Journal Article

DKFZ-2026-00979

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png PRIMA: randomized prospective multicenter non-inferiority study for primary diagnosis of clinically significant PRostate cancer by PSA and MR IMAging-study protocol for a randomized diagnostic accuracy trial.

Al-Monajjed, R. (First author)DKFZ* ; Albers, P.DKFZ* ; Boschheidgen, M. ; Radtke, J. P.DKFZ* ; Droop, J. ; Benner, A.DKFZ* ; Hadaschik, B. ; Antoch, G. ; Schimmöller, L. ; Group, P. S. (Collaboration Author)

2026
BioMed Central London

Abstract: Diagnostic pathways based on PSA, digital rectal examination (DRE), and systematic biopsy (SB) may miss clinically significant prostate cancer (csPCa) and lead to overdiagnosis of indolent disease. Multiparametric MRI (mpMRI) and MRI-targeted biopsy (TB) improve detection of csPCa; however, the additional diagnostic value of routine SB in biopsy-naïve men with suspicious MRI findings remains controversial.PRIMA is a randomized, prospective, multicenter non-inferiority diagnostic accuracy trial in eight German hospitals. Biopsy-naïve men aged 50-75 years with PSA ≥ 3 ng/ml and/or suspicious DRE undergo mpMRI (PI-RADS v2.1, PI-QUAL v2). Men with PI-RADS 4-5 or PI-RADS 3 with PSA density > 0.15 are randomized 1:1 to TB only (Arm A) or TB + SB (Arm B). Persistent PI-RADS 4-5 lesions with negative biopsy undergo MRI in-bore biopsy.Co-primary endpoints are csPCa (ISUP ≥ 2) detection and detection of clinically insignificant cancer (ISUP 1). Secondary endpoints include patient-reported outcomes (EORTC-QLQ-C30, EPIC-26, VAS), biopsy-related complications, biopsy approach, MRI in-bore yield, AI/radiomics validation and follow-up cancer incidence.One thousand nine hundred eight men were allocated to achieve 1590 analyzable patients (> 80% power; non-inferiority margin δ = 13%).PRIMA will provide high-level evidence whether systematic biopsy can be safely omitted in MRI-positive biopsy-naïve men, potentially reducing diagnostic morbidity and overtreatment.ClinicalTrials.gov NCT04993508. Registered on 2 December 2022.

Keyword(s): Humans (MeSH) ; Male (MeSH) ; Prostatic Neoplasms: blood (MeSH) ; Prostatic Neoplasms: diagnostic imaging (MeSH) ; Prostatic Neoplasms: pathology (MeSH) ; Prostatic Neoplasms: diagnosis (MeSH) ; Prospective Studies (MeSH) ; Prostate-Specific Antigen: blood (MeSH) ; Multicenter Studies as Topic (MeSH) ; Aged (MeSH) ; Middle Aged (MeSH) ; Randomized Controlled Trials as Topic (MeSH) ; Equivalence Trials as Topic (MeSH) ; Image-Guided Biopsy: methods (MeSH) ; Magnetic Resonance Imaging (MeSH) ; Germany (MeSH) ; Predictive Value of Tests (MeSH) ; Multiparametric Magnetic Resonance Imaging (MeSH) ; Digital Rectal Examination (MeSH) ; Kallikreins: blood (MeSH) ; Diagnostic accuracy ; MpMRI ; PSA ; Prostate cancer ; Randomized trial ; Targeted biopsy ; Prostate-Specific Antigen ; Kallikreins ; KLK3 protein, human

Note: #EA:C130#

---

Contributing Institute(s):

1. Personalisierte Früherkennung des Prostatakarzinoms (C130)
2. E010 Radiologie (E010)
3. C060 Biostatistik (C060)

Research Program(s):

1. 313 - Krebsrisikofaktoren und Prävention (POF4-313) (POF4-313)

Appears in the scientific report 2026

---

Database coverage:
; ; ; Article Processing Charges ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; DOAJ Seal ; Ebsco Academic Search ; Essential Science Indicators ; Fees ; IF < 5 ; JCR ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

---