Focal therapy of prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology: a prospective register study (FOXPRO_REGISTER)

Focal therapy of prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology: a prospective register study (FOXPRO_REGISTER) - FOXPRO_REGISTER

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009021

Enrollment

Registered

2015-10-19

Start date

2015-09-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C61

Interventions

Group 1: - Focal ablation of prostate cancer lesion or lesions within the prostate using multiparametricMRI/ transrectal-ultrasound(TRUS)-guided HIFU (device: FocalOne®, EDAP TMS GmbH, France) after d

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - refusion of guideline conform prostate cancer therapy - serum PSA: PSA = 30 ng/ml - mpMRT/TRUS bioptic proven prostate cancer: Clinical stage: localized - No inclusion into trial FOXPRO or FOXPRO_RAD possible

Exclusion criteria

Exclusion criteria: acute urinary tract infection; lymph node or bone metastasis

Design outcomes

Primary

Measure	Time frame
Focal ablation of prostate cancer with negative mpMRI/TRUS fused biopsy at 12 mo after treatment* *in case of contraindications against a MRI: ultrasound-guided only	—

Secondary

Measure	Time frame
Secondary treatment free time Biochemical treatment failure Metastatic-free survival Cancer-specific mortality Overall mortality Functional outcome Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using control biopsy* *if no contraindications against a MRI Assessment of safety: 60-day postoperative complications using Clavien-Dingo grading system	—

Measure

Time frame

Secondary treatment free time Biochemical treatment failure Metastatic-free survival Cancer-specific mortality Overall mortality Functional outcome Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using control biopsy* *if no contraindications against a MRI Assessment of safety: 60-day postoperative complications using Clavien-Dingo grading system

—

Countries

Germany

Contacts

Public ContactJost;Manuel von Hardenberg;Ritter

Universitätsmedizin Mannheim, Klinik für Urologie;Klinik für Urologie, Universitätsmedizin Mannheim

jost.vonhardenberg@medma.uni-heidelberg.de;manuel.ritter@medma.uni-heidelberg.de06213832215;0621-3832215

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026