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Title   Prostate Cancer: S0925 Hormone-Sensitive Metastatic Prostate Ca
Description   A Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-Sensitive Metastatic Prostate Cancer

IRB Number   SWOG 0925
Category   Prostate
Inclusion/Notes   Pt must have had no more than 30 days of prior medical castration. If the method
of castration is luteinizing hormone releasing hormone (LHRH) agonists (leuprolide or
goserelin), the pt must be willing to continue the use of LHRH agonists and add
bicalutamide for combined androgen deprivation therapy (ADT) during protocol
treatment. If the pt was on a different antiandrogen (e.g. flutamide), the pt
must be willing to switch over to bicalutamide. If the method of castration was bilateral
orchiectomy, orchiectomy must have been performed within 30 days prior to
registration.
As a result, there are two pt populations eligible for the study: those who have not
started any androgen deprivation therapy (early induction group) and those who have
already started LHRH agonist and/or anti-androgens within the last 30 days (late
induction group). Pts must be registered within 30 days of first injection of LHRH
agonist or orchiectomy.
Status   Active
Start Date   02/11/2011
Principal Investigator (PI)   Jorge Nieva, MD
Contact Name   Judy Miller, RN
Contact Email   jmiller4@billingsclinic.org
Phone   (406) 435-7382
Fax   (000) 000-7489
Funding Source   NCI
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