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

Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

ClinicalTrials.gov Identifier: NCT04838613

Novartis Reference Number: CAAA405A12301

Last Update: May 11, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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 are evaluable (i.e. have both an evaluable [18F]CTT1057 PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures), which will be required for the calculation of the co-primary endpoints.

Condition

Prostatic Neoplasms

Prostate Cancer

Recurrence

Phase

Phase 3

Overall status

Recruiting

Start date

Sep 30, 2021

Completion date

Dec 13, 2023

Gender

Male

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

[18F]CTT1057

Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan

Drug

[68Ga]Ga-PSMA-11

Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan

Eligibility Criteria

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