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PSMA PET/CT Scan for Prostate Cancer

Phase 3
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 hours after tracer injection
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if 18F-PSMA-1007 PET/CT imaging is safe and effective in adults with prostate cancer.

Who is the study for?
This trial is for adults with prostate cancer who've had surgery or other treatments like radiotherapy, and now have rising PSA levels or high-risk features indicating possible metastatic disease. It's also open to those where a PET/CT scan might help in their care as decided by certain specialists in Alberta.
What is being tested?
The study tests the safety and effectiveness of a new imaging tracer called 18F-PSMA-1007 used in PET/CT scans. It aims to improve detection of prostate cancer spread, especially evaluating non-specific bone lesions to see if they're benign or malignant.
What are the potential side effects?
Possible side effects include reactions at the injection site, general discomfort post-injection, and any delayed adverse events within a week after receiving the tracer which participants are instructed to report.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 hours after tracer injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 hours after tracer injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Non-specific bone lesion assessment (NSBLs)
Safety - delayed
Safety - immediate
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-PSMA-1007Experimental Treatment1 Intervention
18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-PSMA-1007
2022
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
431,609 Total Patients Enrolled
10 Trials studying Prostate Cancer
2,814 Patients Enrolled for Prostate Cancer
~1867 spots leftby Dec 2028
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