MRI in Diagnosing Prostate Cancer
6. august 2013 opdateret af: University College London Hospitals
PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
- Andet: biologisk prøvekonserveringsprocedure
- Andet: laboratoriebiomarkøranalyse
- Procedure: diffusionsvægtet magnetisk resonansbilleddannelse
- Procedure: dynamisk kontrastforstærket magnetisk resonansbilleddannelse
- Procedure: livskvalitetsvurdering
- Andet: undersøgelse af socioøkonomiske og demografiske variabler
- Procedure: multiparametrisk magnetisk resonansbilleddannelse
- Procedure: transperineal prostata biopsi
- Procedure: transrektal prostatabiopsi
- Procedure: ultrasound-guided prostate biopsy
Detaljeret beskrivelse
OBJECTIVES:
- To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.
- To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.
- To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
714
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
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
|
Sekundære resultatmål
Resultatmål |
|---|
|
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)
|
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2011
Primær færdiggørelse (Forventet)
1. april 2013
Studieafslutning
7. december 2022
Datoer for studieregistrering
Først indsendt
8. februar 2011
Først indsendt, der opfyldte QC-kriterier
8. februar 2011
Først opslået (Skøn)
9. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. august 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2013
Sidst verificeret
1. september 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MRC-PR11
- CDR0000694647 (Registry Identifier: PDQ (Physician Data Query))
- EU-21104
- UCL-11/009
- ISRCTN16082556 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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