GP Extended Action Triptorelin
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01673984
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 27
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decapeptyl® SR 22.5mg (Triptorelin) Decapeptyl® SR 22.5mg - Current 3-monthly LHRH agonist Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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..
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.
Percentage of Participants Who Changed Injection Frequency After Completion of the Study Month 12 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.
Trial Locations
- Locations (35)
Danes Camp Surgery
🇬🇧Northampton, United Kingdom
The Porch Surgery
🇬🇧Corsham, United Kingdom
Waterloo Medical Centre
🇬🇧Blackpool, United Kingdom
St James' Surgery
🇬🇧Bath, United Kingdom
Dr Carter & Partners
🇬🇧Ashford, United Kingdom
Westongrove Research Centre, Aston Clinton Surgery
🇬🇧Aylesbury, United Kingdom
The Medical Centre
🇬🇧East Horsley, United Kingdom
The Crouch Oak Family Practice
🇬🇧Addlestone, United Kingdom
Woolpit Health Centre
🇬🇧Bury St. Edmunds, United Kingdom
Cossington House Surgery
🇬🇧Canterbury, United Kingdom
Sherbourne Medical Centre
🇬🇧Leamington Spa, United Kingdom
Clinical Research Unit, The Pulteney Practice
🇬🇧Bath, United Kingdom
Ashfields Primary Care Centre
🇬🇧Sandbach, United Kingdom
Cape Cornwall Surgery
🇬🇧Penzance, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
The Rame Group Practice
🇬🇧Plymouth, United Kingdom
Brannel Surgery
🇬🇧St Austell, United Kingdom
Albany House Medical Centre
🇬🇧Wellingborough, United Kingdom
Woosehill Medical Centre
🇬🇧Wokingham, United Kingdom
Clinical Research Unit, Oldfield Surgery
🇬🇧Bath, United Kingdom
Research Office, Avondale Surgery
🇬🇧Chesterfield, United Kingdom
Clinical Research Dept., Rowden Surgery
🇬🇧Chippenham, United Kingdom
Clinical Research Unit, Hathaway Medical Centre
🇬🇧Chippenham, United Kingdom
Pound Hill Surgery
🇬🇧Crawley, United Kingdom
Kingsthorpe Medical Centre
🇬🇧Northampton, United Kingdom
Burbage Surgery
🇬🇧Hinckley, United Kingdom
The Portmill Surgery
🇬🇧Hitchin, United Kingdom
Mortimer Surgery
🇬🇧Mortimer Common, United Kingdom
Kiltearn Medical Centre
🇬🇧Nantwich, United Kingdom
Wansford & Kings Cliffe Practice, Wansford Surgery
🇬🇧Peterborough, United Kingdom
Sunbury Health Centre Group Practice
🇬🇧Sunbury-on-Thames, United Kingdom
Adcroft Surgery
🇬🇧Trowbridge, United Kingdom
Sheepcot Medical Centre
🇬🇧Watford, United Kingdom
Townhead Surgery
🇬🇧Irvine, United Kingdom
The Alverton Practice
🇬🇧Penzance, United Kingdom