The primary objective of this study is to compare HistoScanningTM guided prostate biopsy with systematic biopsy in the detection of prostate cancer in men candidate for a first or second biopsy procedure.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint for cancer detection is a binary variable in terms of benign
or malignant.
Secondary outcome
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.
Background summary
Biopsies are taken systematically from the prostate without an imaging
technique that allows us to visualize areas suspicious of cancer. Various
studies conducted have shown that up to 35% of all clinically significant
prostate cancers are not detected by systematic biopsy. In this study we will
evaluate the potential of HistoScanningTM guided biopsy to increase the
detection rate of prostate cancer.
Study objective
The primary objective of this study is to compare HistoScanningTM guided
prostate biopsy with systematic biopsy in the detection of prostate cancer in
men candidate for a first or second biopsy procedure.
Study design
Observational pilot study. Patients will receive a HistoScanning prior to the
biopsy procedure. In case one or more lesions of >= 0.2 cm3 are seen with
HistoScanning a maximum of 4 HistoScanning guided prostate biopsy cores are
taken in addition to the standard systematic prostate biopsies (8, 10 or 12
biopsies, dependent on prostate volume).
Study burden and risks
The HistoScanning procedure should, from the patient*s perspective, be no
different from standard diagnostic transrectal ultrasonography. The systematic
and HistoScanning guided biopsy will be performed in the same session, so no
extra visit is required. A maximum of 4 HistoScanning guided biopsy cores will
be performed in addition to the standard systematic biopsy. Accordingly the
number of bioptic cores taken in this study will not exceed 16.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30800.078.09 |