ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer

Last updated: March 27, 2025
Sponsor: EDAP TMS S.A.
Overall Status: Terminated

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

FocalOne

Clinical Study ID

NCT06375629
EDAP TMS
  • Ages > 18
  • Male

Study Summary

The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient eligible for HIFU treatment for prostate cancer, excluding whole glandtreatment.

  • Patient newly diagnosed with localized prostate cancer confirmed with an imageguided biopsy (MRI and/or micro-ultrasounds).

  • Gleason ≤ 4+3.

  • Patient scheduled for HIFU treatment as determined by the physician.

  • Patient with healthcare coverage. Spanish-speaking patients with the ability toprovide informed written consent

Exclusion

Exclusion Criteria:

  • Patient with bilateral prostate cancer requiring whole gland treatment.

  • Patients clinically detected metastasis.

  • Patient with an extension of cancer or seminal vesicle invasion.

  • Patient with contraindications for HIFU treatment: please refer to the completeFocal One user manual.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: FocalOne
Phase:
Study Start date:
April 20, 2023
Estimated Completion Date:
March 14, 2025

Connect with a study center

  • Hospital Universitario Puerta del Mar

    Cadiz, 21 11009
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo

    Madrid, 46 28007
    Spain

    Site Not Available

  • Hospital Universitario Central De Asturias

    Oviedo, 33011
    Spain

    Site Not Available

  • Hospital Universitario Marqués De Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Consorcio General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

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