Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00601

2 Trial Registration Date

2018-04-10

i Registration Status

Prospective

3 Secondary IDs

CRE-2017.491

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ka-Fung Peter CHIU

ii Address

Department of Surgery, 4/F, LCW Clinical Science Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, HKSAR China

iii Phone

3505-1663

iv Email

peterchiu@surgery.cuhk.edu.hk

v Affiliation

Division of Urology, Department of Surgery, Prince of Wales Hospital

vi Country

HKSAR China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ka-Fung Peter CHIU

ii Address

Department of Surgery, 4/F, LCW Clinical Science Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, HKSAR China

iii Phone

3505-1663

iv Email

peterchiu@surgery.cuhk.edu.hk

v Affiliation

Division of Urology, Department of Surgery, Prince of Wales Hospital

vi Country

HKSAR China

9 Official Scientific Title of the Study

A Pilot study on the effect of 5-alpha reductase inhibitor on p2PSA and Prostate Health Index (PHI)

10 Public Title

A Pilot study on the effect of 5-alpha reductase inhibitor on p2PSA and Prostate Health Index (PHI)

i Public Title in Chinese 研究名稱

5α還原酶抑制劑對於血液p2PSA及前列腺健康指數(PHI)的影響：一個先導性研究

11 Short Title (Optional)

12 Countries of Recruitment

HKSAR China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-11-24

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2017.491

14 Medical Condition Being Studied

Benign Prostatic Hyperplasia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Finasteride

iii Dosage form of the intervention

Oral

iv Dosage of the intervention

5mg

v Duration of the intervention

1 Year

vi Frequency of the intervention

daily

16 Comparative Treatments

i Description/ name of comparative treatments

Control

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Ethnically Chinese men

Age 50-80 years

Serum total PSA 4-10ng/mL with normal DRE at baseline

Prostate size > 30ml on TRUS

History of negative TRUSPB within last 6 months

Informed consent signed by patient

ii Exclusion Criteria

Prior history of prostate cancer

Patient taking 5-alpha reductase inhibitor (Finasteride or Dutasteride) within 12 months before recruitment

Patient taking long term (>3 months) androgen or steroidal drugs within 12 months before recruitment

Active urinary tract infection or prostatitis

Bladder stone

Patient on indwelling catheter or on intermittent catheterization of bladder

iii Age Minimum

50

iv Age Maximum

80

v Gender

Male

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-04-09

21 Target Sample Size

150

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

The change of p2PSA and PHI level after taking 5-alpha reductase inhibitor at 1 year

ii The metric or method of measurement used

PHI level on baseline, 6th month and 12th month

iii The timepoint(s) of primary interest

Baseline, 6th month and 12th month

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-04-11

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-04-10