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)]

Official 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 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 100 Years
• Sex: MALE

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 190 participants

Study Arms

• PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa (EXPERIMENTAL)
  All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio: * Sequence 1: \[18F\]CTT1057 on Day 1 (investigational imaging agent of interest) followed by \[68Ga\]Ga-PSMA-11 at least 14 days apart (as part of CTS if required, and for secondary endpoint) * Sequence 2: \[68Ga\]Ga-PSMA-11 (as part of CTS if required, and for secondary endpoint) on Day 1 followed by \[18F\]CTT1057 (investigational imaging agent of interest) at least 14 days apa

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

Primary Outcomes

• Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))
• Patient-level Positive Predictive Value (PPV) (With Anatomical Localization) of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))

Secondary Outcomes

• Patient-level Sensitivity of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))
• Patient-level Specificity of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))
• Patient-level Negative Predictive Value (NPV) of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))
• Patient-level Accuracy of Vidoflufolastat (18F) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))
• Patient-level Correct Detection Rate (CDR) (vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment))

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

Trial Locations

• 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
• ...and 3 more locations

Study Officials

• Novartis Pharmaceuticals — STUDY_DIRECTOR
  Novartis Pharmaceuticals

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