RecruitingPhase 3

PSMA PET Combined With MRI for the Detection of PCa

United States, Australia338 participantsStarted 2025-08-18

Plain-language summary

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, at least 18 years old.
. 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):
. Prostate biopsy naïve.
. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
. Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
. Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Objective

Timeframe: 12 months

Co-Primary Endpoint

Timeframe: 12 months

Trial details

NCT IDNCT07052214

SponsorTelix Pharmaceuticals (Innovations) Pty Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More PCA trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, at least 18 years old.
. 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):
. Prostate biopsy naïve.
. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
. Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
. Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result.
. 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.

PSMA PET Combined With MRI for the Detection of PCa

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

PSMA PET Combined With MRI for the Detection of PCa

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria