Status:
RECRUITING
MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Prostate Cancer
Prostate Neoplasm
Eligibility:
MALE
50-75 years
Phase:
NA
Brief Summary
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 le...
Detailed Description
Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antig...
Eligibility Criteria
Inclusion
- willing to participate in the study by giving written informed consent.
- male subjects aged between 50 to 75 years.
- with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
- good health condition based on medical history, physical examination and vital sign measurements.
- with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
Exclusion
- has a prior history of prostate cancer.
- had prior prostate biopsy.
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has evidence of lymph nodes involvement on prostate MRI or abdominal CT
- has evidence of bone metastasis on bone scan.
- has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
- unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)
- has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03819751
Start Date
March 18 2019
End Date
July 1 2025
Last Update
July 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000