Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
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
Sponsors
National Cancer Institute (Istituto Nazionale Tumori [INT]) - G Pascale Foundation (Fondazione G. Pascale) (Italy)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed