EUCTR2010-019632-12-DE进行中（未招募）不适用
A phase II, multicentre, open, prospective, randomised, parallel-group, pharmacodynamic equivalence study on intramuscular versus subcutaneous applications of Triptorelin pamoate (Pamorelin® LA 11.25 mg) in patients with advanced prostate cancer - PAMIS
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- 性别
- Male
入选标准
- •(1) Provision of written informed consent prior to any study related procedures.
- •(2) Male patients aged 18 years and older
- •(3) Histologically or cytologically proven prostate cancer, locally advanced or
- •metastatic, or rising PSA after failed local therapy, and the patient scheduled to
- •receive androgen deprivation therapy
- •- Definition of locally advanced: T3 or T4 or N1 with any T, M09
- •- Definition of metastatic: any T, any N, M1
- •(4) Serum testosterone levels = 125 ng/dl (1.25 ng/ml, 1.25 ng/l, 4.3 nmol/l)
- •measured by any laboratory or on site within the previous 6 months or at study
- •(5) Karnofsky performance index > 70
- •(6) Expected survival = 9 months
- •(7) Absence of other malignancy, other than dermatological, for the previous 5 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •(1) Prior hormonal treatment for prostate cancer including finasteride, oestrogens or
- •a steroidal anti–androgen within the last 6 months preceding the study or
- •concomitant treatment with one or more of these substance(s)
- •(2) Prior hormonal treatment for prostate cancer including GnRH agonists or
- •antagonists within the last 12 months preceding the study or concomitant
- •treatment with one or more of these substance(s)
- •(3) Presence of another malignant neoplasm
- •(4) Prior hypophysectomy or adrenalectomy
- •(5) Patient who is scheduled to receive an orchiectomy during the course of this
- •(6) Any current use or within 6 months prior to treatment start of medications which
- •are known to affect the metabolism and/or secretion of androgenic hormones:
- •ketoconazole, aminoglutethimide, oestrogens and progesterone
- •(7) Use of corticosteroids, except topical applications
- •(8) Patient at risk of spinal cord compression or ureter obstruction
- •(9) Patient with abnormal baseline findings or any other medical condition(s) that, in
- •the opinion of the investigator, might jeopardise the subject’s safety or decrease
- •the chance of obtaining satisfactory data needed to achieve the objective(s) of
- •(10) Patient has a history of hypersensitivity to the IMP or drugs with a similar
- •chemical structure
- •(11) Inability to give informed consent or to comply fully with the protocol
- •(12) Participation in another clinical trial within the last 30 days or simultaneous
- •participation in another clinical trial
研究者
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