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Procedure

High Intensity Focused Ultrasound for Prostate Cancer

Phase 2
Waitlist Available
Led By Tarik Benidir, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Contralateral grade group 1 (GG1) prostate cancer disease to the ROI
Males who are ≥ 18 years of age
Must not have
History of Urethral strictures
Bilateral clinically significant prostate cancer (≥GG2 bilaterally)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial will look at how well focused high intensity ultrasound works in treating prostate cancer that has come back after radiation therapy. It will also see how patients' quality of life changes after the ultrasound treatment."

Who is the study for?
This clinical trial is for individuals with localized prostate cancer that has come back after radiation therapy. Participants should be in good health otherwise and have a life expectancy of at least 10 years to see the long-term effects of the treatment.
What is being tested?
The study is testing a device called Focal One which uses high intensity focused ultrasound (HIFU) to treat areas in the prostate affected by cancer. It aims to evaluate how effective this treatment is and its impact on patients' quality of life.
What are the potential side effects?
Potential side effects may include discomfort or pain during or after the procedure, urinary issues such as difficulty urinating or urinary tract infections, erectile dysfunction, and rectal problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My other prostate side has low-grade cancer.
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I am a man aged 18 or older.
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I can care for myself but may not be able to do heavy physical work.
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I have been treated for prostate cancer with radiation or proton therapy, with or without hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had urethral strictures in the past.
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My prostate cancer is serious and affects both sides.
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My cancer has spread beyond its original location.
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My relapse biopsy shows I have GG1 prostate cancer.
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I have not had radiation therapy for prostate cancer.
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My scans show my cancer has grown beyond the original site.
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I have taken hormone therapy for my condition within the last 6 months.
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I have markers or seeds from previous treatments in the same area as my planned treatment.
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I have a large calcification that affects ultrasound treatment.
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I cannot have ultrasound due to allergies, no rectum, past fistula, or major rectal surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
In-field failure-free survival
Secondary study objectives
Change in quality of life metrics
Complication rates
Local failure-free survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: High Intensity Focused UltrasoundExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,401 Previous Clinical Trials
766,984 Total Patients Enrolled
11 Trials studying Prostate Cancer
3,848 Patients Enrolled for Prostate Cancer
EDAP-TMS Focal OneUNKNOWN
Tarik Benidir, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
147 Total Patients Enrolled
~17 spots leftby Aug 2027
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