UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016934 |
|---|---|
| Receipt number | R000019660 |
| Scientific Title | Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2018/06/07 15:13:57 |
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Basic information
Public title
Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
Acronym
Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. (PROPHET).
Scientific Title
Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
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 | |
| Middle name | |
| Last name | Kazuto Ito |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-39-22, Showa-machi, Maebashi-city, Gunma 371-8511, Japan
TEL
027-220-8301
Homepage URL
kzito@gunma-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019660
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