Prostate CancerNCT01292291
MRI in Diagnosing Prostate Cancer
A study testing biologic sample preservation procedure, laboratory biomarker analysis and study of socioeconomic and demographic variables in people with Prostate Cancer, run by University College London Hospitals.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biologic sample preservation procedure, laboratory biomarker analysis and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 714 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- biologic sample preservation procedure, laboratory biomarker analysis, study of socioeconomic and demographic variables, diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging
- Keywords
- stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
laboratory biomarker analysisOther
study of socioeconomic and demographic variablesOther
diffusion-weighted magnetic resonance imagingProcedure or surgery
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
multiparametric magnetic resonance imagingProcedure or surgery
quality-of-life assessmentProcedure or surgery
transperineal prostate biopsyProcedure or surgery
transrectal prostate biopsyProcedure or surgery
ultrasound-guided prostate biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Mark Emberton, MD, FRCS, MBBS, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292291
- Sponsor's protocol ID
- MRC-PR11
- Other IDs
- CDR0000694647, EU-21104, UCL-11/009, ISRCTN16082556
- Status last verified
- Sep 2011
- First submitted
- 8 Feb 2011
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
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.
PubMed 36511804Brown 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.
PubMed 30040065Ahmed 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.
PubMed 28110982
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01292291
- Acronym / sponsor ID
- MRC-PR11
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic sample preservation procedure | Other | – |
| laboratory biomarker analysis | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| diffusion-weighted magnetic resonance imaging | Procedure or surgery | – |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure or surgery | – |
| multiparametric magnetic resonance imaging | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| transperineal prostate biopsy | Procedure or surgery | – |
| transrectal prostate biopsy | Procedure or surgery | – |
| ultrasound-guided prostate biopsy | Procedure or surgery | – |
Primary outcome
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 36511804Stavrinides 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.
- Derived from this study: PubMed 30040065Brown 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.
- Derived from this study: PubMed 28110982Ahmed 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.
Related trials for Prostate Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Active, not recruitingPhase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer, Adenocarcinoma of the Prostate
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruiting
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Prostate, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Emberton, MD, FRCS, MBBS principal investigator
University College London Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing biologic sample preservation procedure, laboratory biomarker analysis and study of socioeconomic and demographic variables in people with Prostate Cancer, run by University College London Hospitals.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of multiparametric magnetic resonance imaging (MP-MRI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013; AzTrials last refreshed its copy on 31 Oct 2026.