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New PET scan agent shows promise for spotting prostate cancer

NCT ID NCT04838626

Diagnosis Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging agent called [18F]CTT1057 for PET scans to see how well it can find prostate cancer tumors. 195 men with high-risk prostate cancer who were scheduled for surgery received the scan. The results were compared to tissue samples taken during surgery to measure accuracy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

195 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level \>20ng/ml or Gleason score ≥8) (D'Amico et al 1998) * Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment * ECOG performance status 0-2 * Signed informed consent must be obtained prior to participation in the study * 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. * Known allergy, hypersensitivity, or intolerance to \[18F\]CTT1057 * Prior and current use of PSMA targeted therapies * Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists) * Any 5-alpha reductase inhibitors within 30 days before screening * Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue * Patients with incidental PCa after transurethral resection * Use of other investigational drugs within 30 days before screening

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer Prostatic neoplasms

Contacts and locations

Locations

  • Explorer Molecular Imaging center

    Sacramento, California, 95816, United States

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Nîmes, 30029, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Bellinzona, 6500, Switzerland

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

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