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

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

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.

Conditions3

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