Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INTURO0110
Study information
Scientific title
Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis: A prospective multicentre study
Acronym
Study hypothesis
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
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)
Study design
Prospective multicentre observational study
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/11/2009
Overall trial end date
30/10/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Male
Target number of participants
1000
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
30/10/2011
Locations
Countries of recruitment
Italy
Trial participating centre
UOC Urologia
Napoli
80100
Italy
Sponsor information
Organisation
National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
Sponsor details
Via M Semmola
Napoli
80100
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary