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Endorectal Coil Magnetic Resonance Images

Phase 2

Prostatic Neoplasms | Unknown | Oncology |Abbott Laboratories|Last Updated: Aug 11, 2010

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00160953Endorectal Coil Magnetic Resonance Images (ERC-MRI)PHASE2 COMPLETED 20 — — Feb 1, 2005Feb 1, 2010Aug 11, 20101 Canada
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Study Endpoints
Primary Endpoints
The primary aim of this study is to develop a prostate deformation model using the finite element method from anatomic MR images of the prostate gland acquired with and without ERC.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
Endorectal Coil Magnetic Resonance ImagesPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * adenocarcinoma of the prostate * patient undergoing dose escalated conformal EBRT * low or intermediate risk prognostic factors: PSA \< or equa to20, gleason score \<8, T \<T3, N category 0 or X, M category 0 or X * \> or equal to 18 years of age * ECOG performance status 0 or...

Countries:Canada
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