Actively Recruiting
PSMA PET Combined With MRI for the Detection of PCa
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2025-09-10
204
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
T
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor
T
Telix Innovations S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PSMA PET Combined With MRI for the Detection of PCa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, at least 18 years old
- Clinical suspicion of prostate cancer with planned template biopsy based on MRI results (PI-RADS 3-4) within 3 months or clinical risk factors if MRI shows PI-RADS 1-2
- No previous prostate biopsy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Ability to understand and comply with study requirements
- Consent to anatomical template biopsy with or without targeted biopsy based on clinical risk, MRI, and PSMA PET results
- Agreement to follow radiation protection precautions, especially if female partner is or could be pregnant
- Agreement to use adequate contraception to prevent pregnancy in female partners during the study
You will not qualify if you...
- Prior treatment or diagnosis of clinically significant prostate cancer
- Evidence of metastatic disease on prior imaging
- Previous diagnosis of any cancer except certain treated skin cancers
- Active prostate infection or urinary tract infection within 4 weeks before enrollment
- Prior pelvic radiation
- Radiographic findings of PI-RADS 5
- Abnormal physical exam or lab tests affecting safety or compliance
- Inability or unwillingness to provide informed consent or follow study procedures
- Unable to tolerate or remain supine for PET/CT scan
- Allergy or intolerance to investigational drug or its components
- Prior use of radionuclides within 10 effective half-lives before study drug administration
- Participation in other experimental drug or device trials outside standard care during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Australian Prostate Centre
Melbourne N., Victoria, Australia, 3055
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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