Clinical trial · Observational
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values: Can we Save Some MRI Scans?
NCT05438524CI-TRIAL-00082928completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to investigate, in a larger cohort of consecutive men, the proportion of abnormal MRI prostate in different phi ranges, and the cancer detected in Chinese men with abnormal MRI. This study aims to evaluate whether MRI prostate can be omitted in men with lower suspicion of prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
- timeFrame
- Baseline (only one-time point)
- description
- In men with higher risk (phi\>35) of significant prostate cancer), proportion of men with abnormal MRI.
- measure
- In men with lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
- timeFrame
- Baseline (only one-time point)
- description
- In men with lower risk (phi\<35) of significant prostate cancer), proportion of men with abnormal MRI.
Secondary outcomes (3)
- measure
- Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate
- timeFrame
- Baseline (only one-time point)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ethnically Chinese Men ≥18 years of age * Clinical suspicion of prostate cancer and indicated for prostate biopsy * Serum Prostate-specific antigen (PSA) 4-10 ng/mL * Serum Prostate health index (phi) result available * Normal Digital rectal examination * Able to provide written informed consent Exclusion Criteria: * Past or current history of prostate cancer * On 5-alpha reductase inhibitor in the past 6 months (e.g. Finasteride, Dutasteride) * MRI prostate performed in past 5 years * Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate \< 50ml/min in serum renal function test within 3 months) * Contraindicated for prostate biopsy (e.g. uncorrectable coagulopathy, active infection
References
Publications (18)
- BACKGROUNDCulp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020 Jan;77(1):38-52. doi: 10.1016/j.eururo.2019.08.005. Epub 2019 Sep 5. PMID 31493960
- BACKGROUNDChan SY, Ng CF, Lee KW, Yee CH, Chiu PK, Teoh JY, Hou SS. Differences in cancer characteristics of Chinese patients with prostate cancer who present with different symptoms. Hong Kong Med J. 2017 Feb;23(1):6-12. doi: 10.12809/hkmj164875. Epub 2016 Dec 9. PMID 27932742
- BACKGROUNDWong HF, Yee CH, Teoh JY, Chan SY, Chiu PK, Cheung HY, Hou SS, Ng CF. Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades. Asian J Androl. 2019 Jan 1;21(1):104-106. doi: 10.4103/aja.aja_75_18. No abstract available. PMID 30178778
- BACKGROUNDPresti JC Jr, O'Dowd GJ, Miller MC, Mattu R, Veltri RW. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol. 2003 Jan;169(1):125-9. doi: 10.1016/S0022-5347(05)64051-7. PMID 12478119
- BACKGROUNDCarter HB, Hamper UM, Sheth S, Sanders RC, Epstein JI, Walsh PC. Evaluation of transrectal ultrasound in the early detection of prostate cancer. J Urol. 1989 Oct;142(4):1008-10. doi: 10.1016/s0022-5347(17)38971-1. PMID 2677409
- BACKGROUNDChiu PK, Alberts AR, Venderbos LDF, Bangma CH, Roobol MJ. Additional benefit of using a risk-based selection for prostate biopsy: an analysis of biopsy complications in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. BJU Int. 2017 Sep;120(3):394-400. doi: 10.1111/bju.13913. Epub 2017 Jun 5. PMID 28498624
- BACKGROUNDChiu PK, Ng CF, Semjonow A, Zhu Y, Vincendeau S, Houlgatte A, Lazzeri M, Guazzoni G, Stephan C, Haese A, Bruijne I, Teoh JY, Leung CH, Casale P, Chiang CH, Tan LG, Chiong E, Huang CY, Wu HC, Nieboer D, Ye DW, Bangma CH, Roobol MJ. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol. 2019 Apr;75(4):558-561. doi: 10.1016/j.eururo.2018.10.047. Epub 2018 Nov 2.