Prostate cancer
Conditions
Interventions
1)All whole-blood samples (5mL for serum and plasma) are immediately stored at 4C after drawing from the patients, centrifuge and separate into serum and plasma samples within 3hr, and then store at
s judgment.
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients with suspicious findings on prostate cancer in the PSA value >=4.0ng/mL or more than age-specific PSA reference range (50-64years: 0.0-3.0ng/ml, 65-69years: 0.0-3.5ng/ml, >=70years: 0.0-4.0ng/ml) and =<10mg/mL 2) Patients who undergo an initial prostate biopsy within 3 months after informed consent (systematic biopsy: 12 - 20 cores. If required, additional target biopsy is acceptable .) 3) Men at 50 years or older and younger than 80 years. 4) Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with an apparent urinary tract infection. 2) Patients with an operation history of benign prostate hyperplasia. 3) Patients who are taking steroidal, non-steroidal anti-androgen, 5alpha-reductase inhibitor within 3 months. 4) Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer diagnostic accuracy (area under receiver operating characteristic (ROC) curve, sensitivity, specificity, positive predictive value, negative predictive value) of [-2] proPSA-related indices. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 ) Comparison of diagnostic accuracy (area under ROC curve, sensitivity, specificity, positive predictive value, negative predictive value) between of [-2] proPSA-related indices and %f-PSA. 2) Correlation of pathological findings (Gleason score, biopsy positive rate) with [-2]proPSA-related indices and %f-PSA. 3) Comparison of diagnostic accuracy (area under ROC curve, sensitivity, specificity, positive predictive value, negative predictive value) between prostate volume-adjusted PSA-related indices (PSAD, PSATZD) and [-2] proPSA-related indices 4) Diagnostic significance of prostate volume -adjusted [-2]proPSA-related indices, compared to that of %f-PSA and PSA density. 5) Comparison of diagnostic accuracy (area under ROC curve, sensitivity, specificity, positive predictive value, negative predictive value) between MRI and [-2]proPSA-related indices 6) Comparison of cost-effectiveness ratio (cost for one cancer diagnosis) introducing [-2] proPSA-related indices and prostate volume-adjusted [-2] proPSA-related indices to cancer diagnostic system (control: diagnostic system using PSA only, PSA+%f-PSA, PSA+MRI and PSA+%f-PSA+MRI ). | — |
Countries
Japan
Contacts
Public ContactKazuto Ito
Gunma University Graduate School of Medicine Department of Urology
Outcome results
None listed