the Beijing Randomized Study Of Prostate Cancer Screening

NCT05961514 | Unknown

• 1 other identifier: 2022-1G-1021
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA \> 4ng/ml in initial screening.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRI; Biopsy

Outcome Measures

Primary Outcomes (1)

• detection of clinically significant prostate cancer （Gleason Score ≥7）

  Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

  At 2 months after the last included biopsy procedure

Secondary Outcomes (1)

• detection of clinically insignificant prostate cancer （Gleason Score 3+3）

  At 2 months after the last included biopsy procedure

Study Arms (2)

Traditional

OTHER

The traditional/control arm consists of systematic biopsies of the prostate if PSA\>4ng/ml.

Diagnostic Test: systemic biopsies

Experimental

EXPERIMENTAL

The experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA\>10ng/ml.

Diagnostic Test: Target biopsies

Interventions

Target biopsies DIAGNOSTIC_TEST

MRI/Fusion target biopsies combine magnetic resonance imaging (MRI) with ultrasound-guided biopsy techniques to obtain tissue samples from areas of the prostate gland that appear abnormal on MRI.

Experimental

systemic biopsies DIAGNOSTIC_TEST

transrectal ultrasound (TRUS) guided prostate systemic biopsies

Traditional

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men aged 60-75 with a life expectancy of more than 10 years;
• Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer;
• Willing to participate in this project.

You may not qualify if:

• Previously diagnosed with prostate cancer;
• Previously diagnosed with any malignant tumor within the past 5 years;
• Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole;
• Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week;
• Have other serious illnesses or cannot perform activities of daily living independently.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital &institute

Beijing, Beijing Municipality, 100036, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Yudong Cao, Dr.

CONTACT

+8615110101301; ydcao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: October 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-03

Locations

CN (1)