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Study of Diagnostic Performance of [18F]CTT1057 in BCR (GuidePath)

Primary Purpose

Prostatic Neoplasms, Prostate Cancer, Recurrence

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
[18F]CTT1057
[68Ga]Ga-PSMA-11
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring [18F]CTT1057, [68Ga]Ga-PSMA-11, Positron Emission Tomography/Computerized Tomography, PET/CT, Radioligand, Imaging, Biochemical recurrence, BCR, Composite Truth Standard, CTS, Prostate Cancer, PCa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Explorer Molecular Imaging centerRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa

Arm Description

All eligible participants will be 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 apart

Outcomes

Primary Outcome Measures

Region-level correct localization rate (CLR) of [18F]CTT1057
Region-level correct localization rate (CLR) is defined as the proportion of regions containing at least one True Positive(TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level positive predictive value (PPV) (with anatomical localization) of [18F]CTT1057
Patient-level positive predictive value (PPV) is defined as the proportion of patients who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are PET/CT scan positive. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)

Secondary Outcome Measures

Patient-level sensitivity of [18F]CTT1057
Patient-level sensitivity is defined as the proportion of patients that test positive on [18F]CTT1057 and CTS (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level specificity of [18F]CTT1057
Patient-level specificity is defined as the proportion of patients that test negative on [18F]CTT1057 and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or False Positive (FP)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level negative predictive value of [18F]CTT1057
Patient-level negative predictive value is defined as the proportion of patients who are both [18F]CTT1057 and CTS negative (True Negative (TN)) among those who test negative on [18F]CTT1057 (True Negative (TN) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level accuracy of [18F]CTT1057
Patient-level accuracy is defined as the proportion of patients that are CTS and [18F]CTT1057 positive (True Positive (TP)) and negative (True Negative (TN)) among those patients that identified on [18F]CTT1057 (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level correct detection rate (CDR)
Patient-level correct detection rate (CDR) is defined as the proportion of patients who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are scanned. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level detection rate
Patient-level detection rate is defined as the proportion of patients who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all patients who are scanned. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).
Region level sensitivity of [18F]CTT1057
Region level sensitivity is defined as the proportion of regions that test positive on both [18F]CTT1057 and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Region level specificity of [18F]CTT1057
Region level specificity is defined as the proportion of regions that test negative on both [18F]CTT1057 and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Region level negative predictive value of [18F]CTT1057
Region level negative predictive value is defined as the proportion of regions that are CTS and [18F]CTT1057 negative (True Negative (TN)) among those regions that test negative on [18F]CTT1057 (True Negative (TN) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Region level accuracy of [18F]CTT1057
Region level accuracy is defined as the proportion of regions that are CTS and [18F]CTT1057 positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on [18F]CTT1057 (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Patient-level positive predictive value related to PSA levels
Patient-level positive predictive value related to PSA levels is defined as the percentage of patients who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between [18F]CTT1057 PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are [18F]CTT1057 positive, stratified by PSA levels. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Characterize the safety and tolerability of [18F]CTT1057
The distribution of adverse events (AEs) within 14 days after each PET tracer administration will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
[18F]CTT1057 scan inter-reader variability
Inter-reader variability is defined as the agreement among three readers determination of [18F]CTT1057 images. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
[18F]CTT1057 scan intra-reader variability
Intra-reader variability is defined as the within-reader agreement for two different time points of [18F]CTT1057 images. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of lesions at lesion level using central reads
Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of detection of PSMA-positive lesions (location and number) using central reads. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).
Change in patient management plans attributed to the [18F]CTT1057 PET/CT scan
Change in patient management plans attributed to the PET/CT scan is defined as the percentage of patients who underwent a change in intended treatment plan attributed to the [18F]CTT1057 PET/CT scan as assessed by pre and post imaging questionnaires. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).

Full Information

First Posted
April 7, 2021
Last Updated
October 24, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04838613
Brief Title
Study of Diagnostic Performance of [18F]CTT1057 in BCR
Acronym
GuidePath
Official Title
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)]
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
October 23, 2023 (Anticipated)
Study Completion Date
November 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
Detailed Description
This is a prospective, open-label, multi center, single-arm Phase III study to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors in PCa patients diagnosed with biochemical recurrence (BCR) after initial definitive therapy with either radical prostatectomy (RP) or curative intent radiation therapy (RT), using a CTS as reference. The CTS to be used as reference will be hierarchical in nature, with 3 levels of Standard of Truth (SoT) procedures, that will be applied as follows: CTS Level 1: Histopathology if available for the lesion (from prospective biopsy or salvage surgery performed within 8 weeks after the [18F]CTT1057 PET/CT scan); OR in case that histopathology is not available for a lesion, inconclusive or negative (for biopsy only): CTS Level 2: Imaging diagnostic procedures performed on each patient as clinically indicated per SoC, which must include at least a high resolution CT scan with contrast and a [68Ga]Ga-PSMA-11 PET/CT) performed within 8 weeks (either before or after) the [18F]CTT1057 PET/CT scan. Three-month follow-up imaging (from baseline) will also be used as part of the CTS level 2 in cases where it is clinically required for the diagnosis of particular lesion(s); OR if neither of the two above are feasible or deemed appropriate or they are inconclusive: CTS Level 3: 50% or greater decline in PSA following radiation therapy (as long as no concomitant androgen deprivation therapy (ADT) is given) as per Prostate Cancer Working Group 3 (PCWG3) criteria. All participants will undergo 2 PET/CT scans: one with the investigational agent [18F]CTT1057 and another with [68Ga]Ga-PSMA-11 (as a component of the CTS Level 2 and for a secondary endpoint of assessment of concordance between the 2 PET/CT scans for detection of lesions). The 2 PET imaging procedures will be performed at least 14 days apart, and the PET/CT scan sequence for each participant will be assigned at random in a 1:1 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer, Recurrence
Keywords
[18F]CTT1057, [68Ga]Ga-PSMA-11, Positron Emission Tomography/Computerized Tomography, PET/CT, Radioligand, Imaging, Biochemical recurrence, BCR, Composite Truth Standard, CTS, Prostate Cancer, PCa

