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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months, 12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months, 12 months, 24 months for reporting.

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 more
Other 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)

Find a Location

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.
~7 spots leftby Mar 2025