IGPC-2Multi-modality Prostate Cancer Image Guided Interventions
Imaging Panel
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude diagnostique
Résumé
Date de début de l'étude : 12 février 2012
Date à laquelle le premier participant a commencé l'étude.This study was built on our first study (IGPC-1, REB number 15551) which acquired multi-modality imaging in 36 patients undergoing radical prostatectomy. We successfully demonstrated the ability to accurately co-register pre-operative multi-modality images (MRI: T1, T2, Diffusion Weighed (DW), Dynamic Contrast enhanced (DCE); Dynamic Contrast Enhanced CT, 3D Ultrasound with post-operative whole mount pathology specimens. We have developed a platform for the segmentation of prostate cancer on the whole mount pathology specimens and are in the process of analyzing the data to develop a hybrid imaging map (HIM) of prostate cancer distribution (location and grade) based on the correlation of the pre-operative imaging signals and the post-operative pathology (citation provided below). The HIM will need subsequent validation in a separate cohort of radical prostatectomy patients and evaluated as to its ability to be incorporated as a targeting tool for prostate interventions such as prostate biopsy and this is the purpose of this follow-up study. On the IGPC-2 study, pre-operative imaging panels were successfully obtained in 24 patients accrued to cohort 1. The protocol was then amended to include \[18-F\]-DCFPyl instead of \[18F\]-FCH. \[18-F\]-DCFPyl was a newer PET probe that may possess superior performance because it is directed against prostate specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells. Imaging-pathology correlations in the first 6 patients imaged with \[18-F\]-DCFPyl were compared to the correlations obtained with \[18F\]-FCH imaging in the first 24 patients. IGPC-2 Cohort 1 (Radical Prostatectomy) was expanded to provide an additional 20 men imaged with \[18-F\]-DCFPyl as part of the imaging panel. The goal was to acquire 24 complete imaging datasets with \[18-F\]-DCFPyl as the PET imaging agent to enable us to draw comparisons with the 24 \[18F\]-FCH imaging data sets acquired.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.52 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Provision of informed consent for this study * Male, aged 18 years or older * Pathologically confirmed prostate cancer on previous biopsy * Suitable for and consenting to Radical Prostatectomy for treatment, or repeat biopsy as standard of care Exclusion Criteria: * Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only * Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible. * Inability to comply with the pre-operative imaging panel * Patients scheduled for radical prostatectomy with prostate size exceeding dimensions for whole mount pathology slides * Allergy to contrast agents to be used as part of the imaging panel * Sickle cell disease or other anemias * Insufficient renal function (eGFR \< 60 mL/min/1.73 m2) * Residual bladder volume \> 150 cc (determined by post-void ultrasound) * Hip prosthesis, vascular grafting that is MRI incompatible or sources of artifact within the pelvis * Contraindication to MRI * pacemaker or other electronic implants * known metal in the orbit * cerebral aneurysm clips
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site