Study of Diagnostic Performance of [18F]CTT1057 in BCR

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