To assess & compare the impact on disease control & patient & practitioner experience between the 6-monthly study drug & available 3-monthly injections. Comparison of the proportions of patients medically castrated & their PSA levels at 6 and 12 months between the 6-monthly study drug & 3-monthly injections. Review of patient satisfaction & preference for the 6-monthly study drug compared to 3-monthly injections & explore the effects of the 6-monthly study drug on the patients’ Quality of Life.
- Conditions
- locally advanced and metastatic prostrate cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004213-16-GB
- Lead Sponsor
- Ipsen Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method