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ISRCTN
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ISRCTN31825442
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ClinicalTrials.gov identifier
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Public title
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Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis
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Scientific title
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Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis: A prospective multicentre study
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Acronym
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N/A
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Serial number at source
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INTURO0110
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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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)
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Study design
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Prospective multicentre observational study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2009
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Anticipated end date
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30/10/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
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Trial website
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Publications
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Contact name
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Dr
Sisto
Perdona
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Address
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UOC Urologia
INT Fondazione "G. Pascale"
Via M. Semmola
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City/town
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Napoli
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Zip/Postcode
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80100
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Country
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Italy
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Sponsor
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National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
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Address
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Via M Semmola
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City/town
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Napoli
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Zip/Postcode
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80100
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Country
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Italy
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Sponsor website:
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http://www.fondazionepascale.it
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Date applied
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18/02/2010
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Last edited
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10/03/2010
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Date ISRCTN assigned
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10/03/2010
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