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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-20

Study Completion Date

2025-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FocalOne

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. This study is a non-interventional study. All the data will be collected from routine care. Data as indicated in the table below will be systematically recorded on the e-CRF to coincide with the scheduled follow-up visits at 3, 6 and 12 months.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No