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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

Study acronym: HIFUSA
StatusActive, Not Recruiting
PhasePhase 3
Started2018-10-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 2, 2025 → Oct 2, 2026
See other at-risk trials from Hospices Civils de Lyon

Amendment history

2026-08-03
Study Status v13
Primary completion pushed: 2025-10-02 → 2026-10-02
2025-06-17
Study Status v12
Re-verified, no change to tracked fields
2024-02-27
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-10-02→2025-10-02
Enrollment targetestimated 146→confirmed 108
Study sites15→14
2021-11-19
Study Status v10
Primary completion date2025-10-02→2026-10-02
Completion date2025-10-02→2026-10-02
2021-01-13
Study Status, Eligibility, Contacts/Locations v9
Primary completion date2024-10-02→2025-10-02
Completion date2024-10-02→2025-10-02
Study sites14→15
Eligibility criteria+71 characters
[...] ate cancer (T1c or T2a) with the following characteristics: VisibleOnly one Target tumor on MRI: on a multiparametricmaximum MRIof showing2 acontigous singlesextants. Case invasiveallowed: If more than one target tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspectedon MRI foci may be included if, only one of thesethem focimust isbe 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 biopsi [...] [...]
Show 8 earlier versions
2019-09-16
Study Status v8
Primary completion date2023-10-02→2024-10-02
Completion date2023-10-02→2024-10-02
2019-06-12
Study Status, Contacts/Locations v7
Study sites11→14
2019-03-25
Study Status, Eligibility, Contacts/Locations v6
Eligibility criteria-97 characters
[...] s. Patients between the ages of 75 and 80 will need to have a lower G8 score > 14. Initial diagnosis of localized prostate cancer (T1T1c or T2a) with the following characteristics: AVisible tumor on MRI: a multiparametric MRI showing a single invasive tumor focus a [...] f only one of these foci is confirmed by targeted biopsies. The tumor volume on MRI should be> 0.5 cc, ie a tumor ≥10 mm in its longest dimension. A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (12 randomized biopsies and/or 2targeted biopsies per MRI target guided by fusion software). Gleason [...] [...]
Study sitesdetails revised at 2 of 11 sites
2019-01-21
Study Identification, Study Status, Contacts/Locations v5
Study sitesdetails revised at 2 of 11 sites
2018-12-06
Study Status, Eligibility, Contacts/Locations v4
Study sites10→11
Eligibility criteriarevised
[...] IFU-F treatment in prostate tissue around the target. PSA ≤ 10ng15ng / ml. Patient affiliated with health insurance or beneficia [...]
2018-10-02
Study Status v3
Primary completion date2023-07-01→2023-10-02
Completion date2023-07-01→2023-10-02
Start dateestimated 2018-09-18→confirmed 2018-10-02
2018-09-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2018-07-01→2018-09-18
Study sitesdetails revised at 10 of 10 sites
2018-07-06
Study Status, Oversight v1
Re-verified, no change to tracked fields
2018-05-09
Original filing
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.
Trial Details
NCT Number NCT03531099
Lead Sponsor Hospices Civils de Lyon
Conditions Prostate Cancer
Enrollment 108 participants
Start Date 2018-10-02
Primary Completion 2026-10-02 (estimated)
Study Completion 2026-10-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-04