UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
Title of the study (Brief title)	Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. (PROPHET).
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Others
Basic objectives -Others	Cancer diagnostic accuracy of [-2] proPSA-related indices.
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment Other
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	79 years-old >=
Gender	Male
Key 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.
Key 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.
Target sample size	300

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL	027-220-8301
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	Kazuto Ito
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL	027-220-8301
Homepage URL
Email	kzito@gunma-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Beckman Coulter Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 03 Month 25 Day
Anticipated trial start date	2015 Year 04 Month 20 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 27 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019660