EUCTR2017-001395-38-IT进行中（未招募）1 期
Treatment of Metastatic prostate cancer castration resistant (mCRPC) with 223RaCl2: response evaluation with a novel tracer 68Ga-PSMA PET molecular imaging - CALIPSO
AZIENDA USL DELLA VALLE D'AOSTA0 个研究点目标入组 50 人开始时间: 2020年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigational nature of study
- •3.Histologically or cytologically confirmed adenocarcinoma of the prostate
- •4.Known hormone refractory disease (castrate serum testosterone level: =50 ng/dL)
- •5.Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within 4 weeks
- •6.Bone pain (Brief Pain Inventory BPI-SF = 2 )
- •7.ECOG Performance status (PS): 0-2
- •8.Acceptable haematology and serum biochemistry screening values as follows: WBC= 3000/mm3 , ANC= 1500/mm3, PLT= 100000/mm3 , Hb= 10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine <1.5 x the upper limit of normal
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc) or to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)
- •2.Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI
- •3.Visceral metastases assessed by thorax and abdominal/pelvic CT within previous 8 weeks
- •4.Malignant lymphoadenopathy exceeding 3 cm in short axis diameter assessed by thorax and abdominal/pelvic CT within previous 8 weeks
- •5.Patients with known inflammatory bowel disease (IBD)
- •6.Patients with known osteonecrosis of the jaw (ONJ)
- •7.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug
- •8.Concomitant chemotherapy, abiraterone or enzalutamide therapy
研究者
相似试验
招募中
2 期
Treatment of patients with castration-resistant metastatic prostate cancer with nuclear medicine procedureCastration resistant metastatic prostate cancer.Malignant neoplasm of prostateIRCT20180113038331N1Mashhad University of Medical Sciences20
已完成
1 期
Radionuclide therapy using Lutetium-177 prostate specific membrane antigen (PSMA): a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)Cancer - ProstateProstate CancerACTRN12615000912583Peter MacCallum Cancer Centre30
已完成
不适用
Transmurale zorg Prostaatkanker, van diagnose tot en met nazorgProstate cancer, transmural care, decision aid, SDM, Follow-up care, Substitution, Family doctors or General practitioners, Prostaatkanker, Keuzehulp, Samenwerking tussen eerste lijn en tweede lijn.NL-OMON22953Initiator: Catharina Wilhelmina Hospital (CWZ)NijmegenPrimary Sponsor/Performer: Radboud University Nijmegen Medical centerOther performers: CWZ in Nijmegen, Maashospital Pantein in Boxmeer200
进行中（未招募）
1 期
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug EfficacyProstate CancerEUCTR2004-000193-31-GBniversity College London12,000
进行中（未招募）
1 期
Treatment Of Metastatic Bladder cancer at the time Of biochemical reLApse following radical cystectomy - TOMBOLArothelial cancerCTIS2024-510865-41-00Aarhus Universitetshospital282