Advanced imaging of prostate with 4-D ultrasound in suspected cases of prostate cancer: a randomised prospective study
| ISRCTN | ISRCTN39058446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39058446 |
| Secondary identifying numbers | N0024108495 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 23/10/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Mr Vinod Nargund
Scientific
Scientific
Department of Urology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 020 8510 7522 |
|---|---|
| vinod.nargund@homerton.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The use of real time 3-D (4-D ultrasound) guided transrectal biopsy of prostate improves sensitivity and specificity in identifying potential malignant foci in prostate gland compared to conventional 2-D ultrasonography. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Prostate |
| Intervention | 1.. 4-D ultrasound 2. Standard care July 2008: trial not started. |
| Intervention type | Other |
| Primary outcome measure | 1. Total PSA prostate volume 2. Volume of the tumour 3. PSA Density: PSA X volume 4. Histology of the cores: Gleason grading 5. Doppler findings: Pulsatility index, peak systolic volume, resistance index, flow velocity |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 31/01/2004 |
| Reason abandoned (if study stopped) | Not started because of lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Total 60 patients, 30 patients in 2-D group, 30 patients in 4-D group |
| Key inclusion criteria | 1. Patients with suspected carcinoma of the prostate, ie raised prostate specific antigen (PSA) 2. Age group 45-70 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Homerton University Hospital NHS Trust (UK)
No information available
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 |
