NCT00801242已完成3 期
An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 51
- 主要终点
- Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment
研究概览
简要总结
The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.
详细描述
The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA >4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- •Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment.
- •Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL.
- •Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be <24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL.
- •Is a male patient aged 18 years or older.
- •Has an Eastern Cooperative Oncology Group score of ≤
- •Has a life expectancy of at least 24 months.
排除标准
- •Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit.
- •Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
- •Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Has hypersensitivity towards any component of the investigational medicinal product.
- •Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- •Has a known or suspected clinically significant liver and/or biliary disease.
- •Has a history of or risk factors for Torsades de Pointes
- •At time of inclusion receives concomitant medications that might prolong the QT interval.
- •Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial.
- •Has a clinically significant disorder (other than prostate cancer) including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the investigator.
- •Has severe kidney failure (creatinine clearance <30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France).
- •Has a mental incapacity or language barriers precluding adequate understanding or co operation.
- •Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial.
- •Has previously participated in any degarelix trial
研究组 & 干预措施
Degarelix 240 mg / 80 mg
Experimental
干预措施: Degarelix 240 mg / 80 mg (Drug)
结局指标
主要结局
Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment
时间窗: Up to 24 months after end of induction period
Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.
次要结局
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment(Up to 3 x 31 months)
- Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment(Up to 24 months after end of induction period)
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment(Up to 3 x 31 months)
- Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD(7 months)
- Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD(Up to 31 months)
- Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD(7 months)
- Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD(Up to 31 months)
研究者
研究点 (51)
Loading locations...
相似试验
终止
2 期
Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 PatientsCOVID-19NCT04573153ScandiBio Therapeutics AB100
已完成
不适用
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced HypothermiaAnesthesia Induced HypothermiaInadvertent Perioperative HypothermiaNCT01900067Molnlycke Health Care AB271
已完成
3 期
Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and VietnamMalaria, FalciparumNCT03355664University of Oxford310
已完成
不适用
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg UlcersVenous Leg UlcerNCT03589586LifeNet Health100
Unknown
不适用
Effectiveness and Safety of Rhea Health Tone® as add-on Therapy for COVID-19 in Hospitalized Adults in IndonesiaCovid19NCT04627519Universitas Padjadjaran85