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.
Study Type
OBSERVATIONAL
Enrollment
14
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.
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo
Madrid, Spain
Hospital Universitario Central De Asturias
Oviedo, Spain
Hospital Universitario Marqués De Valdecilla
Santander, Spain
Evaluation of adverse events
using the Clavien-Dindo classification
Time frame: 1 year
Evaluation of quality of life
IQL questionnaires
Time frame: 3, 6, 9 and 12 months
Evaluation of urinary incontinence
ICIQ questionnaire
Time frame: 3, 6, 9 and 12 months
Erectile function assessment
IIEF-5 questionnaire
Time frame: 3, 6, 9 and 12 months
Urinary Symptoms
IPSS questionnaire
Time frame: 3, 6, 9 and 12 months
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Hospital Consorcio General Universitario de Valencia
Valencia, Spain