NCT01292291

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
714

participants targeted

Target at P75+ for not_applicable prostate-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

February 8, 2011

Last Update Submit

August 6, 2013

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIA prostate cancerstage IIB prostate cancer

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

biologic sample preservation procedureOTHER
laboratory biomarker analysisOTHER
study of socioeconomic and demographic variablesOTHER
diffusion-weighted magnetic resonance imagingPROCEDURE
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE
multiparametric magnetic resonance imagingPROCEDURE
quality-of-life assessmentPROCEDURE
transperineal prostate biopsyPROCEDURE
transrectal prostate biopsyPROCEDURE
ultrasound-guided prostate biopsyPROCEDURE

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 36511804DERIVED

  • 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.

    PMID: 30040065DERIVED

  • 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.

    PMID: 28110982DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mark Emberton, MD, FRCS, MBBS

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Last Updated

August 7, 2013

Record last verified: 2011-09