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New scan could spot prostate cancer more accurately

NCT ID NCT07052214

Diagnosis Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether combining a special PET scan (PSMA PET) with MRI can detect prostate cancer better than standard methods. About 204 men with suspected prostate cancer will receive the combined imaging, and results will be compared to biopsy findings. The goal is to see if this approach improves accuracy and reduces unnecessary procedures.

What this could mean

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

Active substance
68Ga-PSMA-11 (Gallium Ga 68 Gozetotide)
What this could lead to
If successful, this could make prostate cancer detection more accurate, reducing unnecessary biopsies and catching cancers earlier.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The new scan may not prove better than current methods, and false positives or negatives remain 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

About 338 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Male, at least 18 years old. 2. Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and/or have non-imaging risk factors (including but not exclusive to): a) Persistently elevated or rising PSA b) High PSA density c) Abnormal digital rectal examination (DRE) d) Strong family history of prostate cancer: i. First-degree relative (father or brother) with csPCa ii. Any relative diagnosed at \<65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g. BReast CAncer gene \[BRCA\]1/2, Homeobox protein Hox-B13 \[HOXB13\] mutations) e) Other high-risk biomarkers: i. 4Kscore ii. PHI (Prostate Health Index) iii. High Prostate Cancer Antigen 3 (PCA3) iv. Any other established biomarker with values in the high-risk range f) Clinical presentation: i. Symptoms suggestive of locally advanced disease (e.g. urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern 3. Prostate biopsy naïve. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines. 5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 6. Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result. 7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant. 8. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \[Clinical Trial Facilitation Group\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Has prior diagnosis of csPCa 2. Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy). 4\. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment. 5\. Prior pelvic irradiation 6. Demonstrate radiographic findings of PI-RADS 5. 7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and/or is deemed not suitable for participating in this trial in the opinion of the investigator. 8\. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator. 9. Is unable to attain or remain in a supine position while a PET/CT scan is being performed or unable to tolerate a PET/CT scan 10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug/comparator or its excipients. 11\. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11. 12\. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens/interventions would be deemed eligible to enroll.

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Conditions

The condition(s) this trial relates to.

choanal atresia prostate cancer prostate carcinoma

As listed by the trial registrant

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

Carcinoma of the prostate Diagnostic imaging Elevated PSA PCA Positron emission tomography Prostate biopsy Prostate cancer Prostatic neoplasm PSMA pet

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Urology Specialists

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Australian Prostate Centre

    RECRUITING

    Melbourne N., Victoria, 3055, Australia

    Contact Email: •••••@•••••

  • Impression Imaging

    RECRUITING

    Boca Raton, Florida, 33433, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • MidLantic Urology

    RECRUITING

    Philadelphia, Pennsylvania, 19004, United States

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Southern Urology

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • St Vincent's Hospital Sydney

    RECRUITING

    Sydney, Australia

  • The Conrad Pearson Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • UroPartners,LLC

    RECRUITING

    Chicago, Illinois, 60657, United States

  • Urology Associates of Nashville

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology of Virginia

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell

    RECRUITING

    New York, New York, 10065, United States

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