Focal therapy of localized prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology

Focal therapy of localized prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology - FOXPRO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007105

Enrollment

Registered

2014-11-04

Start date

2014-11-05

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: - Treatment of prostate cancer lesion using multiparametricMRI/ transrectal-ultrasound(TRUS)-guided HIFU (device: FocalOne®, EDAP TMS GmbH, France) - 12 months post-therapy control biopsy of

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Serum PSA: PSA 10 yr

Exclusion criteria

Exclusion criteria: Previous treatment: Previous treatment of the primary cancer within the prostate Previous hormone treatment for prostate cancer within 6 months before trial Previous radiation to pelvis Active urinary tract infection One or more of the following findings in multiparametric MRI: PI-RADS score 3 of opposite site Extracapsular extension or seminal vesicle invasion

Design outcomes

Primary

Measure	Time frame
Focal ablation of prostate cancer lesion with negative mpMRI/TRUS fused biopsy at 12 mo after treatment	—

Secondary

Measure	Time frame
- 5-year secondary treatment free time - Biochemical treatment failure - Metastatic-free survival - Cancer-specific mortality - Overall mortality - Functional outcome (incontinence voiding, erectile dysfunction, quality of life, anxiety) - Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRT/TRUS-guided prostate biopsy - 5-year costs of treatment - 60-day postoperative complications using Clavien-Dingo grading system	—

Measure

Time frame

- 5-year secondary treatment free time - Biochemical treatment failure - Metastatic-free survival - Cancer-specific mortality - Overall mortality - Functional outcome (incontinence voiding, erectile dysfunction, quality of life, anxiety) - Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRT/TRUS-guided prostate biopsy - 5-year costs of treatment - 60-day postoperative complications using Clavien-Dingo grading system

—

Countries

Germany

Contacts

Public ContactNiklas Westhoff

Universitätsmedizin Mannheim, Klinik für Urologie

niklas.westhoff@medma.uni-heidelberg.de06213832215

Outcome results

None listed

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