Status:
COMPLETED
Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)
Lead Sponsor:
Advanced Medical Diagnostics s.a.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
Study design: -The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to...
Eligibility Criteria
Inclusion
- Age: \>or=18 year-old
- Histologically (positive biopsy) proven prostate cancer with primary and secondary Gleason patterns attributed.
- Patient planned to undergo radical prostatectomy
- Prostate cancer is deemed to be organ confined (T1-T2, Nx or No, Mx or Mo)
- No prior treatment for prostate cancer, including any type of hormonal therapy
- No major calcification is noted during the TRUS (i.e. (Diameter \>or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal).
- Patient willing to give written informed consent
Exclusion
- Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01191931
Start Date
February 1 2008
End Date
June 1 2012
Last Update
October 29 2012
Active Locations (7)
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1
Bordet Institute
Brussels, Brussels Capital, Belgium, 1000
2
UZ-Brussel
Brussels, Brussels Capital, Belgium, 1090
3
Olomouc Hospital
Olomouc, Czechia, 775 20
4
Universitätsklinikum Tübingen
Tübingen, Tübingen, Germany, 72076