Clinical trial · Observational
All-in-One Prostate Cancer Staging with MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prior to treatment, it is essential to assess not only the extent of prostate cancer within the prostate, but also to determine whether the disease has initiated metastatic spread. Whole-body MRI has become a viable option for the detection of metastatic disease derived from a number of cancers, but is typically performed in a separate scanning session to an initial dedicated prostate MRI in which the local disease is assessed. In patients known to be at high risk for significant prostate cancer prior to this initial MRI, and thus highly likely to proceed to treatment, this delays arriving at a definitive treatment decision. The investigators will evaluate the sensitivity of a protocol that combines bi-parametric prostate MRI, performed according to PI-RADS v2.1 guidelines, with a whole-body MRI based on the METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) guidelines, for an All-in-One, local and systemic staging of intermediate-favorable or high risk prostate cancer patients. The resulting staging decisions will be compared to the results of systemic staging with those obtained by computed tomography and bone scintigraphy in the standard staging pathway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate Cancer Patients | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate Cancer Patients
- description
- Patients will undergo a combined whole-body MRI + multiparametric prostate MRI examination along with routine staging examinations (PET, CT / bone scintigraphy). Reporting will be performed without and with reference to the whole-body MRI examination. Differences in the resulting staging and in management recommendations based on the two reportings will be recorded.
- interventionNames
- Diagnostic Test: Prostate Cancer Patients
Primary outcomes (1)
- measure
- Staging Sensitivity
- timeFrame
- 1 year
- description
- Sensitivity (SE) of the evaluated diagnostic procedures based on the case report forms (CRFs) compiled at the time of reporting
Secondary outcomes (1)
- measure
- Staging Specificity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * at least one of: International Society of Urological Pathology Grade Group ≥ 3 (Gleason Score ≥ 4+3); cT3 initial diagnosis with any PSA level; PSA ≥ 20 ng/mL with any Gleason score; * and all the following: Signed informed consent; Patients eligible to active treatment (either radical prostatectomy or radiotherapy) and/or hormone therapy; Life expectancy ≥ 10 years; Exclusion Criteria: * Contraindications to MRI (e.g. severe claustrophobia or MRI unsafe device); * Previous or ongoing hormone therapy or radiation therapy for prostate cancer; * Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols; * Previous mp-MRI performed within six weeks of the outpatient visit and compliant with PI-RADS v2.1 guidelines; * Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components;
References
Publications (20)
- BACKGROUNDBjurlin MA, Rosenkrantz AB, Beltran LS, Raad RA, Taneja SS. Imaging and evaluation of patients with high-risk prostate cancer. Nat Rev Urol. 2015 Nov;12(11):617-28. doi: 10.1038/nrurol.2015.242. Epub 2015 Oct 20. PMID 26481576
- BACKGROUNDTurkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18. PMID 30898406
- BACKGROUNDPasoglou V, Larbi A, Collette L, Annet L, Jamar F, Machiels JP, Michoux N, Vande Berg BC, Tombal B, Lecouvet FE. One-step TNM staging of high-risk prostate cancer using magnetic resonance imaging (MRI): toward an upfront simplified "all-in-one" imaging approach? Prostate. 2014 May;74(5):469-77. doi: 10.1002/pros.22764. Epub 2013 Dec 24. PMID 24375774
- BACKGROUNDMorote J, Celma A, Roche S, de Torres IM, Mast R, Semedey ME, Regis L, Planas J. Who Benefits from Multiparametric Magnetic Resonance Imaging After Suspicion of Prostate Cancer? Eur Urol Oncol. 2019 Nov;2(6):664-669. doi: 10.1016/j.euo.2018.11.009. Epub 2018 Dec 14. PMID 31411977
- BACKGROUNDWoo S, Suh CH, Kim SY, Cho JY, Kim SH, Moon MH. Head-to-Head Comparison Between Biparametric and Multiparametric MRI for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2018 Nov;211(5):W226-W241. doi: 10.2214/AJR.18.19880. Epub 2018 Sep 21. PMID 30240296
- BACKGROUNDChoi MH, Kim CK, Lee YJ, Jung SE. Prebiopsy Biparametric MRI for Clinically Significant Prostate Cancer Detection With PI-RADS Version 2: A Multicenter Study. AJR Am J Roentgenol. 2019 Apr;212(4):839-846. doi: 10.2214/AJR.18.20498. Epub 2019 Feb 19. PMID 30779662