Status:
COMPLETED
Study of Diagnostic Performance of [18F]CTT1057 in BCR
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE3
Brief Summary
The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in pati...
Detailed Description
This was a prospective, open-label, multi center, single-arm Phase III study to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA posi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study
- Biopsy proven prostate adenocarcinoma.
- Biochemical recurrence following initial definitive therapy (with either RP or curative intent radiation therapy) as defined:
- by AUA criteria (Cookson et al 2007) for patients who have undergone RP: Initial serum PSA of ≥0.2 ng/ml measured at least 6 weeks after RP with a second confirmatory persistent PSA level of \>0.2 ng/ml, or by ASTRO-Phoenix criteria (Roach et al 2006) for patients who have undergone curative-intent radiation therapy (RT): Rise of serum PSA measurement of 2 or more ng/mL above the nadir PSA observed post RT.
- ECOG performance status 0-2
- Participants must be adults ≥ 18 years of age
- Exclusion Criteria:
- 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.)
- 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
- Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
- Known allergy, hypersensitivity, or intolerance to \[18F\]CTT1057, \[68Ga\]Ga-PSMA-11, or to CT contrast
- Prior and current use of PSMA targeted therapies
- Prior ADT (first or second generation), including LHRH analogues (agonists or antagonists), within 9 months before screening
- Any 5-alpha reductase inhibitors within 30 days before screening
- Use of other investigational drugs within 30 days before screening
- Castration-resistant patients
- Patient with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
- Prior salvage surgery or salvage radiation therapy
Exclusion
Key Trial Info
Start Date :
September 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04838613
Start Date
September 30 2021
End Date
November 23 2023
Last Update
October 20 2025
Active Locations (13)
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1
Explorer Molecular Imaging center
Sacramento, California, United States, 95816
2
Novartis Investigative Site
Marseille, France, 13273
3
Novartis Investigative Site
Marseille, France, 13885
4
Novartis Investigative Site
Nîmes, France, 30029