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Cryotherapy
HIFU for Prostate Cancer
Phase 2 & 3
Waitlist Available
Led By Carey Robertson, MD
Research Sponsored by EDAP TMS S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of prostate cancer confirmed by PSA and prostate biopsy
Male subjects, aged equal to or over 50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months, 12 months, 24 months
Awards & highlights
Study Summary
The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.
Eligible Conditions
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 6 months, 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months, 12 months, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy
Secondary outcome measures
Achievement of a nadir PSA within 6 months < 0.5 ng/ml
Change from baseline in the International Prostate Symptom Score (IPSS)
Change from baseline in the University of California, Los Angeles Quality of Life (UCLA QOL)
+2 moreOther outcome measures
The occurrence of adverse events and device-related adverse events reported
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HIFUExperimental Treatment1 Intervention
Integrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device
Group II: CryotherapyActive Control1 Intervention
Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
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Who is running the clinical trial?
EDAP TMS S.A.Lead Sponsor
7 Previous Clinical Trials
389 Total Patients Enrolled
Carey Robertson, MDPrincipal InvestigatorDuke University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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