UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI
Acronym	Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI (PROPHET-MRI).
Scientific Title	Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI
Scientific Title:Acronym	Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI (PROPHET-MRI).
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The comparison of diagnostic accuracy between [-2]proPSA-related indices and PI-RADS, which was evaluated by MRI before prostate biopsy, by using the registered data in PROPHET.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of diagnostic accuracy (area under ROC curve, sensitivity, specificity, positive predictive value, negative predictive value) between [-2] proPSA-related indices and MRI.
Key secondary outcomes	1) Risk for missing clinical significant prostate cancer in MRI-negative cases, and supplemental performance of [-2] proPSA-related indices. 2) Risk for missing clinical significant prostate cancer in cases under cutoff values of [-2] proPSA-related indices, and supplemental performance of MRI.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 enrolled in PROPHET 2) Patients who underwent MRI before prostate biopsy
Key exclusion criteria	1) Patients who are intent to withdraw from the study until the date of predefined deadline
Target sample size	109

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Suzuki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Zip code	3718511
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	1st name Kazuro Middle name Last name Ito
Organization	Kurosawa Hospital
Division name	Department of Urology
Zip code	370-1203
Address	187, Yanaka-machi, Takasaki, Gunma
TEL	027-352-1166
Homepage URL
Email	kzito@gunma-u.ac.jp

Sponsor
Institute	Department of Urology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Institute for Preventive Medicine, Kurosawa Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Dokkyo Medical University Saitama Medical Center Japan Community Health care Organization Tokyo Shinjuku Medical Center Yokohama City University, Graduate School of Medicine Kagawa University, Faculty of Medicine Kyushu University Hospital Nagasaki University Graduate School of Biomedical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Gunma University Hospital
Address	3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
Tel	027-220-7111
Email	eguchi@jimu.gunma-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	109
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 26 Day
Date of IRB	2022 Year 01 Month 27 Day
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This additional study is expected to decrease the numbers of unnecessary prostate biopsy by comparing diagnostic accuracy between MRI and [-2]proPSA-related indices.

Management information
Registered date	2022 Year 03 Month 16 Day
Last modified on	2022 Year 03 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053825