MRI guided salvage-HIFU treatment in radiation-recurrent prostate cancer using the Focal One® technology
Phase 2
Withdrawn
- Conditions
- recurrent prostate cancer after EBRT10038364
- Registration Number
- NL-OMON41038
- Lead Sponsor
- Erasmus Universiteit Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Inclusion criteria
Histologically proven recurrent prostate cancer any Gleason score History of EBRT
PSA * 20
iPSA * 30 (PSA before EBRT)
Maximum prostate height * 54 mm
WHO performance status < 2
Written informed consent
Exclusion Criteria
Anti-hormonal treatment within 12 month before study entry
Lymph node or bone metastasis (positive CT/bone scan or histologically proven) Low- or high-dose rate brachytherapy
Previous HIFU treatment
Inability to comply with the treatment protocol
Hip prosthesis, pacemaker / ICD (contraindication for MRI)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>Main study parameter<br /><br>Local tumour control: Twelve month's after salvage HIFU treatment local tumour<br /><br>control will be evaluated by performing MRI and taking prostate biopsies. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Biochemical and clinical progression: During 12 month*s PSA and health<br /><br>condition will be controlled and complaint related examinations such as bone<br /><br>scan or computer tomography (CT) will take place if necessary. Biochemical<br /><br>progression is defined as PSA nadir plus 2 (Phoenix criteria).</p><br>