Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis
| ISRCTN | ISRCTN31825442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31825442 |
| Secondary identifying numbers | INTURO0110 |
- Submission date
- 18/02/2010
- Registration date
- 10/03/2010
- Last edited
- 10/03/2010
- 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
Dr Sisto Perdona
Scientific
Scientific
UOC Urologia
INT Fondazione "G. Pascale"
Via M. Semmola
Napoli
80100
Italy
Study information
| Study design | Prospective multicentre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis: A prospective multicentre study |
| Study objectives | By combining PCA3 testing and functional MRI imaging it is possible to improve sensitivity and specificity of current diagnostic tools in the management of patients at risk for prostate cancer. |
| Ethics approval(s) | The ethics committee of the National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) approved on the 29th of September 2009 (ref: DSC/2287) |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Visit 0 (baseline): screening for inclusion/exclusion criteria; informed consent; demographic data collection Visit 1 (within the 1st week): functional MRI Visit 2 (after 1 week): urine sample collection for PCA 3 assessment (Progensa PCA3™, Gen-probe Inc.); Prostate biopsy Visit 3 (at 1 month): registration of complications; discussion of biopsy outcome (if negative, follow up; if positive, clinical staging and treatment) Visit 4 (at 4 months): re-biopsy if indicated |
| Intervention type | Other |
| Primary outcome measure | 1. To estimate the diagnostic accuracy in terms of sensibility, sensitivity and predictive values of PCA3 2. To assess the diagnostic accuracy of morphologic and spectroscopic MRI in relation to PCA3 and biopsy outcomes |
| Secondary outcome measures | 1. To determine the best PCA3 cut-off score in terms of sensitivity and specificity 2. To correlate PCA3 to other known parameters (PSA, Gleason score, tumour stage) 3. To estimate the advantages of a new diagnostic algorithm in comparison with current standards on the basis of clinical and socio-economical parameters |
| Overall study start date | 01/11/2009 |
| Completion date | 30/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Age >45 yrs 2. Able to comply with the protocol procedures 3. Able to understand and give consent to the protocol procedures 4. Indication for prostate biopsy or re-biopsy based on clinical parameters and prostate-specific antigen (PSA) values |
| Key exclusion criteria | 1. PSA > 10 ng/ml 2. Therapy with finasteride or dutasteride in the previous 6 months 3. Unable to follow the protocol procedures and to give informed consent 4. Recent history of drug or alcohol abuse |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 30/10/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
UOC Urologia
Napoli
80100
Italy
80100
Italy
Sponsor information
National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
Research organisation
Research organisation
Via M Semmola
Napoli
80100
Italy
| Website | http://www.fondazionepascale.it |
|---|---|
"ROR" |
https://ror.org/05dwj7825 |
Funders
Funder type
Research organisation
National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
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 |
