Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000016934
• Date of registration: 27/03/2015
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Support Center Kyushu
• Public title: Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
• Scientific title: 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).
• Date of first enrolment: 2015/04/20
• Target sample size: 300
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019660
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Kazuhiro Suzuki
• Affiliation: Gunma University Graduate School of Medicine Department of Urology

• Name: Kazuto Ito
• Affiliation: Gunma University Graduate School of Medicine Department of Urology

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: 50years-old
Age maximum: 79years-old
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate cancer

Intervention(s)

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.

Primary Outcome(s)

Cancer diagnostic accuracy (area under receiver operating characteristic (ROC) curve, sensitivity, specificity, positive predictive value, negative predictive value) of [-2] proPSA-related indices.

Secondary Outcome(s)

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 ).

Source(s) of Monetary Support

Beckman Coulter Japan

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 30/06/2017