Conditions: Cancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors
Keywords: Androgen deprivation therapy for non-metastatic prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 384
Healthy volunteers: no

Brief summary:
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Denosumab
Intervention descriptions: intervention 1: 60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Protocol document: