Phase 3
N=190
Study of Diagnostic Performance of [18F]CTT1057 in BCR
Prostatic Neoplasms · Prostate Cancer · Recurrence
Bottom Line
View on ClinicalTrials.gov: NCT04838613 ↗Enrolled (actual)
190
Serious AEs
0.3%
Results posted
Mar 2025
Primary outcome: Primary: Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F) — 75.0; 68.9; 65.2 Percentage of regions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [18F]CTT1057 (Drug); [68Ga]Ga-PSMA-11 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F) |
75.0; 68.9; 65.2 | — |
| PRIMARY Patient-level Positive Predictive Value (PPV) (With Anatomical Localization) of Vidoflufolastat (18F) |
76.5; 69.0; 64.6 | — |
| SECONDARY Patient-level Sensitivity of Vidoflufolastat (18F) |
63.9; 66.7; 71.2 | — |
| SECONDARY Patient-level Specificity of Vidoflufolastat (18F) |
88.0; 82.2; 77.5 | — |
| SECONDARY Patient-level Negative Predictive Value (NPV) of Vidoflufolastat (18F) |
80.0; 80.6; 82.3 | — |
| SECONDARY Patient-level Accuracy of Vidoflufolastat (18F) |
78.9; 76.4; 75.2 | — |
| SECONDARY Patient-level Correct Detection Rate (CDR) |
24.2; 24.8; 26.1 | — |
| SECONDARY Patient-level Detection Rate |
31.7; 36.0; 40.4 | — |
| SECONDARY Region-level Sensitivity of Vidoflufolastat (18F) (Overall) |
53.2; 58.2; 58.0 | — |
| SECONDARY Region Level Specificity of Vidoflufolastat (18F) |
98.1; 97.1; 96.5 | — |
| SECONDARY Region Level Negative Predictive Value (NPV) of Vidoflufolastat (18F) |
95.1; 95.5; 95.4 | — |
| SECONDARY Region Level Accuracy of Vidoflufolastat (18F) |
93.7; 93.3; 92.7 | — |
| SECONDARY Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels |
60.9; 59.3; 53.3; 100; 66.7; 76.9 | — |
| SECONDARY Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) |
20; 16; 6; 2; 1; 0 | — |
| SECONDARY Vidoflufolastat (18F) Scan Inter-reader Variability |
65.5 | — |
| SECONDARY Vidoflufolastat (18F) Scan Intra-reader Variability |
61.2; 100; 100 | — |
| SECONDARY Concordance Between Vidoflufolastat (18F) and Gallium (68Ga) Gozetotide for Detection of Lesions at Lesion Level Using Central Reads (Overall) |
51.1; 48.2; 55.1 | — |
| SECONDARY Change in Patient Management Plans Attributed to the Vidoflufolastat (18F) PET/CT Scan |
61 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04838613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.