A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Achievement of Castration and Maintenance of Castration
研究概览
简要总结
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone.
详细描述
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven prostate cancer.
- •The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.
- •Serum testosterone levels >5 nmol/L.
- •Karnofsky performance index >
- •Expected survival > 18 months.
- •Absence of another malignancy, other than local dermatological, for the previous 5 years.
- •Signed informed consent before entry into the study.
排除标准
- •Prior hormonal treatment for prostate cancer within 6 months prior to study start.
- •Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
- •Presence of another neoplastic lesion or brain metastases.
- •Prior hypophysectomy or adrenalectomy.
- •Known or suspicion of vertebral metastases with risk of spinal compression.
- •Severe kidney or liver failure (creatinine > 2 times the upper normal limit, ASAT and ALAT >3 times the upper normal limit).
- •Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.
- •Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
- •Known hypersensitivity to any of the test materials or related compounds.
- •Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.
- •Any current use or use 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.
- •Use of systemic or inhaled corticosteroids (topical application permitted).
- •Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted).
- •Inability to give Informed Consent or to comply fully with the protocol.
研究组 & 干预措施
Triptorelin
干预措施: triptorelin embonate (INN) (Drug)
结局指标
主要结局
Achievement of Castration and Maintenance of Castration
时间窗: at Day 29
Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
次要结局
- LH Increase(day 1 and day 169)