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Once eligibility is confirmed, the participants will be randomized in IRT to be 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 apart
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa
Arm Type
Experimental
Arm Description
All eligible participants will be 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 apart
Intervention Type
Drug
Intervention Name(s)
[18F]CTT1057
Intervention Description
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-PSMA-11
Intervention Description
Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan
Primary Outcome Measure Information:
Title
Region-level correct localization rate (CLR) of [18F]CTT1057
Description
Region-level correct localization rate (CLR) is defined as the proportion of regions containing at least one True Positive(TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level positive predictive value (PPV) (with anatomical localization) of [18F]CTT1057
Description
Patient-level positive predictive value (PPV) is defined as the proportion of patients who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are PET/CT scan positive. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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 Outcome Measure Information:
Title
Patient-level sensitivity of [18F]CTT1057
Description
Patient-level sensitivity is defined as the proportion of patients that test positive on [18F]CTT1057 and CTS (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level specificity of [18F]CTT1057
Description
Patient-level specificity is defined as the proportion of patients that test negative on [18F]CTT1057 and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or False Positive (FP)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level negative predictive value of [18F]CTT1057
Description
Patient-level negative predictive value is defined as the proportion of patients who are both [18F]CTT1057 and CTS negative (True Negative (TN)) among those who test negative on [18F]CTT1057 (True Negative (TN) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level accuracy of [18F]CTT1057
Description
Patient-level accuracy is defined as the proportion of patients that are CTS and [18F]CTT1057 positive (True Positive (TP)) and negative (True Negative (TN)) among those patients that identified on [18F]CTT1057 (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level correct detection rate (CDR)
Description
Patient-level correct detection rate (CDR) is defined as the proportion of patients who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are scanned. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level detection rate
Description
Patient-level detection rate is defined as the proportion of patients who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all patients who are scanned. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).
Time Frame
[18F]CTT1057 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)
Title
Region level sensitivity of [18F]CTT1057
Description
Region level sensitivity is defined as the proportion of regions that test positive on both [18F]CTT1057 and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Time Frame
[18F]CTT1057 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)
Title
Region level specificity of [18F]CTT1057
Description
Region level specificity is defined as the proportion of regions that test negative on both [18F]CTT1057 and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Time Frame
[18F]CTT1057 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)
Title
Region level negative predictive value of [18F]CTT1057
Description
Region level negative predictive value is defined as the proportion of regions that are CTS and [18F]CTT1057 negative (True Negative (TN)) among those regions that test negative on [18F]CTT1057 (True Negative (TN) or False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients post-prostatectomy and patients after prostate radical radiotherapy (RT).
Time Frame
[18F]CTT1057 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)
Title
Region level accuracy of [18F]CTT1057
Description
Region level accuracy is defined as the proportion of regions that are CTS and [18F]CTT1057 positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on [18F]CTT1057 (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (FN)). The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Patient-level positive predictive value related to PSA levels
Description
Patient-level positive predictive value related to PSA levels is defined as the percentage of patients who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between [18F]CTT1057 PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all patients who are [18F]CTT1057 positive, stratified by PSA levels. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Characterize the safety and tolerability of [18F]CTT1057
Description
The distribution of adverse events (AEs) within 14 days after each PET tracer administration will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time Frame
From first dosing (Day 1) up to 14 days post dosing
Title
[18F]CTT1057 scan inter-reader variability
Description
Inter-reader variability is defined as the agreement among three readers determination of [18F]CTT1057 images. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
[18F]CTT1057 scan intra-reader variability
Description
Intra-reader variability is defined as the within-reader agreement for two different time points of [18F]CTT1057 images. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT)
Time Frame
[18F]CTT1057 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)
Title
Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of lesions at lesion level using central reads
Description
Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of detection of PSMA-positive lesions (location and number) using central reads. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).
Time Frame
[18F]CTT1057 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)
Title
Change in patient management plans attributed to the [18F]CTT1057 PET/CT scan
Description
Change in patient management plans attributed to the PET/CT scan is defined as the percentage of patients who underwent a change in intended treatment plan attributed to the [18F]CTT1057 PET/CT scan as assessed by pre and post imaging questionnaires. The endpoint will be analyzed overall in the Efficacy Analysis Set (EFF population) and in each of the following subgroups: Patients with prior Radical Prostatectomy and patients with prior curative intent Radiation Therapy (RT).
Time Frame
From randomization up to 14 days after obtaining the results of the [18F]CTT1057 PET imaging

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Explorer Molecular Imaging center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anh Nguyen
Phone
916-734-5560
Email
atunguyen@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Lorenzo Nardo
Facility Name
Novartis Investigative Site
City
Marseille Cedex 05
ZIP/Postal Code
13885
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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