The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
Percentage of Participants Maintaining Biochemical Castration
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Time frame: 6 months
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
Time frame: 12 months
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
Time frame: 6 and 12 months
Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
Time frame: Baseline and Month 12
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
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The Crouch Oak Family Practice
Addlestone, United Kingdom
Dr Carter & Partners
Ashford, United Kingdom
Westongrove Research Centre, Aston Clinton Surgery
Aylesbury, United Kingdom
Clinical Research Unit, Oldfield Surgery
Bath, United Kingdom
Clinical Research Unit, The Pulteney Practice
Bath, United Kingdom
St James' Surgery
Bath, United Kingdom
Waterloo Medical Centre
Blackpool, United Kingdom
Woolpit Health Centre
Bury St Edmunds, United Kingdom
Cossington House Surgery
Canterbury, United Kingdom
Research Office, Avondale Surgery
Chesterfield, United Kingdom
...and 25 more locations
Time frame: 6 and 12 month
Patient Satisfaction With Treatment.
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
Time frame: Month 12
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time frame: Month 12