Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors
Conditions
Keywords
Androgen deprivation therapy for non-metastatic prostate cancer
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.
Interventions
DRUGDenosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be currently participating in the 20040138 Amgen study * Subjects must sign the informed consent before any study specific procedures are performed.
Exclusion criteria
* Subjects with any prior diagnosis of bone metastasis * Known hypocalcemia * Developed sensitivity to mammalian cell derived drug products during the 20040138 study * Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study * Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Through Month 24 | 24 months |
Countries
Canada, Finland, Hungary, Mexico, Poland, United States
Participant flow
Recruitment details
First subject enrollment date: 18 February 2009; Last subject enrollment date: 11 May 2010
Pre-assignment details
Only recruited those who were participating in the safety follow-up of 20040138 study at the time, were willing to receive Denosumab, and met the inclusion/exclusion criteria. The first portion of the arm label indicates subjects' treatment groups (Placebo or Denosumab) in the parent study 20040138
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Denosumab 60 mg SC Q6M Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study | 186 |
| Denosumab/Denosumab 60 mg SC Q6M Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study | 198 |
| Total | 384 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative decision | 1 | 2 |
| Overall Study | Adverse Event | 5 | 9 |
| Overall Study | Consent withdrawn | 16 | 19 |
| Overall Study | Death | 11 | 13 |
| Overall Study | Disease progression | 3 | 3 |
| Overall Study | Investigator decision, or other reasons | 2 | 3 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Noncompliance | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo/Denosumab 60 mg SC Q6M | Denosumab/Denosumab 60 mg SC Q6M | Total |
|---|---|---|---|
| Age, Continuous | 73 Years STANDARD_DEVIATION 7.1 | 74.1 Years STANDARD_DEVIATION 6.6 | 73.6 Years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 26 Participants | 17 Participants | 43 Participants |
| Race/Ethnicity, Customized Japanese | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 153 Participants | 173 Participants | 326 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 186 Participants | 198 Participants | 384 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 185 | 46 / 199 |
| serious Total, serious adverse events | 45 / 185 | 51 / 199 |
Outcome results
Primary
Overall Survival Through Month 24
Time frame: 24 months
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/Denosumab 60 mg SC Q6M | Overall Survival Through Month 24 | 174 Participants |
| Denosumab/Denosumab 60 mg SC Q6M | Overall Survival Through Month 24 | 184 Participants |