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New imaging agent could spot returning prostate cancer earlier

NCT ID NCT04838613

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 study tested a new radioactive tracer called [18F]CTT1057 for PET/CT scans in 190 men with prostate cancer whose PSA levels were rising after initial treatment. The goal was to see if the tracer could accurately locate where the cancer had returned. Participants received both the new tracer and a standard one for comparison.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[18F]CTT1057 (a radioactive tracer for PET scans)
What this could lead to
If successful, this could provide a more accurate way to detect where prostate cancer has returned after initial treatment, helping guide further therapy.
What could go wrong
This is a diagnostic study, not a treatment. The tracer may not be more effective than existing options, and false positives or negatives are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

190 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 * 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

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm Recurrence

As listed by the trial registrant

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

Prostate cancer Prostatic neoplasms Recurrence

Contacts and locations

Locations

  • Explorer Molecular Imaging center

    Sacramento, California, 95816, United States

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Nîmes, 30029, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42270, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • 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

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

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