Assessment of Bone Loss in Men Receiving Treatment for Prostate Cancer

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