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High Intensity Focused Ultrasound in Prostate Cancer

StatusRecruiting
PhasePhase 2
Started2025-05-14
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
minor
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2025-06-12
minor
Study Status, Eligibility v5
Start dateestimated 2025-06→confirmed 2025-05-14
Eligibility criteria-126 characters
[...] on imaging Bilateral clinically significant prostate cancer (≥GG2 bilaterally) GG1 prostate cancer at relapse biopsy (this will not be considered clinically significant prostate cancer) Presence of brachytherapy seeds still implanted Presence of [...]
2025-05-05
minor
Study Status v4
Start date2025-04→2025-06
2025-03-04
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2025-02→2025-04
Eligibility criteria+275 characters
Inclusion Criteria: Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer Males who are ≥ 18 years of age Eastern Cooperative Oncology [...] A history of prostate cancer treated with radiation therapy or proton beam therapy +/- hormone therapy MRI or prostate-specific membrane antige [...] to the ROI PSMA PET negative for metastatic disease (within 36 months of the biopsy) Subjects must not have more than one [...] l not be considered clinically significant prostate cancer) HistoryPresence of brachytherapy seeds still implanted Presence or otherof fiduci [...] [...]
Study sitesdetails revised at 1 of 1 site
2024-12-11
minor
Study Status v2
Start date2024-11→2025-02
2024-09-11
minor
Study Identification, Study Status, Contacts/Locations v1
Start date2024-08→2024-11
Study sitescontacts updated at 1 of 1 site
2024-05-02
minor
Original filing
This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.
Trial Details
NCT Number NCT06402357
Lead Sponsor University of Florida
Collaborators: EDAP-TMS Focal One
Conditions Prostate Cancer
Enrollment 25 participants
Start Date 2025-05-14
Primary Completion 2027-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-08