This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (\>= 3 ng/ml) and /or suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI/US fusion-guided biopsies (= TB with a maximum of 3 targets and 4 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with unsuspicious mpMRI will be receive follow-up according to current clinical standards. PRIMA will prospectively evaluate if stand-alone targeted MRI/US fusion-guided biopsy alone is sufficient to detect clinically significant prostate cancer (csPC with (ISUP grade group ≥ 2) and to avoid unnecessary detection of low-grade PC (ISUP 1) in biopsy-naïve men compared to a combined biopsy (systematic plus targeted) approach. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.
Men aged from 50 to 75 years
elevated PSA ≥ 3 ng/ml and/or cancer suspicious DRE
Men with known prostate cancer
men with prior prostate biopsy
men with non-MRI compatible devices
men with acute prostatitis
Parallel
PSA test
Diagnostic testtesting for blood levels of PSA
multiparametric prostate Magnetic Resonance Imaging (mpMRI)
DevicempMRI acquisition and reporting will be performed according to the current version of the Prostate Imaging-Reporting and Data System (PI-RADS). MpMRI will be performed at the different study centers on a 3 Tesla MR scanner using multi-phased array surface coil. MpMRI includes T1-weighted and T2-weighted imaging (T1WI, T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE-MRI). Hyoscine butyl bromide will be administered to optimize image quality. Prostate imaging quality will be assessed by the prostate imaging quality score (PI-QUAL). In case of contraindications to MRI contrast agents, DCE will be omitted. In case of contraindications to hyoscine butyl bromide, it will be omitted. Lesions with a PI-RADS score of ≥ 4 and 3 with PSAD \> 0.15 will considered suspicious for csPCa.
targeted MRI/US fusion-guided biopsy
Procedure/SurgeryTargeted MRI/US fusion-guided biopsy (TB) are performed using transrectal ultrasound (max. 4 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.
combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy)
Procedure/SurgeryThe combined biopsy comprises systematic biopsy (SB) and targeted MRI/US fusion-guided biopsy (TB). They are performed using transrectal ultrasound (number of cores: SB 12 cores, TB max. 4 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.
MRI inbore biopsy
Procedure/SurgeryMRI inbore biopsies will be offered after negative initial MRI/US fusion-guided biopsy or diagnosis of only clinically insignificant PCa in initial biopsy in arms A or B. Before performing MRI inbore biopsy the PI-RADS scoring will be re-confirmed. The number of cores will be 2 per target. In case of inaccurate needle position additional cores are allowed to ensure correct targeting. Needle position will be verified in 2 planes. Coverage with antibiotics has to be provided as per local standard of care.
detection rate of clinically significant and insignificant prostate cancers
The composite primary endpoint comprises non-inferiority in detecting clinically significant prostate cancer (ISUP grade group ≥ 2) and superiority in avoiding detection of clinically insignificant prostate cancer (ISUP grade group 1) of TB (arm A) compared to TB+SB (arm B)
Pain score (Visual Analogue Scale [VAS])
Patient Reported Outcomes (PROs) - diagnostic burden in arm A and B
Patient Reported Outcomes (PROs) - complications after biopsy
30-day complication-rate after biopsy in arm A and B
Patient Reported Outcomes (PROs) - quality of life according to EORTC-QLQ-C30
quality of life according to EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life of Cancer Patientes; Scoring according to manual) in all different study arms
Patient Reported Outcomes (PROs) - quality of life according to EPIC-26
quality of life according to EPIC-26 (Expanded prostate cancer index composite; Scoring according to manual) in all different study arms
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Heinrich-Heine University, Duesseldorf
Lead sponsor
University Hospital, Aachen
Collaborator
University Hospital, Bonn
Collaborator
University Hospital of Cologne
Collaborator
University Hospital, Essen
Collaborator
University Hospital Muenster
Collaborator
German Cancer Research Center
Collaborator
Marienhospital Herne
Collaborator
Städtische Kliniken Mönchengladbach
Collaborator
Evangelische Kliniken Essen-Mitte
Collaborator
Klinikum Dortmund
Collaborator
Stiftungsklinikum PROSELIS gGmbH Recklinghausen
Collaborator
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