Unique ID issued by UMIN | UMIN000016934 |
---|---|
Receipt number | R000019660 |
Scientific Title | Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. |
Date of disclosure of the study information | 2015/03/27 |
Last modified on | 2018/06/07 15:13:57 |
Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. (PROPHET).
Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. (PROPHET).
Japan |
Prostate cancer
Urology | Laboratory medicine |
Malignancy
NO
Cancer diagnostic accuracy of [-2]proPSA-related indices, which are secondary markers of prostate specific antigen (PSA) as a standard diagnostic marker of prostate cancer, are compared with free-PSA/total PSA (%f-PSA) as a present secondary marker for cancer diagnosis. In addition, to investigate the correlation between pathological findings (Gleason score, biopsy positive rate) and [-2]proPSA-related indices, the comparison of diagnostic accuracy between [-2]proPSA-related indices and %f-PSA, the comparison of diagnostic accuracy of prostate volume- or transition zone volume-adjusted PSA-related index (PSA density) with that of [-2]proPSA-related indices, diagnostic signifivance of prostate volume-adjusted [-2] proPSA-related indices, and comparison of diagnostic accuracy and cost effectiveness between MRI and [-2]proPSA-related indices.
Others
Cancer diagnostic accuracy of [-2] proPSA-related indices.
Cancer diagnostic accuracy (area under receiver operating characteristic (ROC) curve, sensitivity, specificity, positive predictive value, negative predictive value) of [-2] proPSA-related indices.
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 ).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment | Other |
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 -70 degree Celsius after informed consent.
2) Digital rectal examination (DRE) and transrectal ultrasonography (TRUS) are performed, and total prostate volume and transition zone volume are measured after informed consent and taking blood samples and before the prostate biopsy. In addition, optional MRI is performed by physician's judgment.
50 | years-old | <= |
79 | years-old | >= |
Male
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.
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.
300
1st name | |
Middle name | |
Last name | Kazuhiro Suzuki |
Gunma University Graduate School of Medicine
Department of Urology
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
027-220-8301
kazu@gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuto Ito |
Gunma University Graduate School of Medicine
Department of Urology
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
027-220-8301
kzito@gunma-u.ac.jp
Clinical Research Support Center Kyushu
Beckman Coulter Japan
Profit organization
Japan
NO
群馬大学病院(群馬県)、獨協医科大学越谷病院(埼玉県)、JCHO東京新宿メディカルセンター(東京都)、横浜市立大学病院(神奈川県)、横浜市立市民病院(神奈川県)、香川大学病院(香川県)、九州大学病院(福岡県)、長崎大学病院(長崎県)
2015 | Year | 03 | Month | 27 | Day |
Unpublished
Main results already published
2015 | Year | 03 | Month | 25 | Day |
2015 | Year | 04 | Month | 20 | Day |
2017 | Year | 06 | Month | 30 | Day |
2015 | Year | 03 | Month | 27 | Day |
2018 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019660