SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy +TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostrate Cancer

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SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy +TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostrate Cancer

Primary: overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide

Secondary:
a. To compare progression free survival (as defined in Section 10.5) between the two arms
b. To compare distributions of PSA response (< 0.2 vs. 0.2-4.0 vs. > 4.0 ng/ml) between the treatment arms at 7 months post-randomization.
c. To compare the qualitative and quantitative adverse events from each treatment arm.
d. To characterize the long-term survival in both treatment arms after 10 years of follow-up.

Protocol Number081308
Principal InvestigatorTina Mayer
PhasePhase III
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedCASODEX(Bicalutamide)
TAK-700 (orteronel)
Participating InstitutionsRobert Wood Johnson University Hospital at Hamilton
Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.