Condition category
Cancer
Date applied
18/02/2010
Date assigned
10/03/2010
Last edited
10/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sisto Perdona

ORCID ID

Contact details

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

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

http://www.fondazionepascale.it

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

Publication citations

Additional files

Editorial Notes