Feasibility of focal treatment of localized prostate cancer with MRI / TRUS image fusion using the Focal One

Feasibility of focal treatment of localized prostate cancer with MRI / TRUS image fusion using the Focal One - PROFOCUS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007775

Enrollment

Registered

2016-04-11

Start date

2015-03-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

prostate cancer C61

Interventions

Group 1: Patients with unilateral prostate cancer who are eligible for an Active Surveillance after treatment and discharge from the hospital follow up examinations in the months 1, 3, 6, 12, 15, 18,

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Life expectancy> 10 years, PSA <= 15 ng / ml, clinically localized prostate cancer, the number of infested punching <= 30% of the extracted stamping cylinder, Gleason score <= 3 + 4 = 7, normal anal and rectal anatomy, maximum 2 in mpMRT visible lesions with PI-RADS score 4/5, rejection of also featured standard therapies, at least a visible lesion in mpMRT with a PI-RADS score 4/5, Accordance suspect mpMRT-areas with areas of positive punching

Exclusion criteria

Exclusion criteria: not limited clinical tumor stage, evidence of lymph node or distant metastases in the imaging, more than 2 visible MRI lesions with PI-RADS 4/5, no suspicious MRI lesion (PI RAS 4/5) with positive punch in the same sector, existing Urethralstenosen, unresolved coagulopathy, untreated urogenital infections, latex allergies, contraindications to MRI (pacemaker, metal prostheses o. ä.), participating in a treatment study for prostate within the last 30 days, missing capacity to consent, ongoing antihormonal therapy, TURP in the last 6 months

Design outcomes

Primary

Measure	Time frame
Bioptic tumor tissue of the treated areas within the MRI guided biopsy or MRI / TURS fusion biopsy after 6 month	—

Secondary

Measure	Time frame
all at inclusion and FU visits Months 3, 6, 18, 24: - Incontinence: changes in the ICS-male SF score - micturition: changes in IPSS score - Potency: changes in IIEF-5 score - Quality of life: EORTC QLQ C30, Version 3.0 - Anxiety and psychological stress: changes in HADS-Scale all at treatment and day of discharge and FU-months 1,3, 6, 12, 18, 24: - Safety: detection of adverse reactions to Clavien-Dindo	—

Measure

Time frame

all at inclusion and FU visits Months 3, 6, 18, 24: - Incontinence: changes in the ICS-male SF score - micturition: changes in IPSS score - Potency: changes in IIEF-5 score - Quality of life: EORTC QLQ C30, Version 3.0 - Anxiety and psychological stress: changes in HADS-Scale all at treatment and day of discharge and FU-months 1,3, 6, 12, 18, 24: - Safety: detection of adverse reactions to Clavien-Dindo

—

Countries

Germany

Contacts

Public ContactAlexander Fehr

Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie

alexander.fehr@med.ovgu.de0049-391-67-15039

Outcome results

None listed

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