Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Hormones

Men with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT

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

Comprehensive bone health assessment

Janet E Brown, MBBS MD FRCP

Catherine Handforth, MBChB

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

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.

Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer

Assessed by HR-pQCT in the ADT group (Group A)and compared to the control group (Group C)

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer	NCT02785627	Prostate Cancer	Comprehensive b...	50 Years - 80 Years	University of Sheffield
Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer	NCT02785627	Prostate Cancer	Comprehensive b...	50 Years - 80 Years	University of Sheffield

Spots Global Cancer Trial Database for bone microarchitecture