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The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.
Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteporosis Group | Active Comparator | Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD |
|
| Osteopenia Group | Active Comparator | Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD |
|
| Normal Group | Active Comparator | Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide and Calcium/ Vitamin D supplementation | Drug | Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Forearm bone mineral density | Over 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Fractures of the thoracolumbar spine | Over 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel J Parr, MBBS, FRCS(Urol), MD | Wirral University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wirral University Hospitals NHS Trust | Upton, Wirral | Merseyside | CH48 5PE | United Kingdom |
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| LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation | Drug | 3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily |
|
| LHRH agonists (Goserelin acetate) | Drug | 3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg) |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D002118 | Calcium |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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