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

Recruiting
18 years of age
Male
Phase N/A

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Overview

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

Inclusion Criteria:

  • Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
  • Patient newly diagnosed with localized prostate cancer confirmed with an image guided 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 to provide informed written consent

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 complete Focal One user manual.

Study details

Prostate Cancer

NCT06375629

EDAP TMS S.A.

29 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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