Prostate Cancer
Conditions
Brief 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.
Interventions
DEVICEFocalOne
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.
Sponsors
EDAP TMS S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of adverse events | 1 year | using the Clavien-Dindo classification |
| Evaluation of quality of life | 3, 6, 9 and 12 months | IQL questionnaires |
| Evaluation of urinary incontinence | 3, 6, 9 and 12 months | ICIQ questionnaire |
| Erectile function assessment | 3, 6, 9 and 12 months | IIEF-5 questionnaire |
| Urinary Symptoms | 3, 6, 9 and 12 months | IPSS questionnaire |
Countries
Spain
Outcome results
None listed