The effect of magnetic resonance imaging localisation of prostate cancer on transrectal ultrasound biopsy detection rate
| ISRCTN | ISRCTN28276837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28276837 |
| Protocol serial number | N0436146607 |
| Sponsor | Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 05/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss S Jervis
Scientific
Scientific
Medical Physics
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 6495 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of magnetic resonance imaging localisation of prostate cancer on transrectal ultrasound biopsy detection rate |
| Study objectives | To investigate whether localisation information from magnetic resonance imaging (MRI) can be used to improve the accuracy of trans-rectal ultrasound (TRUS) biopsy and thereby improve the detection rate of prostate cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Randomised controlled trial |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage of patients with at least one positive biopsy in each cohort |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 122 |
| Key inclusion criteria | All patients who are to have a transrectal ultrasound (TRUS) biopsy (on a Thursday) to confirm prostate cancer, with an intermediate PSA level (10-19 ng/ml), will be eligible for entry to the study. On average 8 patients undergo TRUS biopsy at Cookridge Hospital per week (divided between Tuesday and Thursday morning sessions). One MRI slot per week (Thursday morning) will be available for the study. All consenting patients will be randomised and one selected for the MRI cohort and all others will form the non-MRI cohort. Assuming at least 2 patients are recruited a week (50%) recruitment rate) the two cohorts (61 patients in each) will be recruited in 61 weeks. |
| Key exclusion criteria | 1. Unwilling/unable to give informed consent 2. Significant claustrophobia 3. Contra indications to MRI: pacemaker, aneurysm clips, metallic foreign bodies in the eye |
| Date of first enrolment | 09/02/2004 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/02/2018: No publications found, verifying study status with principal investigator.
