- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01191931
Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02) (PHS-02)
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 histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set).
Study objectives:
Primary Objective:
- To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test.
Secondary Objectives:
- To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input.
- To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology.
- To assess the ability of PHS to rule in or rule out the presence of cancer > or = 0.5 cc and of > or = 0.2 cc as determined by histology.
- To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours > or = 0.5 cc and > or = 0.2 cc.
- To assess the ability of PHS to correctly risk stratify patients.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Tübingen, Allemagne, 72076
- Universitätsklinikum Tübingen
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Brussels, Belgique, 1000
- Bordet Institute
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Brussels, Belgique, 1090
- UZ-Brussel
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Budapest, Hongrie, H-1082
- Semmelweis University
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London, Royaume-Uni, NW1 2BU
- University College London Hospital (UCLH)
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London
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Hammersmith, London, Royaume-Uni, W6 8RF
- Imperial College Healthcare NHS Trust, Charing Cross Hospital
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Olomouc, République tchèque, 775 20
- Olomouc Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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 Criteria:
- Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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prostate cancer
Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Harry Bleiberg, MD
Publications et liens utiles
Publications générales
- Braeckman J, Autier P, Garbar C, Marichal MP, Soviany C, Nir R, Nir D, Michielsen D, Bleiberg H, Egevad L, Emberton M. Computer-aided ultrasonography (HistoScanning): a novel technology for locating and characterizing prostate cancer. BJU Int. 2008 Feb;101(3):293-8. doi: 10.1111/j.1464-410X.2007.07232.x. Epub 2007 Oct 8.
- Braeckman J, Autier P, Soviany C, Nir R, Nir D, Michielsen D, Treurnicht K, Jarmulowicz M, Bleiberg H, Govindaraju S, Emberton M. The accuracy of transrectal ultrasonography supplemented with computer-aided ultrasonography for detecting small prostate cancers. BJU Int. 2008 Dec;102(11):1560-5. doi: 10.1111/j.1464-410X.2008.07878.x. Epub 2008 Aug 14.
- Lucidarme O, Akakpo JP, Granberg S, Sideri M, Levavi H, Schneider A, Autier P, Nir D, Bleiberg H; Ovarian HistoScanning Clinical Study Group. A new computer-aided diagnostic tool for non-invasive characterisation of malignant ovarian masses: results of a multicentre validation study. Eur Radiol. 2010 Aug;20(8):1822-30. doi: 10.1007/s00330-010-1750-6. Epub 2010 Mar 20.
- Vaes E, Manchanda R, Nir R, Nir D, Bleiberg H, Autier P, Menon U, Robert A. Mathematical models to discriminate between benign and malignant adnexal masses: potential diagnostic improvement using ovarian HistoScanning. Int J Gynecol Cancer. 2011 Jan;21(1):35-43. doi: 10.1097/IGC.0b013e3182000528.
- Salomon G, Spethmann J, Beckmann A, Autier P, Moore C, Durner L, Sandmann M, Haese A, Schlomm T, Michl U, Heinzer H, Graefen M, Steuber T. Accuracy of HistoScanning for the prediction of a negative surgical margin in patients undergoing radical prostatectomy. BJU Int. 2013 Jan;111(1):60-6. doi: 10.1111/j.1464-410X.2012.11396.x. Epub 2012 Aug 9.
- Simmons LA, Autier P, Zat'ura F, Braeckman J, Peltier A, Romic I, Stenzl A, Treurnicht K, Walker T, Nir D, Moore CM, Emberton M. Detection, localisation and characterisation of prostate cancer by prostate HistoScanning(). BJU Int. 2012 Jul;110(1):28-35. doi: 10.1111/j.1464-410X.2011.10734.x. Epub 2011 Nov 17.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR2P00113
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