|- candidate number||8091|
|- NTR Number||NTR2342|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mei-2010|
|- Secondary IDs||MEC-2010-007 / NL30800.078.09 METC Erasmus MC / CCMO|
|- Public Title||Comparisson of HistoScannnig guided prostate biopsy with systematic prostate biopsy in the detection of prostate cancer.|
|- Scientific Title||A pilot study to compare HistoScanning guided prostate biopsy with systematic biopsy in the detection of prostate cancer.|
|- hypothesis||In this study we will evalute the potention of HistoScanning guided biopsy to increase the detection rate of prostate cancer.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Prostate biopsy, Computer aided ultrasonography|
|- Inclusion criteria||1. Male patient aged ≥ 40 years;|
2. 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;
3. Provides written informed consent and is willing and able to comply with protocol requirements.
|- Exclusion criteria||1. A history of previous prostate surgery;|
2. Clinically apparent prostatitis within one month of biopsy;
3. Active urinary tract infection;
4. Has received a bioptic procedure within 30 days before admission into this study;
5. Incapable of understanding the language in which the information for the patient is given.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||26-apr-2010|
|- planned closingdate||30-jul-2010|
|- Target number of participants||30|
|- Interventions||There will be no intervention. Patients undergo systematic and guided biopsies (invasive measurement).|
|- Primary outcome||Binary variable in terms of benign or malignant.|
|- Secondary outcome||1. Gleason score;|
2. Proportion of positive biopsy cores.
|- Timepoints||There will be no follow-up. Patients visit the clinic once for the combined systematic and guided biopsy procedure.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. S. Heuvel, van den|
|- CONTACT for SCIENTIFIC QUERIES||Drs. S. Heuvel, van den|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Urology|
|- Brief summary||Rationale:|
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.
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.
Observational pilot study.
Men ≥ 40 years old with a clinical suspicion of prostate cancer and candidate for a bioptic procedure. The study population comprises both candidates for a first bioptic exam and candidates for a second bioptic procedure having a previous negative result independently from the present 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).
Main study parameters/endpoints:
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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The HistoScanning procedure should, from the patientís 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.
|- Main changes (audit trail)|
|- RECORD||27-mei-2010 - 5-jun-2010|