- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785627
Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer (ANTELOPE)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Janet E Brown, MBBS MD FRCP
- Phone Number: 0114-226-5202
- Email: j.e.brown@sheffield.ac.uk
Study Contact Backup
- Name: Catherine Handforth, MBChB
- Phone Number: 0114-226-5202
- Email: c.handforth@sheffield.ac.uk
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
- Cancer Clinical Trials Centre
-
Contact:
- Catherine Handforth, MBChB
- Phone Number: 0114 2265202
- Email: c.handforth@sheffield.ac.uk
-
Contact:
- Janet E Brown, MBBS MD FRCP
- Email: j.e.brown@sheffield.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
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
Exclusion Criteria:
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.
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A: ADT
Men with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT
|
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
|
Group B: ADT + chemotherapy
Men with newly diagnosed hormone sensitive metastatic prostate cancer, starting ADT and who will have chemotherapy
|
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
|
Group C: Controls
Healthy age matched men
|
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterisation of the microstructural pattern of bone loss in men receiving treatments for prostate cancer.
Time Frame: 12 months
|
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
|
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
|
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
|
12 months
|
Characterisation of the microstructural pattern of bone loss at the spine (T12)
Time Frame: 12 months
|
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
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH18645
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Comprehensive bone health assessment
-
M.D. Anderson Cancer CenterActive, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Istituto Ortopedico RizzoliCompletedFrail Elderly SyndromeItaly
-
Göteborg UniversityUmeå UniversityCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiMinistry of Health, ItalyRecruitingFrailty | AgeingItaly
-
University of PalermoCharles University, Czech Republic; Erasmus University Rotterdam; Ente Ospedaliero... and other collaboratorsNot yet recruitingOsteo Arthritis Knee
-
Region SkaneCompleted
-
Uppsala UniversitySwedish Council for Working Life and Social ResearchRecruitingAttention Deficit Hyperactivity DisorderSweden
-
Odense University HospitalRecruitingNon-small Cell Lung Cancer | Stereotactic Body Radiotherapy | Comprehensive Geriatric AssessmentDenmark
-
University Hospital, ToulouseInstitut Claudius RegaudRecruitingLymphoma | Neoplasm, Plasma CellFrance
-
Gulhane Training and Research HospitalProvincial Health Services AuthorityEnrolling by invitationDepression | Malnutrition | Dementia | Frailty | Drug Use | Old Age; DebilityTurkey