MRI Prostate for Chinese Men Being Screened for Prostate Cancer

January 3, 2024 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

The Use of MRI Prostate in Improving Detection of Significant Prostate Cancer in a Screening Population of Chinese Men With Elevated PSA

Under the prostate cancer screening protocol of the project 'Prevention of Obesity-related Cancers', men with elevated PSA with higher prostate cancer risk (PSA 4-10 ng/mL with high Prostate Health Index (PHI) ≥35, or PSA>10 ng/mL) will be offered a prostate biopsy.

In the current study, we would like to offer all screened men with elevated PSA in the range of 4-50 ng/mL a biparametric non-contrast MRI prostate (screening protocol) for any suspicious lesion in the prostate. If there is MRI lesion seen, additional targeted biopsies can be performed on top of the standard systematic prostate biopsies. It has been shown in a clinical Caucasian cohort that doing MRI-targeted biopsies resulted in improved detection of clinically significant prostate cancer compared with standard systematic biopsies.

In this study investigators would like to investigate the benefits of adding MRI prostate and MRI-targeted biopsy in the diagnostic pathway for prostate cancer in a screened cohort of Chinese men at risk of prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer (PCa) is the second most common cancer in the world, and its incidence in the Asia-Pacific region is increasing. While serum prostate specific antigen (PSA) level remains the commonest marker for screening of the disease, its specificity is very low. As a result, many patients with elevated PSA are subjected to transrectal ultrasound guided prostatic biopsy (TRUSPB) with negative result, but at the same time faced the complications of bleeding and infection from TRUSPB. Performing a standard 10-12 core systematic prostate biopsy in all men with elevated PSA was shown to miss some clinically significant prostate cancers while over-diagnosing some insignificant prostate cancers. In the European randomized study of screening for prostate cancer (ERSPC), PSA-based screening have resulted in reduced prostate cancer-specific death and metastasis, but there were problems like over-biopsy and over-diagnosis of indolent prostate cancers. The number needed to screen (NNS) to prevent one prostate cancer death was quite high at 781. Therefore, population-wide screening of men with PSA is not commonly applied in most places.

The blood test Prostate Health Index (PHI) provides much better prostate cancer risk stratification than PSA by dividing men with PSA 4-10 ng/mL. Using PHI 35 as a cutoff, clinically significant prostate cancer (any Gleason pattern ≥ 4) was found in only 0.7% in PHI<35, but up to 8.6% in PHI ≥35, a 12 fold difference. The use of PHI test could significantly reduce unnecessary prostate biopsies and was approved by FDA in 2012. Since 2016, the PHI blood test was available in the public health system in Hong Kong for men with PSA 4-10 ng/mL. According to local audit on 2795 men receiving PHI test, about 80% prostate biopsies was avoided. This also resulted in a higher positive biopsy rate (from 10.7% to 26.2%), with the potential of delayed diagnosis in only a minimal proportion of men (0.7%). Currently, PHI is being ordered regularly by Urologists in the public system of Hong Kong for men with PSA 4-10 ng/mL.

In a landmark study by Ahmed et al in 2017, performing multi-parametric MRI prostate before an initial prostate biopsy in a clinical Caucasian cohort has been shown to improve diagnosis of significant prostate cancer by 18%, while reduce diagnosis of insignificant prostate cancer by 5%.

Another Caucasian study by Alberts et al in 2017 in men who undergone the 5th round of screening in European Randomized Study of Screening for Prostate cancer Rotterdam, adding MRI prostate could avoid 65% biopsies and 68% insignificant prostate cancer, while detecting an equal percentage of significant cancers. The role of MRI in an Asian cohort under a screening protocol has not been reported before.

Prostate cancer incidence in Asian is only about one-third of that in Caucasian, and cancer detection rates in different PSA ranges are also 50% less. Reported Caucasian prostate cancer detection rates was 25-50% in men with PSA 4-10 ng/mL and >50% in men with PSA 10-20 ng/mL. In Hong Kong Chinese men, only 15% men with PSA 4-10 ng/mL and 20-30% men with PSA 10-20 ng/mL has prostate cancer. Therefore, screening tools like PHI or MRI are potentially more useful in reducing unnecessary biopsies in Chinese men even in higher PSA ranges (e.g. PSA > 10 ng/mL) due to much lower cancer detection rate.

