Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI Prostate for Chinese Men Being Screened for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891732
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
CHIU Ka Fung Peter, Chinese University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment
Prostate Cancer PSA MRI Diagnostic Test: MRI prostate

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of MRI Prostate in Improving Detection of Significant Prostate Cancer in a Screening Population of Chinese Men With Elevated PSA
Actual Study Start Date : January 19, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891732


Contacts
Layout table for location contacts
Contact: Peter Ka Fung CHIU, MBChB 852-3505-2625 peterchiu@surgery.cuhk.edu.hk
Contact: Pui Tak LAI, BN 852-3505-1663 francolai@surgery.cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Peter Ka Fung CHIU, MBChB    852-3505-2625    peterchiu@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Publications:

Layout table for additonal information
Responsible Party: CHIU Ka Fung Peter, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03891732    
Other Study ID Numbers: 2018.495
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHIU Ka Fung Peter, Chinese University of Hong Kong:
Prostate cancer
PSA
MRI
Biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases