Prostate health index density in the diagnosis of clinically significant prostate cancer in equivocal magnetic resonance imaging of the prostate in the Taiwan community

ISRCTN	ISRCTN66525057
DOI	https://doi.org/10.1186/ISRCTN66525057
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	VGHTPE No. 2017-08-017A
Sponsor	Taipei Veterans General Hospital
Funder	Investigator initiated and funded

Submission date: 29/02/2024
Registration date: 05/03/2024
Last edited: 17/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study investigates the efficacy of prostate health index density (PHID) for the guidance of MRI-directed prostate biopsies in accurately identifying clinically significant prostate cancers (csPCa), with a focus on populations within Taiwan.

Who can participate?
Men with Prostate Health Index (PHI) and MRI-guided targeted and/or systematic prostate biopsy performed were included.

What does the study involve?
This study involves collecting information from multiple medical centers in Taiwan about prostate biopsies. We're looking at various factors like PSA levels, prostate size, Prostate Health Index, and how these relate to MRI PI-RADS scores using different analytical methods. Our goal is to identify clinically significant prostate cancer (csPCa), which is cancer that has a meaningful impact on health, particularly focusing on minimizing unnecessary biopsies.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Taipei Veterans General Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
April 2016 to Dec 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Ching-Hsin Chang, jossp1029@gmail.com

Contact information

Dr Ching-hsin Chang
Public, Scientific, Principal investigator

No. 252, Wuxing St, Xinyi District
Taipei City
110
Taiwan

ORCID ID	0000-0003-4055-8853
Phone	+886-2-2737-2181
Email	123001@h.tmu.edu.tw

Study information

Primary study design	Observational
Study design	Observational cohort
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Prostate Health Index Density in the diagnosis of Clinically significant prostate cancer in PI-RADS 3 of prostate mpMRI in the Taiwan community
Study objectives	We put more interest in the proper PHID cut-off value among mpMRI PI-RADS 3 patients. Eventually, we want to establish a flowchart for Taiwanese, including PSA, PHID, and mpMRI.
Ethics approval(s)	Ethics approval not required
Ethics approval additional information	This protocol was based on the current clinical practice
Health condition(s) or problem(s) studied	Prostate cancer screening
Intervention	This is a multicenter study of Taiwan men with PHI and MRI-targeted and systematic prostate biopsies performed. From 2016 to 2022, after obtaining informed consent, we enrolled patients who were more than 40 years and underwent MRI-targeted prostate biopsy for suspicious PCa due to elevated serum PSA level (PSA > 4 ng/mL) Prostate biopsy derived from both MRI-targeted and systematic biopsies. The database included data from 3 medical centers in Taiwan. The algorithm was modified from pilot studies. Patients included in the database had blood samples collected prior to MRI-targeted and systematic prostate biopsies. The collected blood samples were tested for total PSA, free PSA, and p2PSA. PHI was then calculated by using the formula, [(p2PSA /fPSA) X √PSA]. In addition, mpMRI at 1.5 or 3 T was performed in all patients. PHID was calculated by PHI divided by prostate volume on MRI. Reporting of mpMRI prostate was done according to PI-RADS version 2.0. All men in this study received transrectal or transperineal MRI-targeted and systematic biopsies. Pathology reporting was performed according to The International Society of Urological Pathology (ISUP) Gleason grade group (GG). Clinically signiﬁcant PCa was deﬁned as ISUP GG ≧ 2 PCa.
Intervention type	Other
Primary outcome measure(s)	Prostate cancer measured using the pathology report taken at a single time point.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	40 Years
Upper age limit	70 Years
Sex	Male
Target sample size at registration	450
Total final enrolment	420
Key inclusion criteria	Patients who were more than 40 years old and underwent MRI-targeted prostate biopsy for suspicious PCa due to elevated serum PSA level (PSA > 4 ng/mL)
Key exclusion criteria	Prostate malignancy diagnosed before
Date of first enrolment	01/04/2016
Date of final enrolment	31/12/2022

Locations

Countries of recruitment

Taiwan

Study participating centres

Taipei Veterans General Hospital

No.201, Sec. 2, Shipai Rd., Beitou District
Taipei City
11217
Taiwan

National Taiwan University Hospital

No.1, Changde St., Zhongzheng Dist., 100229
Taipei City
100229
Taiwan

China Medical University Hospital

No. 2, Yude Rd., North Dist.
Taichung City
404327
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	available on request (Dr. Ching-Hsin Chang, chinghsin.chang@gmail.com)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2024	17/07/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2024: Publication reference added.
04/03/2024: Trial's existence confirmed by Taipei Veterans General Hospital.