prostate cancer Prostate carcinoma
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male patient aged >= 40 years. • Patient with a clinical suspicion of prostate cancer and scheduled for first bioptic procedure or patient who already received one systematic biopsy procedure with negative results currently under follow-up procedure due to a persistent indication. • Provides written informed consent and is willing and able to comply with protocol requirements.
Exclusion criteria
Exclusion criteria: • A history of previous diagnosis of prostate cancer or prostate surgery. • Clinically apparent prostatitis within one month of biopsy. • Active urinary tract infection. • Has received a bioptic procedure within 30 days before admission into this study. • Incapable of understanding the language in which the information for the patient is given.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint for cancer detection is a binary variable in terms of benign or malignant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of standard and HistoScanning guided cores, number of positive standard and HistoScanning guided cores, length of standard and HistoScanning guided core, % of standard and HistoScanning guided core infiltrated with cancer, Gleason score of standard and HistoScanning guided biopsies, prostate volume, baseline PSA, PSA density, results of digital rectal examination (DRE), TRUS and HistoScanning analysis. | — |
Countries
Netherlands
Outcome results
None listed