Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Bicalutamide and Calcium/ Vitamin D supplementation
* Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation
* Drug: LHRH agonists (Goserelin acetate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated Exclusion Criteria: Previous systemic therapy for prostate cancer Patients with any illness or medication that would affect bone and mineral metabolism Severe hepatic or renal insufficiency
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osteporosis Group<br>Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD | Drug: Bicalutamide and Calcium/ Vitamin D supplementation<br>* Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily<br>|
| Active Comparator: Osteopenia Group<br>Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD | Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation<br>* 3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily<br>|
| Active Comparator: Normal Group<br>Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists | Drug: LHRH agonists (Goserelin acetate)<br>* 3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Forearm bone mineral density |  | Over 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractures of the thoracolumbar spine |  | Over 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, bone density, osteoporosis, androgen antagonists