Focal therapy of recurrent prostate cancer after external beam radiation therapy using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology (FOXPRO_RAD) – an initial pilot study

Focal therapy of recurrent prostate cancer after external beam radiation therapy using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology (FOXPRO_RAD) – an initial pilot study - FOXPRO_RAD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009020

Enrollment

Registered

2015-10-12

Start date

2015-10-19

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

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Previous external beam radiation therapy of prostate cancer -Serum PSA: PSA = 10 ng/ml - mpMRT/TRUS bioptic proven recurrent prostate cancer radiation therapy: - Clinical stage: localized, unifocal - Gleason score = 4 + 3 - Life expectancy > 10 yr

Exclusion criteria

Exclusion criteria: urinary tract infection; metastases of prostate cancer

Design outcomes

Primary

Measure	Time frame
Proportion of patients without residual tumor in the treated areal - Focal ablation of prostate cancer with negative mpMRI/TRUS fused biopsy at 12 mo after treatment	—

Secondary

Measure	Time frame
Secondary treatment free time (5 years) Biochemical treatment failure (lifelong) Metastatic-free survival (lifelong) Cancer-specific mortality (lifelong) Overall mortality (lifelong) Functional outcome (3 years) Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRI/TRUS-guided prostate biopsy (12 months) Assessment of safety: 60-day postoperative complications using Clavien-Dingo grading system	—

Measure

Time frame

Secondary treatment free time (5 years) Biochemical treatment failure (lifelong) Metastatic-free survival (lifelong) Cancer-specific mortality (lifelong) Overall mortality (lifelong) Functional outcome (3 years) Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRI/TRUS-guided prostate biopsy (12 months) Assessment of safety: 60-day postoperative complications using Clavien-Dingo grading system

—

Countries

Germany

Contacts

Public ContactJost von Hardenberg

Universitätsmedizin Mannheim, Klinik für Urologie

jost.vonhardenberg@medma.uni-heidelberg.de06213832215

Outcome results

None listed

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