Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
MALE
NCT03819751

MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

96

Participants Needed

1

Research Sites

328 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.

CONDITIONS

Official Title

MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection

Who Can Participate

Age: 50Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male subjects aged 50 to 75 years
  • Willing to participate by giving written informed consent
  • Clinical suspicion of prostate cancer with elevated PSA and/or abnormal digital rectal exam
  • Good health based on medical history, physical exam, and vital signs
  • Presence of a suspicious lesion on prostate MRI (PI-RADS 3 to 5)
Not Eligible

You will not qualify if you...

  • Prior history of prostate cancer
  • Previous prostate biopsy
  • Contraindications for MRI such as claustrophobia or incompatible metal implants
  • Evidence of lymph node involvement on prostate MRI or abdominal CT
  • Evidence of bone metastasis on bone scan
  • Prior hip prosthesis, pelvic radiation therapy, or androgen deprivation therapy
  • Unable to undergo transrectal ultrasound due to prior rectal surgery or active rectal diseases
  • Any condition that may interfere with study compliance or follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-brabant, Belgium, 3000

Actively Recruiting

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Research Team

C

Cindy Mai, MD

CONTACT

F

Frederik De Keyzer

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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