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Radiopharmaceutical

[18F] PSMA-1007 Injection for Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Centre for Probe Development and Commercialization
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 8 months
Awards & highlights

Study Summary

This study is evaluating whether a PET scan with a PSMA ligand can detect prostate cancer in men with biochemical failure but negative or equivocal conventional re-staging imaging.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint
Secondary outcome measures
Frequency with which [18F]PSMA-1007 PET/CT results lead to a change in recommended management
Percentage of patients identified with recurrent disease using [18F]PSMA-1007
Safety: Occurrence of AEs, SAEs, and changes from baseline in vital signs
Other outcome measures
Imaging concordance (sensitivity, specificity, PPV, NPV) based on [18F]PSMA-1007 PET/CT (at the regional level) compared with clinical outcome information (e.g., conventional imaging, clinical outcome surrogate or histopathologic correlate)
Percentage of patients with detectable disease relative to PSA levels

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]PSMA-1007 InjectionExperimental Treatment1 Intervention
A single dose of 3 - 4 MBq/kg Body Weight (up to a maximum of 400 MBq) of [18F]PSMA-1007 Injection will be administered followed by PET/CT imaging. (Patients on ADT treatment will receive the second dose approximately 6 months after the first dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F] PSMA-1007 Injection
2020
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

Centre for Probe Development and CommercializationLead Sponsor
6 Previous Clinical Trials
3,213 Total Patients Enrolled
1 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer
McDougall Scientific Ltd.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.
2020. "Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04644822.
~23 spots leftby Apr 2025
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