UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047187 |
|---|---|
| Receipt number | R000053825 |
| 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 |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2022/03/30 12:17:33 |
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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
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
kzito@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053825
