| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| locally advanced and metastatic prostrate cancer |
|
| E.1.1.1 | Medical condition in easily understood language |
| advanced prostrate cancer |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Primary Study Objective
The primary objective of this study is to demonstrate non-inferiority of Decapeptyl SR 22.5mg to a standard 3-monthly LHRH agonist in maintaining biochemical castration (testosterone levels ≤0.5ng/mL) after 6 months’ treatment. |
|
| E.2.2 | Secondary objectives of the trial |
Disease control variables
• Compare the percentage of patients with stable, advanced prostate cancer who maintain biochemical castration (testosterone levels ≤0.5ng/mL) after 12 months’ treatment with study drug v a standard 3-monthly LHRH agonist
• Assess the proportion of patients demonstrating stable PSA levels compared to Baseline at 6 & 12 months in each treatment arm
- Quality of life variables
• Assess the Quality of Life using the EQ-5D-5L at Baseline & 12 months or, where applicable, study withdrawal in each treatment arm
• Assess patient satisfaction with medication using the Treatment Satisfaction Questionnaire for Medication (TSQM Version II) following treatment at 6 & 12 months in each treatment arm
• Assess patient satisfaction with treatment using a study-specific questionnaire
• Assess proportion of patients who change injection formulation on completion of the study.
- Safety variables
• Collect safety data throughout study duration. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Inclusion criteria:
All patients must fulfil the following:
• 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 (confirmed by hospital/consultant’s letter).
Patients receiving an LHRH agonist to manage rising PSA levels post-radical treatment can be included provided the
other specified inclusion and exclusion criteria are met.
• Patients must be medically castrated with serum testosterone ≤0.5ng/mL (confirmed at Screening and Baseline Visits by
central laboratory analysis).
• Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the Screening tests (this can include the injection coinciding with the Screening visit).
• 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. |
|
| E.4 | Principal exclusion criteria |
Exclusion criteria:
Patients will not be included in the study if:
• Patients have had previous surgical castration. Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, 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 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.
• 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. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Disease Control Endpoint
The primary endpoint is the difference in the percentage of patients who maintain biochemical castration between the two treatment arms after 6 months of treatment.
A difference of less than 7.5% is considered to be not clinically relevant. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Endpoint: Difference in the percentage of patients who maintain biochemical castration after 6 months of treatment. |
|
| E.5.2 | Secondary end point(s) |
Secondary Disease Control Endpoints
• The difference in the percentage of patients who maintain biochemical castration between the two treatment arms after 12 months of treatment
• The proportion of patients demonstrating stable PSA levels after 6 and 12 months of treatment
Quality of Life Endpoints
• Assessment of patient Quality of life using EQ-5D-5L at Baseline and Month 12
• Assessment of patient satisfaction with medication using TSQM (Version II) at Baseline, Month 6 and Month 12
• Assessment of patient satisfaction with treatment at Month 12
• The percentage of patients who change their injection frequency at the completion of the study
Safety Endpoints
Safety will be assessed throughout the study duration. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoint: Difference in the percentage of patients who maintain biochemical castration after 12 months of treatment.
Endpoint: Proportion of patients demonstrating stable PSA levels after 6 and 12 months of treatment.
Endpoint: Assessment of patient Quality of life using EQ-5D-5L at Baseline and after 12 months of treatment.
Endpoint: Assessment of patient satisfaction with medication using TSQM (version II) at Baseline and after 6 and 12 months of treatment.
Endpoint: Percentage of patients who change injection frequency at the completion of the study.
Safety:AEs will be monitored from the time that the patient gives informed consent to the end of the study.
end of the study ( |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
The study will also aim to confirm the practicality as well as a preference by both physicians and patients alike, for a 6-monthly injection.
(Quality of life and patient satisfaction for medicine questionnaires.)
|
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 34 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| For notification to the competent authority, the study will be considered to have finished (“End of study”) when the last patient has completed the last study visit |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 27 |
| E.8.9.1 | In the Member State concerned days | 0 |
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