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PET/CT, PET/MRI, mpMRI

Phase 2

Prostate Carcinoma | Unknown | Oncology |GE HealthCare Technologies Inc.|Last Updated: Oct 21, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02002455Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRIPHASE2 COMPLETED 26Dec 1, 2013Jun 1, 2016Oct 21, 20161 Finland
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Study Endpoints
Primary Endpoints
Diagnostic accuracy of hybrid PET/MRI with FACBC
1 years

By comparing tracer uptake and imaging findings at MRI in each sextant with macroslices obtained at radical prostatectomy sensitivity, specificity, positive and negative predictive value and accuracy will be calculated

Secondary Endpoints
Biochemical relapse free survival (bRFS)
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Multimodality imagingEXPERIMENTALPET/CT, PET/MRI, mpMRI
Interventions
NameTypeDescription
PET/CT, PET/MRI, mpMRIDEVICEFACBC dose 370 megabecquerel (MBq)
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Eligibility Criteria
Age Range50 Years — 85 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age: 50 to 85 years old * Language spoken: Finnish or Swedish * Diagnosis: Histologically confirmed adenocarcinoma of prostate * Adequate histological sampling consisting of at least 3 biopsy samples from each lobe * No previous surgical, radiation or endocrine treatment for p...

Countries:Finland
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