Prostate CancerANTELOPENCT02785627
Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer
An observational study of Prostate Cancer, run by Prof Janet Brown at 1 site in United Kingdom.
Trial summary
The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density, structure and strength over 12 months in men receiving treatment for prostate cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Comprehensive bone health assessment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Sep 2019
- 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men aged 50-80 years
Who may be able to join
- All participants
- Men aged 50-80 years old, WHO performance status ≤2.
- Have provided written informed consent prior to any trial-specific procedures
- Able and willing to comply with the terms of the protocol and to undertake the trial assessments
- Body Mass Index (kg/m2) >18.5 and <35.0
- No evidence of significantly abnormal organ function on standard laboratory testing
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- Group A
- Histological confirmation of prostate cancer
- No indication of metastatic disease
- Scheduled to commence ADT (but must have baseline assessments carried out within 4 weeks of commencement of ADT). Those starting ADT are expecting to have a duration of treatment of 12 months or more.
- No prior systemic therapy for advanced prostate cancer (not receiving concurrent anti-neoplastic therapy, besides ADT or an anti-androgens), participants may have received radiotherapy or may receive this during the study period
- Group B
- Men with newly diagnosed hormone sensitive metastatic prostate cancer who have commenced ADT and who have been referred for chemotherapy
- Bone metastases will be allowed provided not in the radius (DXA measurement will attempt to image sites with no/minimal bone metastases)
- Men who have received palliative radiotherapy for known bone metastases prior to or during the study may be included, but the site of radiotherapy must be accurately recorded and attempts will be made to avoid such sites in subsequent DXA measurement.
- Men with bone pain due to known bone metastases may receive necessary analgaesia, including opiates, as needed on study
- Participants in group B will be allowed to continue oral corticosteroids, provided that the dose does not exceed 2mg dexamethasone or 10 mg prednisolone daily. Men in this group may also receive additional steroids as prophylaxis during chemotherapy.
- Group C
- Men that do not have a diagnosis of prostate cancer
Who cannot join
- Known metabolic bone disease or other diseases (other than prostate cancer) known to affect bone metabolism including: hyperthyroidism, primary hyperparathyroidism, chronic liver disease, rheumatoid arthritis, inflammatory bowel disease or malabsorption
- Medications (in addition to ADT) known to affect bone metabolism including osteoporosis treatments and anti-epileptics
- Previous hormone treatments within 1 month (other than ADT in Groups A and B)
- Any concurrent or recent other invasive cancer that could confuse diagnosis or endpoints. Allowed situations include, but are not limited to, non-melanoma skin cancer, superficial bladder cancer (if in doubt please discuss with trial team).
- Fracture or orthopaedic surgery within the last 12 months
- Arthritis, orthopaedic surgery or other abnormality of the radius, spine or hip which would prevent accurate acquisition of study measurements.
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- Current or prior (within one month) participation in any other clinical trial involving a medicinal product, except STAMPEDE for men in group B. For other trial, please consult trial team.
- For Group B, those on bisphosphonates or alpha-radon on study entry are excluded (but please see separate advice on Pg 19 for men who need to go on bisphosphonates or alpha-radon whilst on study).
- Groups A and C: Men taking oral systemic corticosteroids (inhaled steroids will be permitted). In Group B oral corticosteroids are permitted, provided that the dose does not exceed 2mg dexamethasone or 10mg prednisolone daily. Those in group B may also receive additional steroids given as prophylaxis alongside chemotherapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cancer Clinical Trials Centre
Sheffield, South Yorkshire, S10 2SJ
Catherine Handforth, MBChB, 0114 2265202, c.handforth@sheffield.ac.uk
Janet E Brown, MBBS MD FRCP, j.e.brown@sheffield.ac.uk
About this study
The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density, structure and strength over 12 months in men receiving treatment for prostate cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months. Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total study length will be 3 years. The groups comprise:
Group A - Men with prostate cancer starting ADT
Read more
Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to start (or have started within the past 3 months) ADT and who will undergo chemotherapy with docetaxel and prednisolone
Group C - Age-matched men without prostate cancer
Read the detailed description
Prostate cancer is the commonest non-skin cancer in men, with more than 40,000 new cases diagnosed in the UK each year. Development of prostate cancer depends upon testosterone (the male hormone), and medications that block testosterone (eg Androgen Deprivation Therapy, ADT) can help men to survive for many years. Men with metastatic prostate cancer are also treated with ADT, but recent evidence has demonstrated that there are survival benefits when chemotherapy given as well as ADT. Many patients now receive chemotherapy as first line treatment along with ADT in the context of newly diagnosed metastatic disease.
However, blocking testosterone causes bone loss which may lead to osteoporosis and increases the risk of osteoporotic fracture. Such fractures cause pain, loss of mobility and independence, and one in three men who have a hip fracture will die within one year. The osteoporosis caused by prostate cancer treatments may differ from other forms; the limited available data suggest that it may affect the wrist more than other bones (most other forms affect the spine and hip the most). We need to better understand the pattern of osteoporosis in these men, so that we can offer the most effective treatment to protect their bones and ensure that they stay as well as possible as they live with their cancer treatment
The aim of this study is to determine the effect of prostate cancer treatment on bone health. Comprehensive bone assessment at baseline and 12 months will include different bone scans (DXA whole body, Xtreme CT of radius and HR CT T12 vertebra), biochemical markers of bone turnover, anthropometric measurements, and assessment of grip strength and muscle strength and function.
