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Trial Detail

CUHK_CCRB00601

2018-04-10

Prospective

CRE-2017.491

The Chinese University of Hong Kong

The Chinese University of Hong Kong

N/A

Not Applicable

Ka-Fung Peter CHIU

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

35051663

peterchiu@surgery.cuhk.edu.hk

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

HKSAR China

Ka-Fung Peter CHIU

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

35051663

peterchiu@surgery.cuhk.edu.hk

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

HKSAR China

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

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

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

HKSAR China

Yes

2017-11-24

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2017.491

Benign Prostatic Hyperplasia

Drug

Finasteride

Oral

5mg

1 Year

daily

Control

NA

NA

NA

NA

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

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

50

80

Male

Observational

Not Applicable

Not Applicable

Not Applicable

Not Applicable

4

2018-04-10

150

Recruiting

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

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

Baseline, 6th month and 12th month

NA

NA

NA

No

2019-04-11

ChiCTR1800015672

2018-04-10

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