CancerPhase 3NCT00838201
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
A Phase 3 study testing Denosumab in people with Cancer and Carcinoma, run by Amgen at 74 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer
- What is being tested?
- Denosumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 74 sitesin 6 countries
- Study dates
- 1 Feb 2009to 3 May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be currently participating in the 20040138 Amgen study
- Subjects must sign the informed consent before any study specific procedures are performed.
Who cannot join
- 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
Trial locations and contacts
74 sites in 6 countries.
74 sites in 6 countries
United States27 sites
Research Site
Albany, New York, 12208
Research Site
Anaheim, California, 92801
Research Site
Bay Shore, New York, 11706
Research Site
Burien, Washington, 98166
Research Site
Dallas, Texas, 75231
Research Site
East Providence, Rhode Island, 02914
Research Site
Fort Wayne, Indiana, 46825
Research Site
Garden City, New York, 11530
Research Site
Greenbelt, Maryland, 20770
Research Site
Huntsville, Alabama, 35801
Research Site
Laguna Hills, California, 92653
Research Site
Lancaster, Pennsylvania, 17604
Research Site
Long Beach, California, 90813
Research Site
Middlebury, Connecticut, 06762
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
New Britain, Connecticut, 06052
Research Site
Omaha, Nebraska, 68114
Research Site
Poughkeepsie, New York, 12601
Research Site
Salem, Virginia, 24153
Research Site
San Bernardino, California, 92404
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92120
Research Site
Santa Monica, California, 90404
Research Site
Sartell, Minnesota, 56377
Research Site
Seattle, Washington, 98104
Research Site
Tacoma, Washington, 98405
Research Site
Trinity, Florida, 34655
Canada27 sites
Research Site
Barrie, Ontario, L4M 7G1
Research Site
Brantford, Ontario, N3R 4N3
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Burlington, Ontario, L7S 1V2
Research Site
Calgary, Alberta, T2V 1P9
Research Site
Greater Sudbury, Ontario, P3E 4T3
Research Site
Greenfield Park, Quebec, J4V 2H3
Research Site
Guelph, Ontario, N1H 5J1
Research Site
Kelowna, British Columbia, V1Y 2H4
Research Site
Kingston, Ontario, K7L 3J7
Research Site
Kitchener, Ontario, N2N 2B9
Research Site
London, Ontario, N6A 4G5
Research Site
Markham, Ontario, L6B 1A1
Research Site
Montreal, Quebec, H3G 1A4
Research Site
Newmarket, Ontario, L3X 1W1
Research Site
North Bay, Ontario, P1B 7K8
Research Site
North York, Ontario, M2J 1V1
Research Site
Oakville, Ontario, L6H 3P1
Research Site
Oshawa, Ontario, L1H 7K4
Research Site
Scarborough Village, Ontario, M1P 2T7
Research Site
Surrey, British Columbia, V3V 1N1
Research Site
Toronto, Ontario, M2J 1V1
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M6A 3B5
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Victoria, British Columbia, V8T 5G1
Research Site
Victoria, British Columbia, V8V 3N1
Poland9 sites
Research Site
Bialystok, 15-276
Research Site
Bydgoszcz, 85-171
Research Site
Lublin, 20-718
Research Site
Lublin, 20-954
Research Site
Opole, 45-086
Research Site
Siedlce, 08-110
Research Site
Warsaw, 00-416
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 50-088
Hungary5 sites
Research Site
Balatonfüred, 8230
Research Site
Budapest, 1036
Research Site
Budapest, 1204
Research Site
Győr, 9023
Research Site
Nyíregyháza, 4400
Mexico4 sites
Research Site
Mexico City, Distrito F, 07760
Research Site
Mexico City, Distrito F, 14140
Research Site
Toluca, 50120
Research Site
Veracruz, 91700
About this study
Official title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
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.
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors
- Being tested
- Denosumab
- Keywords
- Androgen deprivation therapy for non-metastatic prostate cancer
- Medical subject headings
- Neoplasms, Carcinoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Through Month 24
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study start1 Feb 2009
- Primary completion3 May 2012
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838201
- Sponsor's protocol ID
- 20080537
- Status last verified
- Sep 2018
- First submitted
- 5 Feb 2009
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00838201
- Acronym / sponsor ID
- 20080537
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors
- Keywords
- Androgen deprivation therapy for non-metastatic prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 3 May 2012 (actual)
- Study completion
- 3 May 2012 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Posted 24 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Denosumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be currently participating in the 20040138 Amgen study
- Subjects must sign the informed consent before any study specific procedures are performed.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18 | Drug | Arm 1 |
Primary outcome
Overall Survival Through Month 24
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
74 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Cancer and Carcinoma, run by Amgen at 74 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada, Poland, Hungary, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Through Month 24 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.