EUCTR2011-004213-16-GB进行中（未招募）1 期
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 - GP Randomised Extended Action Triptorelin (GREAT study)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Ltd
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
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