Phase II/III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging for the detection of PSMA positive tumors using histopathology as a standard of truth (GuideView) - GuideView

ovartis Farmacéutica, S.A.0 个研究点目标入组 195 人开始时间: 2021年8月20日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•1. Untreated high risk biopsy-proven PCa patients according to D’Amico classification (Stage T2c or PSA level >20ng/ml or Gleason score =8)
•2. Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
•3. ECOG performance status 0-2
•4. Signed informed consent must be obtained prior to participation in the study
•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 58
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 137

•1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (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 COVID-19.
•3. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
•4. Prior and current use of PSMA targeted therapies
•5. Prior and current treatment with LHRH analogues
•6. Any prior ADT (first or second generation) within 9 months before screening
•7. Any 5-alpha reductase inhibitors within 30 days before screening
•8. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
•9. Patients with incidental PCa after transuretheral resection
•10. Use of other investigational drugs within 30 days before screening

发起方

ovartis Farmacéutica, S.A.