Percentage of Participants Maintaining Biochemical Castration
| Group | Value (percentage of participants) |
|---|---|
| Decapeptyl® SR 22.5mg | 92.9 |
| Current 3-monthly LHRH Agonist | 100 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataShort name GREAT
This trial was stopped early.
Reason given at the registry: The study was discontinued prematurely by the sponsor due to non-medical reasons
Results were posted for this trial.
United Kingdom
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Decapeptyl® SR 22.5mg (Triptorelin)
Active comparator
Current 3-monthly LHRH agonist
One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Outcomes the sponsor listed as primary.
Percentage of Participants Maintaining Biochemical Castration
Time frame · 6 months
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
Time frame · 12 months
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
Time frame · 6 and 12 months
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.
Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
Time frame · Baseline and Month 12
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).
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Time frame · 6 and 12 month
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.
Patient Satisfaction With Treatment.
Time frame · Month 12
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time frame · Month 12
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Decapeptyl® SR 22.5mg | 92.9 |
| Current 3-monthly LHRH Agonist | 100 |
| Group | Value (percentage of participants) |
|---|---|
| Decapeptyl® SR 22.5mg | 22.2 |
| Current 3-monthly LHRH Agonist | 25.0 |
| Group | Value (percentage of participants) |
|---|---|
| Decapeptyl® SR 22.5mg | 84.6 |
| Current 3-monthly LHRH Agonist | 100 |
| Group | Value (units on a scale) |
|---|---|
| Decapeptyl® SR 22.5mg | 71.7 |
| Current 3-monthly LHRH Agonist | 70.0 |
| Group | Value (units on a scale) |
|---|---|
| Decapeptyl® SR 22.5mg | 3.2 |
| Current 3-monthly LHRH Agonist | 13.1 |
| Group | Value |
|---|---|
| Decapeptyl® SR 22.5mg | not posted |
| Current 3-monthly LHRH Agonist | not posted |
| Group | Value (percentage of participants) |
|---|---|
| Decapeptyl® SR 22.5mg | 80 |
| Current 3-monthly LHRH Agonist | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Decapeptyl® SR 22.5mgDecapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days). | – | 2 / 14 | 12 / 14 |
| Current 3-monthly LHRH AgonistOne of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: 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 | – | 0 / 7 | 7 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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Who could join, as posted.
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