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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016934
Receipt No. 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

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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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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