Prostate MRI imaging study
| ISRCTN | ISRCTN16082556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16082556 |
| ClinicalTrials.gov number | NCT01292291 |
| Secondary identifying numbers | PROMIS PR11; HTA 09/22/67 |
- Submission date
- 07/12/2011
- Registration date
- 09/12/2011
- Last edited
- 24/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Mark Emberton
Scientific
Scientific
MRC Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| MRCCTU.PROMIS@ucl.ac.uk |
Study information
| Study design | Prospective validating paired cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | PROstate MRI Imaging Study (PROMIS): evaluation of multi-parametric magnetic imaging in the diagnosis and characterisation of prostate cancer |
| Study acronym | PROMIS |
| Study objectives | 1. In men identified with clinical suspicion of prostate cancer, those with favourable MP-MRI results could safely avoid unnecessary biopsy 2. An MP-MRI based pathway can improve the rate of detection of clinically significant cancer as compared to TRUS biopsy 3. An MP-MRI based diagnostic pathway can be cost-effective More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/092267/#/ |
| Ethics approval(s) | North West London Research Ethics Committee, 16/03/2011, ref: 11/LO/0185 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | All patients will receive the same treatment - Multi-parametric MRI scan and the combined prostate biopsy procedure (Template Prostate Mapping biopsy [TPM], followed by Trans Rectal Ultrasound Biopsy [TRUS]). |
| Intervention type | Other |
| Primary outcome measure | 1. Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values 2. Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values [an overall MP-MRI score will be given from 1-5 (definite benign 1, probably benign 2, indeterminate 3, probably malignant 4, definitely malignant 5), where the primary definition of a positive result is MP-MRI score of ≥3] 3. Primary definition of cancer according to biopsy: Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 6 mm |
| Secondary outcome measures | 1. Evaluation of MRI according to secondary definition of prostate cancer (Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 4 mm) 2. Evaluation of the optimal combination of MP-MRI parameters (T2, DW, DCE) 3. Cost-effectiveness 4. Inter-observer variation in the reporting of MP-MRI 5. Evaluation of factors associated with detection of clinically significant prostate cancer 6. Outcomes associated with translational work |
| Overall study start date | 28/03/2012 |
| Completion date | 28/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 714 |
| Key inclusion criteria | 1. Are aged 18 years or over, are at risk of prostate cancer and have been advised to have a prostate biopsy 2. Have a serum prostate-specific antigen (PSA) value of less than or equal 15ng/ml in the last 3 months 3. Have suspected less than or equal T2 on rectal examination 4. Are fit for general/spinal anaesthesia and all study procedures |
| Key exclusion criteria | Current exclusion criteria as of 22/05/2012: 1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months 2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer 3. Have urinary tract infection or history of acute prostatitis within the last 3 months 4. Have a contraindication to MRI or any other medical condition precluding study procedures 5. Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work. Previous exclusion criteria: 1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months 2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer 3. Have urinary tract infection or history of acute prostatitis within the last 3 months 4. Have a contraindication to MRI or any other medical condition precluding study procedures 5. Have previous history of hip replacement surgery |
| Date of first enrolment | 28/03/2012 |
| Date of final enrolment | 28/04/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit at UCL
London
WC2B 6NH
United Kingdom
WC2B 6NH
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
c/o Professor Mark Emberton
Division of Surgery and Interventional Sciences
67 Riding House Street
London
W1P 7NN
England
United Kingdom
| m.emberton@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2015 | Yes | No | |
| Results article | results | 25/02/2017 | Yes | No | |
| Results article | results | 01/07/2018 | Yes | No | |
| Plain English results | 24/03/2022 | No | Yes |
Editorial Notes
24/03/2022: Plain English results added.
25/07/2018: Publication references added.
20/01/2017: Publication references added.
22/05/2012: The following changes were made to the trial record:
1. The overall start date was changed from 30/01/2012 to 28/03/2012.
2. The overall trial end date was changed from 30/01/2016 to 28/04/2015.
