A Study to Assess the Effect of changing testosterone levels on quality of life and physiology in men with prostate cancer undergoing hormone therapy
- Conditions
- Prostate cancerCancer - Prostate
- Registration Number
- ACTRN12608000170325
- Lead Sponsor
- Abbott pharmaceuticals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 250
Prostate cancer requiring commencement of androgen suppression, and likely to be a candidate for an intermittant program.
Prior treatment with hormonal therapy, chemotherapy or biologic response modifiers (other than neoadjuvant hormonal therapy that meets the criteria of 3.1.(i)
b) Patients presenting with acute or impending cord compression.
c) Patients with extensive involvement manifest by a report of ‘superscan’ type uptake pattern.
d) History of prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, or other cancer for which the patient has been disease-free for at least 5 years.
e) Patients with known history of hypersensitivity reaction to either study medication or drugs with a similar structure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) + Prostate Module and physiological measures: Full blood count, serum lipids, waist and hip measures, weight, bone turnover markers, Dual Energy X-ray Absorptiometry (DEXA) bone densitometry, fat assessment from DEXA scan, muscle strength by timed stands, lean mass from DEXA scan, Blood pressure (BP), and pulse.[Descriptive observational study over 3 years, with assessment 3 monthly. Effect on quality of life at each time point, with BP, weight, hip and waist measures, weight, timed stands, disease activity measured at each time point, DEXA scan assessments at baseline, end of treatment phase (9 months) then at 1 and 2 yeasr after. Bone activity measures at baseline, during treatement and post treatment period.]
- Secondary Outcome Measures
Name Time Method one.[None.]