FAST - Study Frozen section analysis assisted MRI-Target Biopsy for Prostate Cancer Diagnosis - a Prospective, Randomized Study

FAST - Study Frozen section analysis assisted MRI-Target Biopsy for Prostate Cancer Diagnosis - a Prospective, Randomized Study - FAST

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032422

Enrollment

316

Registered

2023-08-14

Start date

2022-10-02

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: Control group: Standard prostate biopsy (MRI-targeted biopsy plus systematic 12 core biopsy) Group 2: Intervention group: Frozen section analysis assisted MRI-targeted prostate biopsy

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing perineal or transrectal prostate MRI-targeted biopsy with a PIRADS =4 lesion in mpMRI (3 Tesla MRI)

Exclusion criteria

Exclusion criteria: - Hip-TEP (Total Endo Prothesis) - Low MRI Quality - Participation in another clinical study - Anal sphincter stenosis - Dual antiplatelet therapy - MRI lesion <5mm

Design outcomes

Primary

Measure	Time frame
Detection of clinical significant prostate cancer (ISUP =2)	—

Secondary

Measure	Time frame
Reported pain/discomfort, Complications, surgeon reported operabilitiy during radical prostatectomy	—

Countries

Germany

Contacts

Public ContactMatthias Jahnen

Klinik und Poliklinik für Urologie des Klinikums rechts der Isar

matthias.jahnen@tum.de+49 89 4140 2590

Outcome results

None listed

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