UMIN-CTR Clinical Trial

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

Prostate cancer

Classification by specialty

Urology

Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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 ).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Beckman Coulter Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2015

Year

03

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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