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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 25, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for performing a biopsy on the prostate to see if they can accurately detect prostate cancer. The study will involve men who are suspected of having prostate cancer, based on high levels of a specific blood test called PSA or an abnormal physical exam. Researchers want to understand which method works better—using advanced software to target the biopsy or relying on a doctor's visual assessment.

To be eligible for this study, participants need to be healthy men aged between 50 and 75 who do not have a history of prostate cancer or prior biopsies. They should also have a suspicious area identified on an MRI scan. If you choose to participate, you will undergo a biopsy procedure, and your experiences and results will help improve how prostate cancer is diagnosed in the future. It's important to note that if you have certain medical conditions or previous treatments, you may not be able to join the study.

Gender

MALE

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.