EUCTR2012-004412-55-IT进行中（未招募）1 期
Cabazitaxel in relapsed high-risk HOrmone-SEnsitiveprostate cancer patients. A multicentric Randomized phase II study.C.HO.SE. Trial - C.HO.SE.
AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO0 个研究点目标入组 140 人开始时间: 2013年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •Patients meeting all of the following criteria will be considered for
- •enrollment into the
- •1. Pathologically confirmed adenocarcinoma of the prostate
- •2. Absence of distant metastasis at the diagnosis
- •3. Adequate radical treatment for prostate cancer: the following
- •treatments are
- •allowed for management of initial disease
- •· Radical prostatectomy
- •· External radical radiotherapy
- •· Interstitial brachytherapy
- •4. Biochemical failure after primary treatment with curative intent (as
- •2011 guideline definitions):
- •XML File Identifier: pgnqMWgEieDXnccenPA31nFWt5A=
- •· After RP: PSA level > 0.2 ng/ml with a second confirmation
- •· After EBRT: PSA level > 2 ng/ml above the nadir
- •· After IB: : PSA level > 2 ng/ml above the nadir
- •5. ADT for biochemical failure (all LHRH-A formulations and dosages are
- •allowed) according to the daily clinical practice
- •6. Failure to achieve PSA nadir value after 6 months with ADT: patients
- •receiving ADT are followed every two months and are evaluated after 6
- •months of treatment comparing the PSA value to the value which was
- •achieved at the nadir after radical treatment and before biochemical
- •progression. The patients could be classified according to three different
- •conditions:
- •· Good responders to ADT (6-month PSA is equal or less than PSA
- •nadir value)
- •· Partially responders to ADT (6-month PSA is lower than value before
- •ADT start but is greater than PSA nadir value)
- •· Non responders to ADT (6-month PSA is greater than PSA nadir value
- •or is increasing after a transient response)
- •For the purposes of the present study are eligible only the patients
- •7. ECOG Performance Status 0 or 1
- •8. Laboratory requirements at entry
- •EudraCT No.
- •C.HO.SE. Protocol, Version 1.1, July 2012
- •· Absolute neutrophils = 1.5 x 109/L
- •· Platelets = 100 x 109/L, Hemoglobin = 9 g/dl
- •· Serum creatinine <1.5 x ULN (If creatinine 1.0 - 1.5 x ULN, creatinine
- •clearance calculated according to CKD-EPI formula should be =60
- •· Serum bilirubin < 1 x UNL ASAT and ALAT < 2.5 UNL
- •9. Ability to fill the quality of life questionnaire
- •10. Obtained signed informed consent prior to start protocol specific
- •requirements
- •11. Patient compliance and geographic proximity that allow adequate
- •follow-up.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- 另有 1 项未显示
排除标准
- •Patients presenting with any of the following will not be included in the
- •1. Age > 75 years
- •2. Prior systemic chemotherapy
- •3. Prior complete androgen blockage
- •4. Prior ADT for the biochemical failure lasting more than 6 months
- •5. History of prior malignancies, except for cured non melanoma skin
- •other cancer curatively treated and with no evidence of disease for at
- •6. Significant neurological or psychiatric disorders such as dementia that
- •prohibit them to understanding or rendering informed consent or from
- •complying with treatment and follow-up
- •7. Other serious concomitant illness of medical conditions
- •8. Any other condition which in the judgment of the investigator would
- •subject at undue risk or interfere with the study.
研究者
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