- Conditions
- Prostate Cancer
- Being tested
- Comprehensive bone health assessment
- Keywords
- Bone health, Bone microarchitecture, Androgen deprivation therapy (ADT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive bone health assessmentOther
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
| Study group | Role | What they receive |
|---|---|---|
| Group A: ADT | Men with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT Receives: Other: Comprehensive bone health assessment | |
| Group B: ADT + chemotherapy | Men with newly diagnosed hormone sensitive metastatic prostate cancer, starting ADT and who will have chemotherapy Receives: Other: Comprehensive bone health assessment | |
| Group C: Controls | Healthy age matched men Receives: Other: Comprehensive bone health assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volumetric bone mineral density at the distal radius
Assessed by HR-pQCT in the ADT group (Group A)and compared to the control group (Group C)
Measured: 12 months
Secondary outcomes (3)
Characterisation of the microstructural pattern of bone loss in men receiving treatments for prostate cancer.
This will be assessed by HR-pQCT of the distal radius, which gives detailed information regarding the bone volume ratio, trabecular number, derived trabecular thickness, derived trabecular separation, and volumetric bone mineral density. These will be compared in men receiving ADT/chemotherapy and compared with age-matched healthy controls and cortical thickness
Measured: 12 months
Correlation of bone loss and microstructural change with biochemical markers of bone turnover, serum testosterone levels and changes in muscle strength and body composition.
Determining whether bone loss and changes in bone microarchitecture are associated with changes in biomarkers of bone turnover measured in the serum, and changes in strength and body composition
Measured: 12 months
Characterisation of the microstructural pattern of bone loss at the spine (T12)
A comparison of bone loss and changes in bone microarchitecture at the T12 vertebra using HRCT in men receiving treatments for prostate cancer compared with age-matched, healthy controls
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Janet Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital Cancer Charity
- Responsible party
- Sponsor-investigator, Prof Janet Brown, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785627
- Sponsor's protocol ID
- STH18645
- Acronym
- ANTELOPE
- Status last verified
- May 2016
- First submitted
- 19 May 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02785627
- Acronym / sponsor ID
- ANTELOPE / STH18645
- Conditions
- Prostate Cancer
- Keywords
- Bone health, Bone microarchitecture, Androgen deprivation therapy (ADT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Prof Janet BrownUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital Cancer Charity
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 30 May 2016 (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.
The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density, structure and strength over 12 months in men receiving treatment for prostate cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months. Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total study length will be 3 years. The groups comprise:
Group A - Men with prostate cancer starting ADT
Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to start (or have started within the past 3 months) ADT and who will undergo chemotherapy with docetaxel and prednisolone
Group C - Age-matched men without prostate cancer
Detailed description
Prostate cancer is the commonest non-skin cancer in men, with more than 40,000 new cases diagnosed in the UK each year. Development of prostate cancer depends upon testosterone (the male hormone), and medications that block testosterone (eg Androgen Deprivation Therapy, ADT) can help men to survive for many years. Men with metastatic prostate cancer are also treated with ADT, but recent evidence has demonstrated that there are survival benefits when chemotherapy given as well as ADT. Many patients now receive chemotherapy as first line treatment along with ADT in the context of newly diagnosed metastatic disease.
However, blocking testosterone causes bone loss which may lead to osteoporosis and increases the risk of osteoporotic fracture. Such fractures cause pain, loss of mobility and independence, and one in three men who have a hip fracture will die within one year. The osteoporosis caused by prostate cancer treatments may differ from other forms; the limited available data suggest that it may affect the wrist more than other bones (most other forms affect the spine and hip the most). We need to better understand the pattern of osteoporosis in these men, so that we can offer the most effective treatment to protect their bones and ensure that they stay as well as possible as they live with their cancer treatment
The aim of this study is to determine the effect of prostate cancer treatment on bone health. Comprehensive bone assessment at baseline and 12 months will include different bone scans (DXA whole body, Xtreme CT of radius and HR CT T12 vertebra), biochemical markers of bone turnover, anthropometric measurements, and assessment of grip strength and muscle strength and function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: ADT | – | Other: Comprehensive bone health assessmentMen with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT |
| Group B: ADT + chemotherapy | – | Other: Comprehensive bone health assessmentMen with newly diagnosed hormone sensitive metastatic prostate cancer, starting ADT and who will have chemotherapy |
| Group C: Controls | – | Other: Comprehensive bone health assessmentHealthy age matched men |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men aged 50-80 years
Key inclusion criteria (19 listed)
- All participants
- Men aged 50-80 years old, WHO performance status ≤2.
- Have provided written informed consent prior to any trial-specific procedures
- Able and willing to comply with the terms of the protocol and to undertake the trial assessments
- Body Mass Index (kg/m2) >18.5 and <35.0
Key exclusion criteria (9 listed)
- Known metabolic bone disease or other diseases (other than prostate cancer) known to affect bone metabolism including: hyperthyroidism, primary hyperparathyroidism, chronic liver disease, rheumatoid arthritis, inflammatory bowel disease or malabsorption
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 |
|---|---|---|
| Comprehensive bone health assessmentBlood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius | Other | Group A: ADT, Group B: ADT + chemotherapy, Group C: Controls |
Primary outcome
Change in volumetric bone mineral density at the distal radius
Time frame: 12 months
Assessed by HR-pQCT in the ADT group (Group A)and compared to the control group (Group C)
3 secondary outcomes
Characterisation of the microstructural pattern of bone loss in men receiving treatments for prostate cancer.
Time frame: 12 months
Correlation of bone loss and microstructural change with biochemical markers of bone turnover, serum testosterone levels and changes in muscle strength and body composition.
Time frame: 12 months
Characterisation of the microstructural pattern of bone loss at the spine (T12)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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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.
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 Prostate Cancer, run by Prof Janet Brown 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 19 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janet E Brown, MBBS MD FRCP (0114-226-5202, j.e.brown@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volumetric bone mineral density at the distal radius (time frame: 12 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 30 May 2016.