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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    190
  • sponsor
    Novartis Pharmaceuticals
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Updated on 3 April 2023
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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.

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.

Details
Condition Prostatic Neoplasms, Prostate Cancer, Recurrence
Treatment [18F]CTT1057, [68Ga]Ga-PSMA-11
Clinical Study IdentifierNCT04838613
SponsorNovartis Pharmaceuticals
Last Modified on3 April 2023

Eligibility

 Yes No Not Sure

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
Participants must be adults ≥ 18 years of age
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

Exclusion Criteria

Prior and current use of PSMA targeted therapies
Inability to complete the needed investigational and standard-of-care imaging
examinations due to any reason (severe claustrophobia, inability to lie still for the
Any 5-alpha reductase inhibitors within 30 days before screening
entire imaging time, etc.)
Any additional medical condition, serious intercurrent illness, concomitant cancer or
Use of other investigational drugs within 30 days before screening
other extenuating circumstance that, in the opinion of the Investigator, would
Castration-resistant patients
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 ADT (first or second generation), including LHRH analogues (agonists or
antagonists), within 9 months before screening
Patient with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
Prior salvage surgery or salvage radiation therapy
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