Comparing MRI-targeted biopsy techniques for prostate cancer detection
MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection
This study is testing two different biopsy methods to see which one is better at finding prostate cancer in men aged 50 to 75 who have high PSA levels and concerning MRI results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven, Vlaams-brabant) |
| Trial ID | NCT03819751 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of two biopsy techniques for detecting prostate cancer in men aged 50 to 75 years who have elevated PSA levels and suspicious MRI findings. Participants will undergo both software and visual registration biopsy methods, as well as traditional systematic biopsies, with the order of the procedures randomized. The study aims to determine the efficacy of these techniques by comparing histopathological results, specifically cancer core length and percentage, against a reference standard. Follow-up will continue for two years to assess treatment outcomes according to established guidelines.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 to 75 years with clinical suspicion of prostate cancer and MRI findings indicating suspicious lesions.
Not a fit: Patients with a prior history of prostate cancer or those who have undergone previous prostate biopsies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of prostate cancer detection, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results with MRI-targeted biopsy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven, Vlaams-brabant
- UZ Leuven — Leuven, Vlaams-brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Cindy Mai, MD — University Hospital Leuven, Department of Radiology
- Study coordinator: Cindy Mai, MD
- Email: cindy.mai@uzleuven.be
- Phone: 016345032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.