2024-512023-37-00招募中2 期
A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomy
Ziekenhuis Aan De Stroom7 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 7
- 主要终点
- EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function)
研究概览
简要总结
To compare sexual function between the 2 treatment groups based on the EPIC-26 sexual domain at 9 months after start of hormonal treatment
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, > 18 years old
- •Serum albumin ≥3.0 g/dL
- •Serum creatinine <2.0 × upper limit of normal
- •Serum potassium ≥3.5 mmol/L
- •Serum total bilirubin ≤1.5 × ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
- •Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
- •Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
- •Patients who have received the information sheet and signed the informed consent form
- •Patients must be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Histologically confirmed adenocarcinoma of the prostate
- •Previous radical prostatectomy (RP), pT2-3, pN0 or pNx
- •PSA detectable with confirmed rise (at least 2 weeks apart) at least 8 weeks after RP
- •Hormone-naive disease
- •Patients amendable to take oral medication
- •Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
- •Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
排除标准
- •Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7)
- •Allergies, hypersensitivity or known intolerance to the study drugs or excipients.
- •History of any of the following: Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- •History of any of the following: Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
- •Current evidence of uncontrolled hypertension or gastrointestinal disorder affecting absorption
- •Patients already included in another clinical trial involving an experimental drug.
结局指标
主要结局
EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function)
EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function)
次要结局
- Quality of life will be assessed using EPIC-26 as well as the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and PR25 as well as FACT-P
- Acute as well as late toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (published November 27, 2017)
- Regarding efficacy, prostate-specific antigen (PSA) response rates, defined as a decline from baseline in PSA level of 80% or greater, as well as PSA complete response rates, defined as a decline from baseline in PSA level of 90% or greater, will be prospectively collected at the 4 treatment visits (i.e. at 0, 3, 6, and 9 months)
研究者
Clinical Trials Office
Scientific
Ziekenhuis Aan De Stroom
研究点 (7)
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