Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGDecapeptyl® SR 22.5mg
22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
DRUGDecapeptyl® 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
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must give written (personally signed and dated) informed consent before completing any study related procedure. * Patients must be 18 years old or over. * Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment * Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL * Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests * Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value). In addition: * For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score \> 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline. * Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment.
Exclusion criteria
* Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions. * Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma. * Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy. * Patients scheduled to receive palliative radiotherapy during the course of the study. * Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy. * Patients receiving LHRH agonist as adjuvant to surgery. * Patients scheduled to undergo radical prostatectomy during the course of the study. * Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Biochemical Castration | 6 months | Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels | 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. | 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). |
| Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. | 12 months | Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation.. |
| Patient Satisfaction With Treatment. | 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 | Month 12 | — |
| Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Decapeptyl® SR 22.5mg Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days). | 14 |
| Current 3-monthly LHRH Agonist One 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 | 7 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Study termination | 9 | 6 |
Baseline characteristics
| Characteristic | Current 3-monthly LHRH Agonist | Total | Decapeptyl® SR 22.5mg |
|---|---|---|---|
| Age, Continuous | 78.7 years STANDARD_DEVIATION 9.3 | 77.7 years STANDARD_DEVIATION 6.7 | 77.2 years STANDARD_DEVIATION 5.4 |
| Employment status/Occupation Employed | 1 participants | 3 participants | 2 participants |
| Employment status/Occupation Retired | 6 participants | 18 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 21 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 14 | 7 / 7 |
| serious Total, serious adverse events | 2 / 14 | 0 / 7 |
Outcome results
Primary
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
Population: Analysis based on intent-to-treat (ITT) population comprised of 21 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decapeptyl® SR 22.5mg | Percentage of Participants Maintaining Biochemical Castration | 92.9 percentage of participants |
| Current 3-monthly LHRH Agonist | Percentage of Participants Maintaining Biochemical Castration | 100 percentage of participants |
Secondary
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.
Time frame: 6 and 12 month
Population: Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Effectiveness (n= 13, 7) | 3.2 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Effectiveness (n= 3, 2) | -33.3 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Side Effects (n= 13, 7) | -2.6 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Side Effects (n= 3, 2) | -25.0 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Convenience (n= 13, 7) | 4.7 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Convenience (n= 3, 2) | -1.9 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6months -Global Satisfaction(n= 12, 6) | -0.7 units on a scale |
| Decapeptyl® SR 22.5mg | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12months -Global Satisfaction(n= 2, 2) | -12.5 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12months -Global Satisfaction(n= 2, 2) | 4.2 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Effectiveness (n= 13, 7) | 13.1 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Convenience (n= 13, 7) | 2.0 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Effectiveness (n= 3, 2) | -12.5 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6months -Global Satisfaction(n= 12, 6) | -4.2 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 6 months - Side Effects (n= 13, 7) | 4.8 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Convenience (n= 3, 2) | 2.8 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) | Baseline to 12 months - Side Effects (n= 3, 2) | 12.5 units on a scale |
Secondary
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
Population: Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decapeptyl® SR 22.5mg | Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire. | 71.7 units on a scale |
| Current 3-monthly LHRH Agonist | Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire. | 70.0 units on a scale |
Secondary
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
Population: No participant analysis as no data was collected due to low number of participants recruited in the study.
Secondary
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
Population: Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Decapeptyl® SR 22.5mg | Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels | 6 months (n = 13, 7) | 84.6 percentage of participants |
| Decapeptyl® SR 22.5mg | Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels | 12 months (n = 2, 1) | 50 percentage of participants |
| Current 3-monthly LHRH Agonist | Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels | 6 months (n = 13, 7) | 100 percentage of participants |
| Current 3-monthly LHRH Agonist | Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels | 12 months (n = 2, 1) | 100 percentage of participants |
Secondary
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
Population: Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decapeptyl® SR 22.5mg | Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. | 22.2 percentage of participants |
| Current 3-monthly LHRH Agonist | Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. | 25.0 percentage of participants |
Secondary
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time frame: Month 12
Population: Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decapeptyl® SR 22.5mg | Percentage of Participants Who Changed Injection Frequency After Completion of the Study | 80 percentage of participants |
| Current 3-monthly LHRH Agonist | Percentage of Participants Who Changed Injection Frequency After Completion of the Study | 0 percentage of participants |