UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055166 |
|---|---|
| Receipt number | R000063032 |
| Scientific Title | Evaluation of the Efficacy of the Risk Score (Pure Index) Using Urinary Spermine Measurements for Secondary Screening of Prostate Cancer: A Multicenter Study |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2025/08/13 12:10:31 |
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Basic information
Public title
Urine Test for Prostate Cancer Risk Assessment: A Multi-Center Study
Acronym
Urine Test for Prostate Cancer Risk Assessment
Scientific Title
Evaluation of the Efficacy of the Risk Score (Pure Index) Using Urinary Spermine Measurements for Secondary Screening of Prostate Cancer: A Multicenter Study
Scientific Title:Acronym
Prostate Cancer Screening Study of Risk Score (Pure Index) Using Urinary Spermine
Region
| Japan |
Condition
Condition
Suspected Prostate Cancer
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the usefulness of the Pure Index, calculated using a program that combines urinary spermine with other factors, as a secondary screening tool for detecting the presence of prostate cancer and aggressive prostate cancer in patients with elevated PSA levels suspected of having prostate cancer, in a multicenter collaborative study.
Basic objectives2
Others
Basic objectives -Others
Performance Evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROC Curve AUC for the PURE Index
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients aged 18 years or older at the time of obtaining consent.
Male patients suspected of having prostate cancer, with PSA test results meeting the following criteria (based on prostate cancer guidelines):
Aged 50 to 65 years: PSA level of 3.0 ng/mL or higher
Aged 65 to 70 years: PSA level of 3.5 ng/mL or higher
Other age groups: PSA level of 4.0 ng/mL or higher
Patients scheduled for a prostate biopsy due to suspicion of prostate cancer.
Individuals who have been adequately informed about the study, have a sufficient understanding, and have provided written consent of their own free will to participate in this study.
Key exclusion criteria
Patients under 20 years of age at the time of obtaining consent.
Dialysis patients.
Patients who have had a urinary tract infection requiring antibiotic treatment within 6 weeks prior to urine collection.
Patients who have had a Foley catheter or cystoscope inserted within 6 weeks prior to urine collection.
Patients who have undergone a digital rectal examination within 7 days prior to urine collection.
Patients who have used 5-alpha reductase inhibitors within 6 months prior to urine collection.
Patients who refuse to consent or are unable to consent to this study.
Others deemed unsuitable as study subjects by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisamitsu |
| Middle name | |
| Last name | Ide |
Organization
Juntendo University, Graduate School of Medicine
Division name
Digital therapeutics
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1227
h.ide.me@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ikehata |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1227
Homepage URL
y-ikehata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Nerima Hospital, Graduate School of Medicine
Nippon Medical School, Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University, Graduate School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
順天堂大学医学部附属練馬病院（東京都）
日本医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 05 | 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
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Implementation Period:
May 10, 2024 - March 31, 2026
Registration Period:
May 10, 2024 - December 31, 2025
Follow-up Period:
3 months
Type and Design of Study:
Prospective Observational Study
Study Subjects:
Patients suspected of having prostate cancer who visited or were hospitalized in the urology department of participating institutions between May 10, 2024, and December 31, 2025.
Case Registration Method:
Data Collection Period: May 10, 2024 - December 31, 2025
The principal investigator or co-investigator will obtain informed consent from the study subjects, conduct screening tests, and determine their eligibility. If consent is obtained, test results prior to consent may be used.
Planned Participation Period for Study Subjects:
Subjects will participate for a period of 3 months after giving consent.
Observation and Examination Items:
Age
Pre-Biopsy Diagnosis:
Serum PSA level
Free PSA level
Free-to-total PSA ratio (F/T ratio)
Urinary creatinine level
Prostate Biopsy Findings:
Date of biopsy
Number of biopsy cores
Number of positive cores
Gleason score of positive cores
Cancer percentage in positive cores
Prostate volume measured transabdominally and/or transrectally during biopsy
Radiological Imaging:
MRI (PI-RADS version 2 score, prostate volume)
Urinary Polyamines:
Putrescine
Spermine
Spermidine levels
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063032
