Clinical trial · Interventional
MRI in Diagnosing Prostate Cancer
PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
NCT01292291CI-TRIAL-00011655unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease. PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.
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 (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biologic sample preservation procedure | Other | — | UNRESOLVED |
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| multiparametric magnetic resonance imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| study of socioeconomic and demographic variables | Other | — | UNRESOLVED |
| transperineal prostate biopsy | Procedure |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Safety of multiparametric magnetic resonance imaging (MP-MRI)
- measure
- Recruitment
- measure
- Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
- measure
- Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values
Secondary outcomes (9)
- measure
- Proportion of men who could safely avoid biopsy
- measure
- Proportion of men testing positive on MP-MRI
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Men at risk of prostate cancer who have been advised to have a prostate biopsy * Suspected stage ≤ T2 on rectal examination (organ confined) * Serum PSA ≤ 15 ng/mL within the past 3 months PATIENT CHARACTERISTICS: * Fit for general/spinal anesthesia * Fit to undergo all protocol procedures including a transrectal ultrasound * No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months * No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50) * No other medical condition precluding procedures described in the protocol PRIOR CONCURRENT THERAPY: * No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable) * No prior hip replacement surgery
References
Publications (3)
- DERIVEDStavrinides V, Norris JM, Karapanagiotis S, Giganti F, Grey A, Trahearn N, Freeman A, Haider A, Carmona Echeverria LM, Bott SRJ, Brown LC, Burns-Cox N, Dudderidge TJ, El-Shater Bosaily A, Ghei M, Henderson A, Hindley RG, Kaplan RS, Oldroyd R, Parker C, Persad R, Rosario DJ, Shergill IS, Winkler M, Kirkham A, Punwani S, Whitaker HC, Ahmed HU, Emberton M; PROMIS Group. Regional Histopathology and Prostate MRI Positivity: A Secondary Analysis of the PROMIS Trial. Radiology. 2023 Apr;307(1):e220762. doi: 10.1148/radiol.220762. Epub 2022 Dec 13. PMID 36511804
- DERIVEDBrown LC, Ahmed HU, Faria R, El-Shater Bosaily A, Gabe R, Kaplan RS, Parmar M, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham A, Oldroyd R, Parker C, Bott S, Burns-Cox N, Dudderidge T, Ghei M, Henderson A, Persad R, Rosario DJ, Shergill I, Winkler M, Soares M, Spackman E, Sculpher M, Emberton M. Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study. Health Technol Assess. 2018 Jul;22(39):1-176. doi: 10.3310/hta22390. PMID 30040065
- DERIVEDAhmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20. PMID 28110982