An Open-Label, Multicenter, Phase III Study to Assess the Impact of Transient Androgenic Deprivation With Enantone LP 11.25 Mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Number of Participants With Negative Biopsies at Month 12
研究概览
简要总结
The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.
详细描述
The drug being tested in this study is called leuprorelin. Leuprorelin is being tested to treat people who have prostate cancer. Study assessments will include adverse events, prostatic-specific antigen (PSA) levels, and prostate biopsies.
The study will enroll approximately 120 patients. Participants will be randomly assigned (by chance, like flipping a coin) to a treatment group that will receive leuprorelin 11.25 mg (as one injection) or to an untreated observation group. Patients in the leuprorelin group will also receive bicalutamide 50 mg, a non-steroidal antiandrogen, once daily for 15 days to prevent a flare-up.
This multi-center trial will be conducted in France. The overall time to participate in this study is 12 months. After the screening visit, participants will make 6 visits to the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Is an out-patient 50 to 80 years old.
- •Has read, understood, signed and dated the informed consent.
- •Has indolent prostate cancer defined by:
- •Clinical Stage T1c or T2a.
- •Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of cores with tumor length > 3 mm.
- •Absence of Grade 4 cells (Gleason <7).
- •Prostate specific antigen (PSA) levels <10 ng/ml.
- •Has a life expectancy > 5 years.
- •Has accepted the principle of active surveillance.
- •Is willing to participate in the study for a minimum of fifteen months.
排除标准
- •Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or dutasteride) within the last 6 months.
- •Has psychological failure related to prostate cancer therapy.
- •Has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study.
- •Has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.
- •Is under judicial protection, tutorship or curatorship.
- •Is unlikely to attend control visits.
- •Is currently enrolled in an investigational study or has participated in another investigational study within the last 3 months.
- •Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP) 11.25 mg or Casodex® 50 mg.
- •Has a medical history of severely impaired hepatic function linked to bicalutamide or a pathological cause.
- •Has testosterone level < 0.5 ng/ml.
研究组 & 干预措施
Leuprorelin 11.25 mg
Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
干预措施: Leuprorelin (Drug)
Leuprorelin 11.25 mg
Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days.
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Number of Participants With Negative Biopsies at Month 12
时间窗: Month 12
Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy \[presence of positive cores, the absence of core with tumor length \> 3 millimeters (mm), and absence Grade 4 cells (Gleason score \< 7)\]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.
次要结局
- Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score(Baseline and Months 3, 6, 9 and 12)
- Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)(Baseline and Month 12)
- Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI(Baseline and Month 12)
- Change From Baseline in Prostate-specific Antigen (PSA) Levels(Baseline and Months 3, 6, 9 and 12)
- Number of Participants With Gleason Score ≥ 7(Month 12)
- Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score(Baseline and Months 3, 6, 9 and 12)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score(Baseline and Months 3, 6, 9 and 12)