EUCTR2020-003959-16-ES进行中（未招募）1 期
Phase III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging in patients with prostate cancer with rising PSA levels [biochemical recurrence (BCR)] (GuidePath) - GuidePath
ovartis Farmacéutica S.A.0 个研究点目标入组 190 人开始时间: 2021年8月20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
- 190
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
- •1. Signed informed consent must be obtained prior to participation in the study
- •2. Biopsy proven prostate adenocarcinoma.
- •3. Biochemical recurrence defined by American Urological Association (AUA) criteria for patients who have undergone radical prostatectomy (detectable or rising PSA value measured 6–13 wk after surgery, that is =0.2 ng/mL with a second determination of a PSA level>0.2 ng/mL at least 2 week apart) and by American Society for Radiation Oncology (ASTRO)-Phoenix criteria for patients who have undergone curative-intent radiotherapy (PSA=2 ng/mL above the nadir).
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •5. Participants must be adults = 18 years of age
- •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 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 133
排除标准
- •1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reasons (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
- •2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and Coronavirus Disease 2019 (COVID-19)
- •3. Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
- •4. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057, [68Ga]Ga-PSMA-11, or to CT contrast
- •5. Prior and current use of PSMA targeted therapies
- •6. Prior and current treatment with Luteinizing Hormone-Releasing Hormone (LHRH) analogues
- •7. Any prior ADT (first or second generation) within 9 months before screening
- •8. Any 5-alpha reductase inhibitors within 30 days before screening
- •9. Use of other investigational drugs within 30 days before screening
- •10. Castration-resistant patients
- •11. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
研究者
相似试验
进行中（未招募）
1 期
Diagnostic performance of [18F]CTT1057 PET in BCRProstate cancer with rising PSA levels [biochemical recurrence (BCR)]MedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003959-16-FRovartis Pharma AG190
进行中（未招募）
1 期
Diagnostic performance of [18F]CTT1057 PET versus pathologyEUCTR2020-003958-67-ITOVARTIS PHARMA AG195
进行中（未招募）
1 期
Diagnostic performance of [18F]CTT1057 PET versus pathologyntreated high risk prostate cancerMedDRA version: 21.0Level: PTClassification code 10036918Term: Prostate cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003958-67-ESovartis Farmacéutica, S.A.195
进行中（未招募）
1 期
Diagnostic performance of [18F]CTT1057 PET versus pathologyntreated high risk prostate cancerMedDRA version: 21.0Level: PTClassification code 10036918Term: Prostate cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003958-67-FRovartis Pharma AG195
已完成
不适用
Investigation and validation of the diagnostic performance of new biomarker candidates for (I) the early detection of an infectious origin of neutropenic fever and for the prediction of (II) an infection of patients after apoplectic stroke and the progression of (III) a nosocomial infection or (IV) a community acquired pneunomia to a severe sepsis/ septic shockA41.9Sepsis, unspecifiedDRKS00004159Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen1,018