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MRI guided salvage-HIFU treatment in radiation-recurrent prostate cancer using the Focal One® technology

MRI guided salvage-HIFU treatment in radiation-recurrent prostate cancer using the Focal One® technology - MRI guided s-HIFU in recurrent prostate cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41038
Enrollment
50
Registered
2014-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent prostate cancer after EBRT

Interventions

Local treatment of recurrent prostate cancer with high intensity focal ultrasound using the Focal One® device (EDAP TMS).

Sponsors

Erasmus Universiteit Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Primary endpoints Main study parameter Local tumour control: Twelve month's after salvage HIFU treatment local tumour control will be evaluated by performing MRI and taking prostate biopsies.—

Secondary

MeasureTime frame
Biochemical and clinical progression: During 12 month*s PSA and health condition will be controlled and complaint related examinations such as bone scan or computer tomography (CT) will take place if necessary. Biochemical progression is defined as PSA nadir plus 2 (Phoenix criteria).—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)