NCT03819751 MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
| NCT ID | NCT03819751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2019-03-18 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2019-03-18 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Cindy Mai, MD
PRINCIPAL INVESTIGATOR
University Hospital Leuven, Department of Radiology
Frequently Asked Questions
Who can join the NCT03819751 clinical trial?
This trial is open to male participants only, aged 50 Years or older, up to 75 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03819751 currently recruiting?
Yes, NCT03819751 is actively recruiting participants. Contact the research team at cindy.mai@uzleuven.be for enrollment information.
Where is the NCT03819751 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03819751 clinical trial?
NCT03819751 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Cindy Mai, MD at University Hospital Leuven, Department of Radiology. The trial plans to enroll 96 participants.
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