Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
* PSA ≤ 15ng / ml.
* Patient affiliated with health insurance or beneficiary of an equivalent plan.
Exclusion Criteria:
* Contraindications to treatment with HIFU-F:
* Tumor not accessible.
* Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of th…
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.
1This trial is comparing focused HIFU to active surveillance rather than to surgery or radiation — does that mean my doctor thinks active surveillance is a reasonable option for my type of low-risk prostate cancer, and how does that affect whether this trial would even be relevant for me?
2Since this is a Phase 3 trial, there should be more safety and effectiveness data than earlier phases — what does my doctor know so far about how well HIFU performed compared to active surveillance in preventing the need for radical treatment, and are there any published interim results we can review together?
3The trial is no longer recruiting, so I can't enroll — but based on what's being measured here, which is how many patients eventually needed radical treatment like surgery or radiation, can my doctor explain what that outcome means for my own situation and how it might guide my treatment decision?
4HIFU is a localized, non-surgical approach — how does my doctor think it compares in terms of side effects and quality of life to just staying on active surveillance, especially for things like urinary or sexual function?
5Are there other completed or ongoing studies on focal HIFU for low-risk prostate cancer that my doctor could point me to, so we can look at the broader picture before deciding whether HIFU, active surveillance, or a more aggressive treatment is the right path for me?
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
1
patient proportion who needed to seek radical treatment