Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
MALE
NCT06402552

Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy

Led by Chang Gung Memorial Hospital · Updated on 2024-05-10

370

Participants Needed

1

Research Sites

87 weeks

Total Duration

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AI-Summary

What this Trial Is About

3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial. 3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core. 3.2.2 Secondary endpoints: 1. The proportion of men with a diagnosis of any PCa 2. The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa) 3. The proportion of men with a diagnosis of csPCa 4. Only in targeted biopsy 5. Only in systematic biopsy 6. The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.

CONDITIONS

Official Title

Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy

Who Can Participate

Age: 50Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 50 years or older
  • Clinical suspicion of prostate cancer and indication for prostate biopsy
  • Serum prostate-specific antigen (PSA) between 4 and 20 ng/mL
  • Eligible for MRI study
  • Digital rectal examination showing organ-confined cancer (cT2 or less)
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Prior prostate biopsy within 6 months before screening
  • Previous diagnosis of prostate cancer
  • Contraindications to prostate biopsy such as active urinary tract infection, failed transrectal ultrasound probe insertion, uncorrectable bleeding disorders, or use of antiplatelet/anticoagulant medications that cannot be stopped (low-dose aspirin allowed)
  • Contraindications to MRI including contrast allergy, claustrophobia, or presence of intra-abdominal metal foreign bodies
  • Refusal or loss of follow-up before biopsy
  • Prior treatments for prostate cancer including hormone therapy, immunotherapy, chemotherapy, or pelvic radiation
  • Withdrawal of informed consent
  • Inability to complete scheduled MRI exams or MRI images of insufficient quality to detect or exclude clinically significant prostate cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan, 333

Actively Recruiting

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Research Team

S

See-Tong Pang, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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