Prostate Cancer Antigen 3 (PCA3) and functional Magnetic Resonance Imaging (MRI) in prostate cancer diagnosis

ISRCTN	ISRCTN31825442
DOI	https://doi.org/10.1186/ISRCTN31825442
Protocol serial number	INTURO0110
Sponsor	National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
Funder	National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)

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

UOC Urologia
INT Fondazione "G. Pascale"
Via M. Semmola
Napoli
80100
Italy

Study information

Primary study design	Observational
Study design	Prospective multicentre observational study
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	30/10/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan