Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer
NCT ID: NCT02785627
Last Updated: 2016-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
90 participants
OBSERVATIONAL
2016-09-30
2019-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A: ADT
Men with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT
Comprehensive bone health assessment
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
Comprehensive bone health assessment
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
Comprehensive bone health assessment
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comprehensive bone health assessment
Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
80 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Weston Park Hospital Cancer Charity
OTHER
Prof Janet Brown
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof Janet Brown
Professor of Translational Medical Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Clinical Trials Centre
Sheffield, South Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Catherine Handforth, MBChB
Role: primary
Janet E Brown, MBBS MD FRCP
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STH18645
Identifier Type: -
Identifier Source: org_study_id