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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000694647 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-21104 | |||
| UCL-11/009 | |||
| ISRCTN16082556 | Registry Identifier | ISRCTN (International Standard Randomised Controlled Trial Number Register) |
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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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.
Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.
Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.
After completion of study intervention, patients are followed up periodically.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biologic sample preservation procedure | Other | |||
| laboratory biomarker analysis | Other | |||
| study of socioeconomic and demographic variables | Other | |||
| diffusion-weighted magnetic resonance imaging | Procedure | |||
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | |||
| multiparametric magnetic resonance imaging | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of multiparametric magnetic resonance imaging (MP-MRI) | ||
| Recruitment | ||
| Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values | ||
| Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of men who could safely avoid biopsy | ||
| Proportion of men testing positive on MP-MRI | ||
| Performance characteristics of TRUS versus template prostate mapping (TPM) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Emberton, MD, FRCS, MBBS | University College London Hospitals | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36511804 | Derived | Stavrinides 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. | |
| 30040065 |
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| transperineal prostate biopsy | Procedure |
| transrectal prostate biopsy | Procedure |
| ultrasound-guided prostate biopsy | Procedure |
| Evaluation of the optimal combination of MP-MRI functional parameters |
| Intra-observer variability in the reporting of MP-MRI |
| Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer |
| Health-related quality of life using the EQ-5D questionnaire |
| Resource use and costs for further economic evaluation |
| Translational research |
| Derived |
| Brown 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. |
| 28110982 | Derived | Ahmed 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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