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

Completed · Phase 3

Conditions studied: Prostatic Neoplasms, Prostate Cancer, Recurrence

In brief

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 patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable \[18F\]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.

Key facts

Study ID

NCT04838613

Run by

Novartis Pharmaceuticals

People needed

190

Starts

2021-09-30

Expected to finish

2023-11-23

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Explorer Molecular Imaging center — Sacramento, California, United States
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Nîmes, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Saint-Priest-en-Jarez, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Valencia, Spain
• Novartis Investigative Site — Geneva, Switzerland

Full record on ClinicalTrials.gov

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