GP Extended Action Triptorelin

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Decapeptyl® SR 22.5mg
* Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decapeptyl® SR 22.5mg (Triptorelin)<br> | Drug: Decapeptyl® SR 22.5mg<br>* 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).<br>* Other names: Triptorelin;|
| Active Comparator: Current 3-monthly LHRH agonist<br>One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg | Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg<br>* 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<br>* Other names: Triptorelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Biochemical Castration | Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.. | 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. | 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). | 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. | 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. | Month 12 | 
| Percentage of Participants Who Changed Injection Frequency After Completion of the Study |  | Month 12 |