A multiparametric MRI prostate combines T2-weighted (T2W), Diffusion-weighted imaging (DWI), and Dynamic contrast enhanced (DCE) sequences to aid identification of suspicious malignant lesions in the prostate using a standardized Prostate Imaging - Reporting and Data System (PI-RADS).

In a recently published meta-analysis, it is suggested that a bi-parametric (using only T2W and DWI sequences without contrast) MRI prostate has similar performance compared with a multi-parametric MRI prostate. Omitting the DCE and contrast injection reduces scanning time by 30-50% (down to 15-20 minutes per patient) and avoids risk of gadolinium contrast, especially in men with impaired renal function.

Under the prostate cancer screening protocol of the project 'Prevention of Obesity-related Cancers', men with elevated PSA with higher prostate cancer risk (PSA 4-10 ng/mL with high Prostate Health Index (PHI) ≥35, or PSA>10 ng/mL) will be offered a prostate biopsy.

In the current study, investigators would like to offer all screened men with elevated PSA in the range of 4-50 ng/mL a biparametric non-contrast MRI prostate (screening protocol) for any suspicious lesion in the prostate. If there is MRI lesion seen, additional targeted biopsies can be performed on top of the standard systematic prostate biopsies. It has been shown in a clinical Caucasian cohort that doing MRI-targeted biopsies resulted in improved detection of clinically significant prostate cancer compared with standard systematic biopsies.

In this study investigators would like to investigate the benefits of adding MRI prostate and MRI-targeted biopsy in the diagnostic pathway for prostate cancer in a screened cohort of Chinese men at risk of prostate cancer.

Study Type

Observational

Enrollment (Estimated)

690

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital, Chinese University of Hong Kong
        • Contact:
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • North District Hospital
        • Contact:
          • Wilson Hoi-Chak CHAN, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited form the the project 'Prevention of Obesity-related Cancers". 5000 Chinese men between age 50 and 75 will be screened for prostate cancer with the blood test PSA.

Description

Inclusion Criteria:

  1. Men being screened for prostate cancer in the project 'Prevention of Obesity-related Cancers'
  2. Age 50-75
  3. Screening naïve, defined as no blood taking for PSA within past 5 years AND no prostate biopsy within past 5 years
  4. PSA 4-50 ng/mL
  5. Agree for non-contrast MRI scanning of prostate

Exclusion Criteria:

  1. Men who are contraindicated for MRI( Pacemaker in-situ, Metallic implants which are not MRI-compatible, or Claustrophobia)
  2. Prior history of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRI pathway
Plain biparametric MRI prostate applied to men with elevated PSA, on top of standard screening pathway using PSA and Prostate Health Index
Diagnostic test: MRI prostate
plain biparametric MRI prostate
Standard screening pathway
Intervention: Using blood tests PSA and Prostate Health Index to screen men at risk of prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In men with higher risk of prostate cancer, the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.
Time Frame: Baseline (only one-time point)
In men with higher risk of prostate cancer (PSA 10-50 ng/mL, or PSA 4-10 AND Prostate Health Index ≥35), the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.
Baseline (only one-time point)
In men with lower risk of prostate cancer the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.
Time Frame: Baseline (only one-time point)
In men with lower risk of prostate cancer (PSA 4-10 ng/mL AND Prostate Health Index <35), the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.
Baseline (only one-time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gleason ≥4 cancer AND Maximal cancer core length ≥6mm
Time Frame: Baseline (only one-time point)
The proportion of men diagnosed with Gleason ≥4 cancer AND Maximal cancer core length ≥6mm
Baseline (only one-time point)
The number of MRI needed to detect one extra clinically significant prostate cancer compared to standard screening pathway
Time Frame: Baseline (only one-time point)
The number of MRI needed to detect one extra clinically significant prostate
Baseline (only one-time point)
The proportion of men that a biopsy can be avoided by using MRI in higher and lower risk groups
Time Frame: Baseline (only one-time point)
The proportion of men that a biopsy can be avoided by using MRI in higher and lower risk groups
Baseline (only one-time point)
In men with MRI suspicious lesion (PI-RADS 3 or above), clinically significant prostate cancer diagnosed on Systematic biopsy cores versus targeted biopsy cores
Time Frame: Baseline (only one-time point)
In men with MRI suspicious lesion (PI-RADS 3 or above), clinically significant prostate cancer diagnosed on Systematic biopsy cores versus targeted biopsy cores
Baseline (only one-time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCP, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2019

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2018.495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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