A pilot study to compare HistoScanning guided prostate biopsy with systematic biopsy in the detection of prostate cancer.
Completed
- Conditions
- prostate cancerProstate carcinoma1003859710036958
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
• 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint for cancer detection is a binary variable in terms of benign<br /><br>or malignant. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of standard and HistoScanning guided cores, number of positive standard<br /><br>and HistoScanning guided cores, length of standard and HistoScanning guided<br /><br>core, % of standard and HistoScanning guided core infiltrated with cancer,<br /><br>Gleason score of standard and HistoScanning guided biopsies, prostate volume,<br /><br>baseline PSA, PSA density, results of digital rectal examination (DRE), TRUS<br /><br>and HistoScanning analysis.</p><br>