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

• Status: Recruiting
• Trial end date: 2023-06-09
• Target enrollment: 0
• Participant gender: Male

Summary

The current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.

Approximately 190 participants will be enrolled to ensure at least 152 participants to complete the [18F]CTT1057 PET/CT scan procedure (i.e. investigational imaging agent administration and successful completion of the PET/CT scan), which will be required for the calculation of the co-primary endpoints.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study

• Biopsy proven prostate adenocarcinoma.

• 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).

• Eastern Cooperative Oncology Group (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 reasons (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 Coronavirus Disease 2019 (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 and current treatment with Luteinizing Hormone-Releasing Hormone (LHRH) analogues

• Any prior ADT (first or second generation) 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

• Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue