EUCTR2007-001703-38-DE进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS – AVODART after Radical Therapy for prostate cancer Study) - ARTS
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 276 人开始时间: 2008年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
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
- •Demographic and baseline characteristics:
- •1. Males <85 years of age
- •2. No clinically relevant abnormal findings on the screening ECG
- •Disease characteristics:
- •3. Patients with asymptomatic PSA failure following radical therapy with curative intent for clinically localised prostate cancer. PSA failure is defined as:
- •a. After primary radiotherapy:
- •i. 3 rises in PSA levels from nadir PSA, with each determination at least 4 weeks apart and a final PSA level =2 ng/mL above nadir PSA
- •ii. Time from radiotherapy should be at least 1 year from termination of radiotherapy treatment
- •b. After radical prostatectomy and salvage radiotherapy:
- •i. 3 rises in PSA level from nadir PSA, with each determination at least 4 weeks apart and each PSA level =0.2 ng/mL and a final PSA level =0.4 ng/mL (nadir PSA is defined as the lowest PSA value achieved after therapy)
- •4. Serum PSA levels:
- •a. =2 ng/mL and =20ng/mL for primary radiotherapy patients
- •b. =0.4 ng/ml and =10 ng/ml for radical prostatectomy and salvage radiotherapy patients
- •5. PSADT >3 months and =24 months
- •6. Clinical stage T1-T3a N0 M0
- •7. Non-metastatic prostate cancer, as confirmed on a negative bone scan performed within 6 months prior to the screening visit (Visit 1)
- •8. No evidence of local recurrence in radical prostatectomy or salvage radiotherapy patients
- •9. Expected survival =2 years
- •10. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Miscellaneous:
- •11. Able to swallow and retain oral medication
- •12. Able and willing to participate in the full 2 years of the study
- •13. Able to read and write (the MAX-PC questionnaire is self-administered), understand instructions related to study procedures and give written informed consent
- •14. In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
- •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
- •Demographic and baseline characteristics:
- •1. Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure or cerebrovascular accident within 6 months prior to Visit 1, or uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management
- •2. Abnormal liver function tests (greater than 2 times the upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST] or alkaline phosphatase [ALP] or >1.5 x ULN for bilirubin).
- •3. Serum creatinine >1.5 x ULN
- •4. History of another malignancy within 5 years that could affect the diagnosis of prostate cancer
- •5. History or current evidence of drug or alcohol abuse within 12 months prior to Visit 1
- •6. History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
- •7. Known hypersensitivity to any 5-AR inhibitor or to any drug chemically related to dutasteride
- •Disease characteristics:
- •8. Serum PSA levels
- •a. >20 ng/mL in primary radiotherapy patients
- •b. >10 ng/mL in radical prostatectomy and salvage radiotherapy patients
- •9. PSADT =3 months or >24 months
- •10. Biochemical failures in post brachytherapy patients
- •11. Clinical stage N+ or M+
- •12. Patient has previously been treated for prostate cancer with any of the following:
- •a. Chemotherapy
- •b. Oestrogens (e.g. megestrol, medroxyprogesterone, cyproterone, Diethylstilbestrol [DES])
- •c. Drugs with anti-androgenic properties (e.g. spironolactone if >50mg/day, flutamide, bicalutamide, ketoconazole, progestational agents) [Note: the use of topical ketoconazole is permitted prior to and during the study and the use of cimetidine is permitted prior to study entry]
- •d. GnRH analogues (e.g., leuprolide, goserelin) except when used for radiotherapy adjuvancy or neoadjuvancy (in this case use should have been for no more than 6 months and should have finalised at least 1 year before Visit 1)
- •e. Orchiectomy
- •Concomitant medications:
- •13. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to Visit 1 or during the study
- •14. Current and/or previous use of finasteride (Proscar, Propecia) or dutasteride (GI198745, AVODART™) exposure within 6 months prior to Visit 1
- •15. Anabolic steroids within 6 months prior to Visit 1
- •16. Participation in any other investigational or marketed drug trial within the 30 days prior to Visit 1 or any time during the study period
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