Actively Recruiting
PSMA PET Combined With MRI Compared to Standard Care for Detecting Prostate Cancer An Open Label, Single Arm, Multicenter Phase 3 Study
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2025-09-10
204
Participants Needed
1
Research Sites
21 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
Researchers are evaluating the use of a combined imaging approach using prostate specific membrane antigen (PSMA) positron emission tomography (PET) and magnetic resonance imaging (MRI) to detect prostate cancer (PCa). This open label, single arm, Phase 3 study aims to compare this combined method against the current standard of care for detecting clinically significant prostate cancer. The study will enroll 204 men suspected of having PCa and will be conducted at multiple sites in the United States and Australia. All participants will undergo both MRI and PSMA PET scans after receiving a single intravenous dose of Gallium Ga 68 Gozetotide, a radioactive tracer used for imaging. Following imaging, participants will have a standard 12-core template biopsy to confirm the presence of cancer. If additional suspicious lesions appear on imaging, targeted biopsies may also be performed. Clinical decisions including whether to biopsy or use imaging to rule out biopsy will be made by the treating clinician. Participants diagnosed with clinically significant prostate cancer will receive treatment as per standard institutional practice or clinician judgment. During the study, researchers will collect follow-up data for up to six months to monitor participants without baseline evidence of prostate cancer. Additional imaging and biopsies may be performed during this period to ensure accurate diagnosis. The study will measure outcomes related to the detection accuracy of the combined imaging method compared to standard biopsy procedures. Safety, compliance with radiation precautions, and clinical status will be monitored throughout the study, which is planned to run until November 2026.
CONDITIONS
Brief 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 or clinical risk factors
- No prior prostate biopsy
- Eastern Cooperative Oncology Group performance status of 2 or less
- Ability to understand the study and comply with protocol requirements
- Consent to anatomical template biopsy with or without targeted biopsy
- Compliance with radiation protection rules and contraceptive measures to protect female partners
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 skin cancers treated curatively
- Active prostate or urinary tract infection within 4 weeks before enrollment
- Prior pelvic radiation therapy
- Radiographic findings of PI-RADS 5
- Abnormal physical exam or lab tests affecting safety or compliance
- Unable or unwilling to sign informed consent or follow study procedures
- Unable to tolerate PET/CT scan or remain supine during imaging
- Known allergies or intolerance to investigational drug or its components
- Recent radionuclide exposure within 10 effective half-lives before study drug administration
- Participation in other experimental drug or device trials outside standard care during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months before enrollment and biopsy procedures at enrollment
Participants undergo MRI and PSMA PET scans followed by a standard 12-core anatomical template biopsy. Additional targeted biopsies may be performed based on imaging findings and clinician judgment.
1 imaging visit and 1 biopsy visit (in-person)
Duration - Up to 6 months
Participants without baseline imaging or histopathological evidence of prostate cancer will be followed for up to 6 months. Additional imaging and biopsies may occur as needed for ongoing surveillance.
Follow-up visits as needed depending on clinical decisions
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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