Metastatic Prostate CancerNCT01233557
Biomarkers of Bone Resorption in Metastatic Prostate Cancer
An observational study of Metastatic Prostate Cancer, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men with hormone sensitive prostate cancer with bone metastases
Who may be able to join
- prostate cancer with bone metastases
- hormone sensitive
Who cannot join
- inadequate renal function
- ongoing dental problems
- previous bisphosphonate therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Biomarkers of Bone Resorption in Patients With Hormone Sensitive Bone Metastases From Prostate Cancer Treated With Antiandrogen Therapy and Bisphosphonates
Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.
- Conditions
- Metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bone Metastases | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Bissett, M.D., Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233557
- Sponsor's protocol ID
- 10/S0802/36
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2010
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Biomarkers of Bone Resorption in Patients With Hormone Sensitive Bone Metastases From Prostate Cancer Treated With Antiandrogen Therapy and Bisphosphonates
- ClinicalTrials.gov ID
- NCT01233557
- Acronym / sponsor ID
- 10/S0802/36
- Conditions
- Metastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Metastases | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men with hormone sensitive prostate cancer with bone metastases
Key inclusion criteria (2 listed)
- prostate cancer with bone metastases
- hormone sensitive
Key exclusion criteria (3 listed)
- inadequate renal function
- ongoing dental problems
- previous bisphosphonate therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Donald Bissett, M.D. principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer, run by University of Aberdeen at 1 site in United Kingdom.
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 3 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 5 Nov 2015.