EUCTR2009-012076-26-GR进行中（未招募）1 期
A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 760
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
- •Men = 30 of age with non-metastatic prostate cancer
- •Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months
- •ECOG score (0, 1, or 2)
- •Baseline BCVA of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS charts at 4 meters in one eye with a natural, intact lens
- •Bone Mineral Density (BMD) requirements:
- •If < 70 years: BMD T-score at the lumbar spine, total hip, or femoral neck = -2.5 and = -1.0 (osteopenia”; at least one site required).
- •If = 70 years: BMD T-score at lumbar spine and total hip and femoral neck = -2.5
- •At least 2 evaluable lumbar vertebrae
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Screening LOCS III grade of = 3.5 for P, = 4.0 for C, or = 4.5 for NO
- •Bone Mineral Density (BMD) T-score < -2.5 at lumbar spine and/or total hip and/or femoral neck (osteoporosis”)
- •Known history of prior fragility fracture (fractures associated with no or minimal trauma severity [eg, fall from standing height])
- •Evidence of distant metastases
- •Diagnosis of any secondary non-prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin cancer
- •Known HIV, HCV, or Hepatitis B Infection
- •Known osteonecrosis of the jaw (ONJ)
- •Current hyper-or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range)
- •Paget’s disease, Cushing’s disease, hyperprolactinemia, chronic liver disease or rheumatoid arthritis
- •Dialysis or expected to undergo dialysis within 1 year
- •Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization
- •Major surgery, or significant traumatic injury occurring within 4 weeks before randomization
- •Incisional eye surgery in both eyes or cataract surgery in both eyes
- •Ocular disease leading to visual loss (eg, macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult.
- •Planned cataract surgery or major visual disturbance expected to result in need for cataract surgery within one year
- •Concurrent systemic anti-neoplastic therapy or radiotherapy, other than ADT and/or anti-androgen therapy
- •Current administration of IV bisphosphonates (oral bisphosphonates allowable if they are stopped at study entry)
- •Concurrent use of anti-glaucoma medications
- •Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy including ophthalmologic steroid use (topical, inhaled, or nasal steroids are allowed)
- •Incapable of being responsive to midriatic agents (minimum of approximately a 6 mm pupil required)
- •Prior administration of denosumab
- •PSA > 5 ng/mL at screening
- •Serum calcium or albumin-adjusted serum calcium levels < 2.0 mmol/L (8.0 mg/dL), or = 2.9 mmol/L (11.5 mg/dL)
- •25-hydroxyvitamin D deficiency (< 20 ng/mL)
- •Not willing to use 2 highly effective methods of contraception during treatment and for 10 months after the end of treatment
- •Subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
- •Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device. Subjects in the observational phase of clinical studies (eg, to collect survival data) are allowed
- •Organic or psychiatric disorder which, in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results
研究者
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